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RecruitingNCT06377397SAUNAUpdated Oct 27, 2026

Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm Neonates

A Phase 3 interventional study of Antibiotics in Sepsis, PROM, Preterm (Pregnancy) and Early-Onset Neonatal Sepsis, sponsored by Indian Council of Medical Research. Recruiting at 9 sites in India. Open to participants aged 4 Hours to 4 Hours. Per ClinicalTrials.gov, last updated 2026-10-27.

Primary conditionNeonatal SepsisRegistry: SepsisReclassifiedWhy we changed it
Registry
Sepsis — the first condition term the registry derived for this study.
ClinicalTrials.gg
Neonatal Sepsis
Why
  1. The study's listed conditions name Neonatal Sepsis, a narrower term within Sepsis.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Indian Council of Medical Research · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2025; still recruiting 1 year 5 months later.
Updated Oct 27, 2026Now RecruitingStudy documents posted+7 moreGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
1,500
Allocation
Randomized
Ages
4 Hours to 4 Hours
Sex
All
01

Study summary

Preterm infants are born at less than 37 weeks of pregnancy. Sometimes a break or tear in the fluid filled bag that surrounds and protects the infant during pregnancy leads to an untimely birth. This state puts the infant at risk of serious condition called sepsis. Sepsis is a condition in which body responds inappropriately to an infection. Sepsis may progress to septic shock which can result in the loss of life. Doctors give antibiotics to treat sepsis.

The goal of this research study is to find out:

  1. Among neonates at risk of early-onset neonatal sepsis, whether a policy of administering antibiotics selectively to a subset of at-risk infants who later develop signs of sepsis is not inferior to administering antibiotics to all at-risk infants in the 1st week of life.
  2. To find out if infants receiving selective antibiotics (as above) compared to those receiving antibiotics from soon after birth (as above) require fewer antibiotic courses cumulatively of more than 48 hours duration in the 1st week of life.
  3. To find out whether infants receiving selective antibiotics (as above) compared to those receiving antibiotics from soon after birth (as above) are significantly different with respect to a wide range of secondary outcomes (listed under "Outcomes").
Read the detailed description

Sepsis is the major cause of neonatal mortality and early-onset neonatal sepsis (EONS) accounts for more than two-thirds of all cases of neonatal sepsis. Prolonged rupture of membranes (ROM) and preterm premature rupture of membranes (pPROM) are important risk factors of EONS. There is equipoise in the published literature whether antibiotics must be immediately initiated among all preterm neonates (\<35 weeks gestation) delivered following prolonged ROM or pPROM who are asymptomatic until 4 hours of life or whether antibiotics can be selectively administered if and when the at-risk neonates become symptomatic.

Research question: Among neonates \<35 weeks gestation born with ROM >18 hours or pPROM and who are either asymptomatic or have no symptoms of sepsis at 4 hrs postnatally (P), is selectively administering antibiotics to neonates who later develop clinical sepsis [I] compared to administering antibiotics pre-emptively to all at-risk neonates [C] non-inferior with respect to the composite outcome of "all-cause mortality and/or culture-positive sepsis and/or severe sepsis" [O] within 7 days (i.e. 168 hours) after the randomization [T] by an absolute risk difference of 7% [E] in a randomized controlled trial (S)? The trial will also have a composite superiority outcome: "all-cause mortality within 7 days (i.e. 168 hours) after randomization, or cumulative intravenous antibiotic exposure exceeding 48 hours during those same 168 hours, summed across all antibiotic courses". The absolute risk difference for the superiority outcome will be 50%.

The main objectives are as follows:

  1. To determine whether antibiotics administered selectively to at-risk preterm neonates [\<35 weeks gestation with prolonged rupture of membranes (ROM) or preterm premature rupture of membranes (pPROM)] when they develop signs of sepsis compared to administering antibiotics from 4 hours of life to all at-risk neonates is non-inferior with respect to the primary composite outcome of "all-cause mortality or any episode of culture-positive sepsis or severe sepsis" in the 1st 7 days after randomization
  2. To determine whether neonates receiving selective antibiotics (as above) compared to those receiving antibiotics from 4 hours of life (as above) are superior with respect to the co-primary composite outcome of "all-cause mortality within 7 days after randomisation, or cumulative intravenous antibiotic exposure exceeding 48 hours during those same 7 days, summed across all antibiotic courses".
  3. To determine whether neonates receiving selective antibiotics (as above) compared to those receiving antibiotics from birth (as above) are significantly different with respect to a wide range of secondary outcomes (listed under "Outcomes")
02

Conditions studied

  • Sepsis
  • PROM, Preterm (Pregnancy)
  • Early-Onset Neonatal Sepsis
  • Preterm Premature Rupture of Membrane
  • Preterm Birth

Keywords

  • Prolonged rupture of membranes
  • Preterm premature rupture of membranes
  • Early-onset neonatal sepsis
  • Selective antibiotics
  • Non-inferiority trial
03

In context

Neonatal Sepsis Reclassified

192 studies on the registry are indexed under Neonatal Sepsis; 41 are open to participants now.

