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CompletedNCT03273764Updated Sep 12, 2017

Clinical RD (Respiratory Distress) Score for Objective Decision Making for Surfactant Therapy

An observational study in Respiratory Distress Syndrome in Premature Infant, Surfactant and CPAP, sponsored by Lady Hardinge Medical College. Completed at 1 site in India. Open to participants aged 26 Weeks to 34 Weeks. Per ClinicalTrials.gov, last updated 2017-09-12.

Sponsored by Lady Hardinge Medical College · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
209
Ages
26 Weeks to 34 Weeks
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 26 studies in Premature Birth with a site in India — 4 open to participants now, 5 under way, 2 of them phase 3. Premature Birth · India.

Started
2015
the only one that year
Observational
6 of 26
1 open now
Registered
13th of 26
by date
Lead sponsor
4 of 26
Lady Hardinge Medical College

Among the 26 studies in Premature Birth with a site in India, this one is the only one that started in 2015, is one of 6 observational ones, and was the 13th registered.

Premature Birth

2,553 studies on the registry are indexed under Premature Birth; 502 are open to participants now.

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Open to participants now

4 of the 26 studies in Premature Birth with a site in India are open now. Recruiting first, the newest first:

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A study can be open while its sites in India have not opened yet or have stopped. Only those recruiting at a site in India →

Who these studies take

Of the 315 Premature Birth studies recruiting now, 88 (28%) set no upper age limit and 223 (71%) stop at 75 or younger; 241 take children under 18; 105 take healthy volunteers.

This study: 26 Weeks to 34 Weeks · all sexes · no healthy volunteers.

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02

Study summary

To develop a comprehensive 'Clinical RD score' for decision making for administration of Surfactant in respiratory distress syndrome in preterm infants with gestation of 26 0/7 - 34 6/7 weeks and to assess the validity of this 'clinical RD score' on a different subgroup of patients with similar gestational age.

Read the detailed description

Respiratory distress syndrome, also known as hyaline membrane disease, occurs almost exclusively in premature infants. The incidence and severity of respiratory distress syndrome are inversely related to the gestational age of the newborn infant. The incidence of RDS is around 60 - 80% among infants \< 28 weeks, 30-40% between 28-34 weeks, less than 5% at 34 weeks and is rarely seen among those > 37 weeks.

The availability of continuous positive airway pressure (CPAP) and natural surfactant have revolutionised the management of RDS. In 1967, Gregory et al. reported the value of application of continuous positive airway pressure in the management of RDS. Successful surfactant replacement therapy in RDS was reported by Fujiwara et al. Besides the use of Continuous positive airway pressure and surfactant replacement, the other advances include: Use of antenatal steroids to enhance pulmonary maturity, appropriate resuscitation and immediate use of CPAP for alveolar recruitment, Use of gentler modes of ventilation like patient triggered ventilation, Supportive therapies, such as the diagnosis and management of patent ductus arteriosus (PDA), fluid and electrolyte management, trophic feeding and nutrition.

The use of CPAP applied to the alveoli has been shown to stabilise and improve respiratory distress in preterm babies. It preserves the action of endogenous surfactant and may also obviate the need for surfactant in a substantial number of cases. CPAP is cost effective and more patient friendly than mechanical ventilation. Availability of CPAP even at the district level Special Newborn Care Unit (SNCU) in various states across the country make it an ideal candidate for respiratory support in the high risk population.

In addition to optimal respiratory support in the form of continuous positive airway pressure (CPAP) or mechanical ventilation and good supportive care, surfactant replacement therapy (SRT) forms the mainstay in the management of RDS. Since the report by Fujiwara in 1980 of the first successful use of SRT, numerous randomized controlled trials (RCTs) and their meta-analyses have established its efficacy in reducing mortality and air leak syndromes in RDS. Almost all the trials evaluating the role of SRT were conducted in high-income countries. Not surprisingly, SRT is the standard of care in neonates with RDS in these countries.

The population in low and middle income countries (LMIC) like India may differ significantly from the western world. But whether the evidence from these high income countries can be extrapolated to LMICs, still remains questionable. High cost of surfactant therapy, issue regarding regular supply of the drug, lack of skilled personnel, poor antenatal steroid coverage of mothers with preterm labour, higher incidence of perinatal hypoxia/ischemia and infections all complicate the clinical course of RDS. The paucity of evidence for efficacy and/ or safety of SRT in these settings further add to the complexity.

Continuous positive airway pressure (CPAP) remains as the first line of respiratory support in spontaneously breathing infants with RDS and surfactant is administered if required. The beneficial effects of surfactant are more pronounced when the therapy is started earlier. In most of the units across the country, the decision to administer surfactant to such babies managed on CPAP is clinician oriented and hence remains highly subjective. There are no objective criteria to decide for administration of surfactant to infants who are initially managed with CPAP. The current study was planned keeping in mind the beneficial effects of early CPAP and early surfactant, with the aim of developing an objective scoring system, which would guide the clinician in decision making for administration of surfactant to infants with RDS who are already being managed with CPAP.

03

Conditions studied

  • Respiratory Distress Syndrome in Premature Infant
  • Surfactant
  • CPAP

Keywords

  • Preterm, RDS, Surfactant, CPAP
04

Who can participate

Ages eligible
26 Weeks to 34 Weeks
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Preterm neonates between 26 weeks to 34 weeks of gestation with a clinical diagnosis of RDS.

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

  • Neonates between 26 0/7-34 6/7 weeks of gestation who were delivered in the hospital with clinical diagnosis of respiratory distress syndrome were eligible