This study's planned enrollment of 1,500 is above the median of 181 across 102 interventional studies indexed under Neonatal Sepsis.

Browse Neonatal Sepsis studies →

Lead sponsor

Indian Council of Medical Research is the lead sponsor of 12 studies on the registry; 3 are open to participants now.

Compared within Neonatal Sepsis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Sepsis. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

The criteria were revised on the registry on Oct 27, 2026. See what changed

Ages eligible
4 Hours to 4 Hours
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Gestational age of 26 0/7 to 34 6/7 weeks
  • Chronological age 4 hours

  • Have any one or both of the following risk factors of EONS:

    • Prolonged rupture of membranes >18 hours
    • Pre-labour rupture of membranes [as all subjects will be preterm, this is effectively pPROM]

  • Are either asymptomatic or have no signs attributable to sepsis at 4 hours. This will be defined as absence of the following clinical signs or need for interventions mentioned below:

    1. Apnea (Standard definition) requiring intervention at any time until enrolment.
    2. Need for a fluid bolus or inotropic support at any time until enrolment.
    3. Seizures or seizure-like activity at any time until enrolment.
    4. Upper GI bleed in the absence of a history of ante-partum hemorrhage at any time until enrolment.
    5. Pus from any site at any time until enrolment.
    6. Need for CPAP >6 cms of water with FiO2 >35% at 4 hours OR need for CPAP less than or equal to 6 cms and FiO2 less than or equal to 35% but with increasing requirement of support
    7. Chest Xray (if performed) with radiological features of pneumonia.
    8. Need for intubation and mechanical ventilation.
    9. Temperature >37.5°C or \<36°C, unexplained by environmental causes
    10. Feed intolerance [bilious or bloodstained vomiting (or gastric residuals) or visibly distended abdomen or >50% of the previous feed volume as gastric residuals]
    11. Lethargy or unarousability
    12. Sclerema

Exclusion criteria

Exclusion Criteria:

Subjects will be excluded if they have any 1 of the following:

<!-- -->

  1. Life-threatening congenital malformation
  2. Severe perinatal asphyxia (Apgar score \<5 at 10 minutes or cord pH \<7.0)
  3. Clinical chorioamnionitis# [see definition below]
  4. Foul-smelling liquor
  5. Multiple gestation
  6. Received a dose of antibiotics
  7. Positive amniotic fluid culture (if performed and available prior to randomization)

  8. Treating neonatologist unwilling to enroll the patient in the trial on the grounds that the patient needs antibiotics.

    -

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
1,500 participants (estimated)

Study arms

  • Experimental
    Selective antibiotic group

    Antibiotics will be administered selectively to a subset of at-risk neonates who develop clinical signs of sepsis.

    Drug: Antibiotics

  • Active comparator
    Comparison group

    Antibiotics will be pre-emptively administered to all neonates at risk of sepsis.

    Drug: Antibiotics

Interventions

  • DrugAntibiotics

    In experimental arm, intravenous antibiotics as per the written down empirical antibody policy of the unit will be administered selectively to those newborn infants who later develop clinical signs of sepsis according to a predefined repertory of clinical signs. In active comparator arm, intravenous antibiotics as per the written down empirical antibody policy of the unit will be administered pre-emptively to all newborn infants from randomization even if they do not have any clinical signs of sepsis at randomization.

    Also known as: Intravenous antibiotics as per written down empirical antibiotic policy of the unit

06

What researchers measure

Primary outcomes

  1. Composite of all-cause mortality and/or any episode of culture-positive sepsis and/or severe sepsis within the 1st 7 days after randomization

    Either mortality due to any cause and/or an episode of culture-positive sepsis and/or severe sepsis. These outcomes will be measured within the 1st 7 days after randomization.

    Time frame: Within 1st 7 days after randomization

  2. All-cause mortality within 7 days (i.e. 168 hours) after randomization, or cumulative intravenous antibiotic exposure exceeding 48 hours during those same 168 hours, summed across all antibiotic courses

    Composite outcome of mortality due to any cause within the 1st 7 days after randomisation and/or requirement for intravenous antibiotic courses whose cumulative duration is \> 48 hours within the first 7 days after randomization

    Time frame: Within 1st 7 days after randomization

Secondary outcomes

  1. All-cause Mortality within 1st 7 days after randomization

    Mortality due to any cause

    Time frame: During 1st 7 days after randomization

  2. Culture-positive sepsis within 1st 7 days after randomization

    Culture-positive sepsis

    Time frame: Within 1st 7 days after randomization

  3. Episode of severe sepsis within 1st 7 days after randomization

    Any episode of severe sepsis during 1st 7 days after randomization. Severe sepsis will be defined as clinical signs of sepsis AND either a positive blood culture or laboratory evidence of sepsis (either CRP OR Procalcitonin above the age-appropriate cut-off value OR any two of the CBC parameters outside the age-appropriate ranges OR chest x-ray suggestive of pneumonia) AND one or more of the following indices of severity \[Need for intubation and mechanical ventilation, Need for inotropes \>10 mic/kg/min dopamine or \>10 mic/kg/min dobutamine or adrenaline \> 0.05 mic/kg/min, Need for exchange transfusion, Need for platelet concentrates or FFP, Meningitis (defined as either CSF culture positive or Gram stain positive or Cell count \>25/microlitre or glucose \<25 mg/dl or protein \>180 mg/dl)\]

    Time frame: Within 1st 7 days after randomization

  4. Composite of mortality/culture positive sepsis/severe sepsis within 1st 72 hours after randomization

    Either mortality and/or culture-positive sepsis and/or severe sepsis

    Time frame: Within first 72 hour after randomization

  5. Individual components of composite outcome within 1st 72 hours after randomization

    Separately mortality, culture-positive sepsis or severe sepsis

    Time frame: Within 1st 72 hours after randomization

  6. Composite of mortality/culture positive sepsis/severe sepsis during hospital stay

    Either mortality due to any cause and/or culture-positive sepsis and/or severe sepsis during hospital stay, with maximum duration of observation during hospital stay being capped at 100 days

    Time frame: During hospital stay capped at 100 days

  7. Individual components of composite outcome during hospital stay

    Separately mortality, culture-positive sepsis or severe sepsis during hospital stay, with maximum duration of observation during hospital stay being capped at 100 days

    Time frame: During hospital stay capped at 100 days

  8. Necrotizing enterocolitis, stage II-III by modified Bell's staging criteria during hospital stay

    Necrotizing enterocolitis stage II-III by modified Bell's staging criteria during hospital stay, with maximum duration of observation during hospital stay being capped at 100 days

    Time frame: During hospital stay capped at 100 days

  9. Composite of mortality/culture positive sepsis/severe sepsis during 1st 30 days of life

    Either all-cause mortality and/or culture-positive sepsis and/or severe sepsis during the 1st 30 days of life

    Time frame: During 1st 30 days of life

  10. Individual components of composite outcome during 1st 30 days

    Separately, all-cause mortality, culture-positive sepsis or severe sepsis during the 1st 30 days of life

    Time frame: During 1st 30 days of life

  11. Necrotizing enterocolitis, stage II-III by modified Bell's staging criteria

    Necrotizing enterocolitis, stage II-III by modified Bell's staging criteria during the 1st 30 days of life

    Time frame: During 1st 30 days of life

  12. Sepsis-related mortality within 1st 72 hours after randomization

    Mortality due to sepsis within 1st 72 hours. The decision of the masked adjudicator will be recorded for attributing mortality to sepsis.

    Time frame: Within 1st 72 hours after randomization

  13. Sepsis-related mortality within 7 day after randomization

    Mortality due to sepsis within 7 days after randomization. The decision of the masked adjudicator will be recorded for attributing mortality to sepsis.

    Time frame: Within 7 days after randomization

  14. Sepsis-related mortality during hospital stay

    Mortality due to sepsis during hospital stay. The decision of the masked adjudicator will be recorded for attributing mortality to sepsis.

    Time frame: During hospital stay capped at 100 days

  15. Sepsis-related mortality during 1st 30 days of life

    Mortality due to sepsis during 1st 30 days of life

    Time frame: During 1st 30 days of life

  16. Clinical sepsis within 1st 72 hours after randomization

    Episodes of clinical EONS (as per definition from a repertoire of clinical signs with normal lab parameters) within 1st 72 hours. The decision of the masked adjudicator will be recorded for diagnosing clinical sepsis.

    Time frame: Within 1st 72 hours after randomization

  17. Clinical sepsis within 7 days after randomization

    Episodes of clinical EONS (as per definition from a repertoire of clinical signs with normal lab parameters) within 7 days. The decision of the masked adjudicator will be recorded for diagnosing clinical sepsis.

    Time frame: Within 7 days after randomization

  18. Clinical sepsis during hospital stay

    Episodes of clinical EONS (as per definition from a repertoire of clinical signs with normal lab parameters) during hospital stay, with maximum duration of observation during hospital stay being capped at 100 days. The decision of the masked adjudicator will be recorded for diagnosing clinical sepsis.

    Time frame: During hospital stay upto 100 days

  19. Clinical sepsis within 1st 30 days of life

    Episodes of clinical EONS (as per definition from a repertoire of clinical signs with normal lab parameters) within 1st 30 days of life. The decision of the masked adjudicator will be recorded for diagnosing clinical sepsis.

    Time frame: During 1st 30 days of life

  20. Episode of Probable EONS within 72 hours after randomization

    Episode of Probable EONS \[as per definition from a repertoire of clinical signs, AND with abnormal age-appropriate values of one or more of TLC, ANC, CRP, PCT, chest x-ray suggestive of pneumonia AND with sterile cultures\]. The decision of the masked adjudicator will be recorded for diagnosing probable sepsis.

    Time frame: Within 72 hours after randomization

  21. Episode of Probable EONS within 7 days after randomization

    Episode of Probable EONS \[as per definition from a repertoire of clinical signs, AND with abnormal age-appropriate values of one or more of TLC, ANC, CRP, PCT, chest x-ray suggestive of pneumonia AND with sterile cultures\]. The decision of the masked adjudicator will be recorded for diagnosing probable sepsis.

    Time frame: Within 7 days after randomization

  22. Episode of asymptomatic proven EONS within 72 hours after randomization

    Episode of asymptomatic proven EONS \[asymptomatic but baseline blood culture positive with non-contaminant organism\]. The decision of the masked adjudicator will be recorded for diagnosing sepsis.

    Time frame: Within 72 hours after randomization

  23. Need for sepsis workup during 1st 72 hours after randomization

    \["Sepsis workup" defined as one or more of CBC, CRP, Procalcitonin, blood culture\] during 1st 72 hours of life

    Time frame: During 1st 72 hours after randomization

  24. Need for sepsis workup during 1st 7 days after randomization

    "Sepsis workup" defined as one or more of CBC, CRP, Procalcitonin, blood culture during 1st 7 days of life

    Time frame: During 1st 7 days after randomization

  25. Need for sepsis workup during 1st 30 days of life

    "Sepsis workup" defined as one or more of CBC, CRP, Procalcitonin, blood culture during 1st 30 days of life

    Time frame: During 1st 30 days of life

  26. Need for sepsis workup during hospital stay

    "Sepsis workup" defined as one or more of CBC, CRP, Procalcitonin, blood culture during hospital stay, with the period of observation during hospital stay being capped at 100 days

    Time frame: During hospital stay capped at 100 days

  27. Cumulative duration of antibiotic therapy during 1st 7 days after randomization

    Cumulative duration of antibiotic therapy during the 1st 7 days, which may include the sum of the durations of multiple courses of antibiotics, either in continuation or discontinuous. If any course of antibiotics continues beyond the 1st 7 days after randomization, only that portion of the antibiotic course would be included until the 1st 7 days after randomization.

    Time frame: During 1st 7 days after randomization

  28. Cumulative duration of antibiotic therapy during 1st 72 hrs after randomization

    Cumulative measure of antibiotics therapy during the 1st 72 hours

    Time frame: During 1st 72 hours after randomization

  29. Cumulative duration of antibiotic therapy during hospital stay

    Cumulative measure of antibiotics therapy during hospital stay, with the period of observation during hospital stay capped at 100 days

    Time frame: During hospital stay capped at 100 days

  30. Duration of hospitalization

    Full length of hospital stay, with the period capped at 100 days

    Time frame: Hospital stay capped at 100 days

  31. Episodes of healthcare associated infection during hospital stay.

    Defined as any episode of culture positive sepsis with onset after 72 hours of life or any episode of culture-positive sepsis if baseline blood culture was sterile, with the period of observation during hospital stay capped at 100 days

    Time frame: From after 72 hours until 100 days during hospital stay

  32. Adverse effects until day 30 of life

    Adverse effects will be recorded as per the Neonatal Adverse Events Severity Scale (NAESS, v1).

    Time frame: During 30 days of life

  33. Serious adverse effects until day 30 of life

    Serious adverse effects will be recorded as per the Neonatal Adverse Events Severity Scale (NAESS, v1).

    Time frame: During 30 days of life

07

Study locations

9 of 9 sites recruiting
  • Government medical College Chandigarh
    Chandigarh, Chandigarh 160012, India
    Recruiting
  • Post Graduate Institute of Medical Education and Research (PGIMER)
    Chandigarh, Chandigarh 160012, India
    Recruiting
  • Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences
    Rohtak, Haryana, India
    Recruiting
  • IGICH bengaluru
    Bengaluru, Karnataka, India
    Recruiting
  • Government Medical College, Aurangabad
    Chhatrapati Sambhajinagar, Maharashtra, India
    Recruiting
  • King Edward Memorial Hospital
    Mumbai, Maharashtra, India
    Recruiting
  • Lady Hardinge Medical College and Kalawati Saran Children's Hospital
    New Delhi, New Delhi 110001, India
    Recruiting
    • Sushma Nangia · Contactdrsnangia@gmail.com · +919810838181
    • Pratima Anand · Contact+919868208708
  • IOG Chennai
    Chennai, Tamil Nadu, India
    Recruiting
  • KGMU Lucknow
    Lucknow, Uttar Pradesh, India
    Recruiting
08

References and documents

Publications

  • Sankar MJ, Neogi SB, Sharma J, Chauhan M, Srivastava R, Prabhakar PK, Khera A, Kumar R, Zodpey S, Paul VK. State of newborn health in India. J Perinatol. 2016 Dec;36(s3):S3-S8. doi: 10.1038/jp.2016.183. PubMed 27924104 ↗
  • Lawn JE, Blencowe H, Oza S, You D, Lee AC, Waiswa P, Lalli M, Bhutta Z, Barros AJ, Christian P, Mathers C, Cousens SN; Lancet Every Newborn Study Group. Every Newborn: progress, priorities, and potential beyond survival. Lancet. 2014 Jul 12;384(9938):189-205. doi: 10.1016/S0140-6736(14)60496-7. Epub 2014 May 19. PubMed 24853593 ↗
  • Chaurasia S, Sivanandan S, Agarwal R, Ellis S, Sharland M, Sankar MJ. Neonatal sepsis in South Asia: huge burden and spiralling antimicrobial resistance. BMJ. 2019 Jan 22;364:k5314. doi: 10.1136/bmj.k5314. PubMed 30670451 ↗
  • Chan GJ, Lee AC, Baqui AH, Tan J, Black RE. Risk of early-onset neonatal infection with maternal infection or colonization: a global systematic review and meta-analysis. PLoS Med. 2013 Aug;10(8):e1001502. doi: 10.1371/journal.pmed.1001502. Epub 2013 Aug 20. PubMed 23976885 ↗
  • Puopolo KM, Benitz WE, Zaoutis TE; COMMITTEE ON FETUS AND NEWBORN; COMMITTEE ON INFECTIOUS DISEASES. Management of Neonates Born at >/=35 0/7 Weeks' Gestation With Suspected or Proven Early-Onset Bacterial Sepsis. Pediatrics. 2018 Dec;142(6):e20182894. doi: 10.1542/peds.2018-2894. PubMed 30455342 ↗
  • Wolf RL, Olinsky A. Prolonged rupture of fetal membranes and neonatal infections. S Afr Med J. 1976 Apr 3;50(15):574-6. PubMed 772827 ↗
  • Berardi A, Fornaciari S, Rossi C, Patianna V, Bacchi Reggiani ML, Ferrari F, Neri I, Ferrari F. Safety of physical examination alone for managing well-appearing neonates >/= 35 weeks' gestation at risk for early-onset sepsis. J Matern Fetal Neonatal Med. 2015 Jul;28(10):1123-7. doi: 10.3109/14767058.2014.946499. Epub 2014 Sep 10. PubMed 25034325 ↗
  • Berardi A, Buffagni AM, Rossi C, Vaccina E, Cattelani C, Gambini L, Baccilieri F, Varioli F, Ferrari F. Serial physical examinations, a simple and reliable tool for managing neonates at risk for early-onset sepsis. World J Clin Pediatr. 2016 Nov 8;5(4):358-364. doi: 10.5409/wjcp.v5.i4.358. eCollection 2016 Nov 8. PubMed 27872823 ↗
  • Berardi A, Spada C, Reggiani MLB, Creti R, Baroni L, Capretti MG, Ciccia M, Fiorini V, Gambini L, Gargano G, Papa I, Piccinini G, Rizzo V, Sandri F, Lucaccioni L; GBS Prevention Working Group of Emilia-Romagna. Group B Streptococcus early-onset disease and observation of well-appearing newborns. PLoS One. 2019 Mar 20;14(3):e0212784. doi: 10.1371/journal.pone.0212784. eCollection 2019. PubMed 30893310 ↗
  • Cantoni L, Ronfani L, Da Riol R, Demarini S; Perinatal Study Group of the Region Friuli-Venezia Giulia. Physical examination instead of laboratory tests for most infants born to mothers colonized with group B Streptococcus: support for the Centers for Disease Control and Prevention's 2010 recommendations. J Pediatr. 2013 Aug;163(2):568-73. doi: 10.1016/j.jpeds.2013.01.034. Epub 2013 Mar 8. PubMed 23477995 ↗
  • Joshi NS, Gupta A, Allan JM, Cohen RS, Aby JL, Weldon B, Kim JL, Benitz WE, Frymoyer A. Clinical Monitoring of Well-Appearing Infants Born to Mothers With Chorioamnionitis. Pediatrics. 2018 Apr;141(4):e20172056. doi: 10.1542/peds.2017-2056. PubMed 29599112 ↗
  • Chiruvolu A, Petrey B, Stanzo KC, Daoud Y. An Institutional Approach to the Management of Asymptomatic Chorioamnionitis-Exposed Infants Born >/=35 Weeks Gestation. Pediatr Qual Saf. 2019 Dec 5;4(6):e238. doi: 10.1097/pq9.0000000000000238. eCollection 2019 Nov-Dec. PubMed 32010864 ↗
  • Investigators of the Delhi Neonatal Infection Study (DeNIS) collaboration. Characterisation and antimicrobial resistance of sepsis pathogens in neonates born in tertiary care centres in Delhi, India: a cohort study. Lancet Glob Health. 2016 Oct;4(10):e752-60. doi: 10.1016/S2214-109X(16)30148-6. PubMed 27633433 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — Anonymized, individual patient data pertaining to publications from the study which are in the public domain will be shared with other researchers planning to conduct a study, upon reasonable written request

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

Time frame: Data will be made available one year after the publication from the study for a period of 3 years

Access criteria: To be decided

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Started Jun 2025 (actual). Primary completion is estimated for Jan 2028, 31 months after the start.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 27, 2026: start Apr 2024 → Jun 2025, primary completion Apr 2027 → Jan 2028 and completion Apr 2028 → May 2028.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Mar 26, 2024
First posted
Apr 22, 2024
StartActual
Jun 7, 2025was Apr 2024
Primary completionEst.
Jan 2028was Apr 2027
CompletionEst.
May 2028was Apr 2028
Last update
Oct 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Oct 27, 2026
Sites
9 sites added, 1 site removed
Show 9 added (9 India)
  • Government medical College Chandigarh · Chandigarh, India
  • Post Graduate Institute of Medical Education and Research (PGIMER) · Chandigarh, India
  • Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences · Rohtak, India
  • IGICH bengaluru · Bengaluru, India
  • Government Medical College, Aurangabad · Aurangabad, India
  • King Edward Memorial Hospital · Mumbai, India
  • Lady Hardinge Medical College and Kalawati Saran Children's Hospital · New Delhi, India
  • IOG Chennai · Chennai, India
  • KGMU Lucknow · Lucknow, India
Show 1 removed
  • Post Graduate Institute of Medical Education and Research (PGIMER) · Chandigarh, India
Oct 27, 2026
Start date
Apr 15, 2024→Jun 7, 2025 (actual)
Oct 27, 2026
Primary completion
Apr 15, 2027→Jan 2028
Oct 27, 2026
Study completion
Apr 14, 2028→May 2028
Oct 27, 2026
Eligibility
Minimum age 0 Hours→4 Hours; 2 inclusion criteria edited
What changed in the criteria
Inclusion criteria
  • EditedGestational age of 26 0/7 to 34 6/7 weeks
  • EditedNeed for CPAP >6 cms of water with FiO2 >35% at 6-84 hours OR need for CPAP £less than or equal to 6 cms and FiO2 £less than or equal to 35% but with increasing requirement of support**
Oct 27, 2026
Primary outcomes
2 edited
What changed in the outcomes
  • EditedComposite of all-cause mortality and/or any episode of culture-positive sepsis and/or severe sepsis* within the 1st 7 days after randomizationTime frame: Within 1st 7 days after randomization
  • ChangedBefore Need for intravenous antibiotics for ≥ 48 hours within the 1st 7 days after randomizationNow All-cause mortality within 7 days (i.e. 168 hours) after randomization, or cumulative intravenous antibiotic exposure exceeding 48 hours during those same 168 hours, summed across all antibiotic coursesTime frame: Within 1st 7 days after randomization
Oct 27, 2026
Documents
Oct 27, 2026
Secondary outcomes
10 edited, 7 time frame changed, 13 description edited, 1 more
What changed in the outcomes
  • EditedBlood cultureCulture-positive sepsis of any severity within 1st 7 days after randomizationTime frame: Within 1st 7 days after randomization
  • EditedComposite of mortality/blood culture positive sepsis/severe sepsis within 1st 72 hours after randomizationTime frame: Within first 72 hour after randomization
  • EditedComposite of mortality/blood culture positive sepsis/severe sepsis during hospital stayTime frame: During hospital stay upto 100 days after randomization → During hospital stay capped at 100 days
  • EditedComposite of mortality/blood culture positive sepsis/severe sepsis during 1st 30 days after randomizationof lifeTime frame: During 1st 30 days after randomization → During 1st 30 days of life
  • EditedSepsis-related mortality during hospital stay after randomizationTime frame: During hospital stay upto 100 days after randomization → During hospital stay capped at 100 days
  • EditedSepsis-related mortality during 1st 30 days after randomizationof lifeTime frame: During 1st 30 days after randomization → During 1st 30 days of life
  • EditedClinical sepsis within 1st 30 days after randomizationof lifeTime frame: During 1st 30 days after randomization → During 1st 30 days of life
  • EditedNeed for sepsis workup during 1st 30 days after randomizationof lifeTime frame: During 1st 30 days after randomization → During 1st 30 days of life
  • EditedAdverse effects until day 30 after randomizationof lifeTime frame: During 30 days after randomization → During 30 days of life
  • EditedSerious adverse effects until day 30 after randomizationof lifeTime frame: During 30 days after randomization → During 30 days of life
  • Time frameIndividual components of composite outcome during hospital stayDuring hospital stay upto 100 days after randomization → During hospital stay capped at 100 days
  • Time frameNecrotizing enterocolitis, stage II-III by modified Bell's staging criteria during hospital stayDuring hospital stay upto 100 days after randomization → During hospital stay capped at 100 days
  • Time frameIndividual components of composite outcome during 1st 30 daysDuring 1st 30 days after randomization → During 1st 30 days of life
  • Time frameNecrotizing enterocolitis, stage II-III by modified Bell's staging criteriaDuring 1st 30 days after randomization → During 1st 30 days of life
  • Time frameNeed for sepsis workup during hospital stayDuring hospital stay upto 100 days → During hospital stay capped at 100 days
  • Time frameCumulative duration of antibiotic therapy during hospital stayDuring hospital stay upto 100 days after randomization → During hospital stay capped at 100 days
  • Time frameDuration of hospitalizationUpto 100 days → Hospital stay capped at 100 days
  • DescriptionClinical sepsis during hospital stay: how it is measured was reworded
  • DescriptionClinical sepsis within 1st 72 hours after randomization: how it is measured was reworded
  • DescriptionClinical sepsis within 7 days after randomization: how it is measured was reworded
  • DescriptionEpisode of Probable EONS within 7 days after randomization: how it is measured was reworded
  • DescriptionEpisode of Probable EONS within 72 hours after randomization: how it is measured was reworded
  • DescriptionEpisode of asymptomatic proven EONS within 72 hours after randomization: how it is measured was reworded
  • DescriptionEpisode of severe sepsis within 1st 7 days after randomization: how it is measured was reworded
  • DescriptionIndividual components of composite outcome during 1st 30 days: how it is measured was reworded
  • DescriptionIndividual components of composite outcome during hospital stay: how it is measured was reworded
  • DescriptionIndividual components of composite outcome within 1st 72 hours after randomization: how it is measured was reworded
  • DescriptionNecrotizing enterocolitis, stage II-III by modified Bell's staging criteria: how it is measured was reworded
  • DescriptionNecrotizing enterocolitis, stage II-III by modified Bell's staging criteria during hospital stay: how it is measured was reworded
  • DescriptionSepsis-related mortality within 1st 72 hours after randomization: how it is measured was reworded
  • …and 1 more, on the record history on ClinicalTrials.gov ↗
Oct 27, 2026
Show all 1 update
  1. Oct 27, 2026
    Not yet recruiting→Recruiting
    Documents Study protocol ↗ posted · Statistical analysis plan ↗ posted
    9 sites added, 1 site removed
    Show 9 added (9 India)
    • Government medical College Chandigarh · Chandigarh, India
    • Post Graduate Institute of Medical Education and Research (PGIMER) · Chandigarh, India
    • Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences · Rohtak, India
    • IGICH bengaluru · Bengaluru, India
    • Government Medical College, Aurangabad · Aurangabad, India
    • King Edward Memorial Hospital · Mumbai, India
    • Lady Hardinge Medical College and Kalawati Saran Children's Hospital · New Delhi, India
    • IOG Chennai · Chennai, India
    • KGMU Lucknow · Lucknow, India
    Show 1 removed
    • Post Graduate Institute of Medical Education and Research (PGIMER) · Chandigarh, India
    Start date Apr 15, 2024→Jun 7, 2025 (now actual)
    Primary completion Apr 15, 2027→Jan 2028
    Study completion Apr 14, 2028→May 2028
    Eligibility Minimum age 0 Hours→4 Hours; 2 inclusion criteria edited
    What changed in the criteria
    Inclusion criteria
    • EditedGestational age of 26 0/7 to 34 6/7 weeks
    • EditedNeed for CPAP >6 cms of water with FiO2 >35% at 6-84 hours OR need for CPAP £less than or equal to 6 cms and FiO2 £less than or equal to 35% but with increasing requirement of support**
    Primary outcomes 2 edited
    What changed in the outcomes
    • EditedComposite of all-cause mortality and/or any episode of culture-positive sepsis and/or severe sepsis* within the 1st 7 days after randomizationTime frame: Within 1st 7 days after randomization
    • ChangedBefore Need for intravenous antibiotics for ≥ 48 hours within the 1st 7 days after randomizationNow All-cause mortality within 7 days (i.e. 168 hours) after randomization, or cumulative intravenous antibiotic exposure exceeding 48 hours during those same 168 hours, summed across all antibiotic coursesTime frame: Within 1st 7 days after randomization
    Secondary outcomes 10 edited, 7 time frame changed, 13 description edited, 1 more
    What changed in the outcomes
    • EditedBlood cultureCulture-positive sepsis of any severity within 1st 7 days after randomizationTime frame: Within 1st 7 days after randomization
    • EditedComposite of mortality/blood culture positive sepsis/severe sepsis within 1st 72 hours after randomizationTime frame: Within first 72 hour after randomization
    • EditedComposite of mortality/blood culture positive sepsis/severe sepsis during hospital stayTime frame: During hospital stay upto 100 days after randomization → During hospital stay capped at 100 days
    • EditedComposite of mortality/blood culture positive sepsis/severe sepsis during 1st 30 days after randomizationof lifeTime frame: During 1st 30 days after randomization → During 1st 30 days of life
    • EditedSepsis-related mortality during hospital stay after randomizationTime frame: During hospital stay upto 100 days after randomization → During hospital stay capped at 100 days
    • EditedSepsis-related mortality during 1st 30 days after randomizationof lifeTime frame: During 1st 30 days after randomization → During 1st 30 days of life
    • EditedClinical sepsis within 1st 30 days after randomizationof lifeTime frame: During 1st 30 days after randomization → During 1st 30 days of life
    • EditedNeed for sepsis workup during 1st 30 days after randomizationof lifeTime frame: During 1st 30 days after randomization → During 1st 30 days of life
    • EditedAdverse effects until day 30 after randomizationof lifeTime frame: During 30 days after randomization → During 30 days of life
    • EditedSerious adverse effects until day 30 after randomizationof lifeTime frame: During 30 days after randomization → During 30 days of life
    • Time frameIndividual components of composite outcome during hospital stayDuring hospital stay upto 100 days after randomization → During hospital stay capped at 100 days
    • Time frameNecrotizing enterocolitis, stage II-III by modified Bell's staging criteria during hospital stayDuring hospital stay upto 100 days after randomization → During hospital stay capped at 100 days
    • Time frameIndividual components of composite outcome during 1st 30 daysDuring 1st 30 days after randomization → During 1st 30 days of life
    • Time frameNecrotizing enterocolitis, stage II-III by modified Bell's staging criteriaDuring 1st 30 days after randomization → During 1st 30 days of life
    • Time frameNeed for sepsis workup during hospital stayDuring hospital stay upto 100 days → During hospital stay capped at 100 days
    • Time frameCumulative duration of antibiotic therapy during hospital stayDuring hospital stay upto 100 days after randomization → During hospital stay capped at 100 days
    • Time frameDuration of hospitalizationUpto 100 days → Hospital stay capped at 100 days
    • DescriptionClinical sepsis during hospital stay: how it is measured was reworded
    • DescriptionClinical sepsis within 1st 72 hours after randomization: how it is measured was reworded
    • DescriptionClinical sepsis within 7 days after randomization: how it is measured was reworded
    • DescriptionEpisode of Probable EONS within 7 days after randomization: how it is measured was reworded
    • DescriptionEpisode of Probable EONS within 72 hours after randomization: how it is measured was reworded
    • DescriptionEpisode of asymptomatic proven EONS within 72 hours after randomization: how it is measured was reworded
    • DescriptionEpisode of severe sepsis within 1st 7 days after randomization: how it is measured was reworded
    • DescriptionIndividual components of composite outcome during 1st 30 days: how it is measured was reworded
    • DescriptionIndividual components of composite outcome during hospital stay: how it is measured was reworded
    • DescriptionIndividual components of composite outcome within 1st 72 hours after randomization: how it is measured was reworded
    • DescriptionNecrotizing enterocolitis, stage II-III by modified Bell's staging criteria: how it is measured was reworded
    • DescriptionNecrotizing enterocolitis, stage II-III by modified Bell's staging criteria during hospital stay: how it is measured was reworded
    • DescriptionSepsis-related mortality within 1st 72 hours after randomization: how it is measured was reworded
    • …and 1 more, on the record history on ClinicalTrials.gov ↗
    + 7 other changes: index terms, identifiers, verification date, description, design details, arm descriptions and references

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06377397
Lead sponsor
Indian Council of Medical Research
Collaborators
Lady Hardinge Medical College, King George's Medical University, Indira Gandhi Institute of Child Health, Institute of Obstetrics and Gynecology, Government Medical College, Chandigarh, Pandit Bhagwat Dayal Sharma, PGIMS, Rohtak, Government Medical College, Aurangabad, King Edward Memorial Hospital, Mumbai
Responsible party
Sourabh Dutta (Professor, Post Graduate Institute of Medical Education and Research, Chandigarh) — Principal investigator
First posted
Apr 22, 2024
Start date
Jun 7, 2025
Primary completion
Jan 2028 (estimated)
Completion
May 2028 (estimated)
Last update
Oct 27, 2026

Study contacts

Sourabh Dutta, MD, Ph.D
Contact
sourabhdutta1@gmail.com
+91-1722755313
Sajan Saini, MD, DM
Contact
sajansaini1@gmail.com
+91-1722756264
Sourabh Dutta, MD, Ph.D
principal investigator · Post Graduate Institute of Medical Education and Research, Chandigarh

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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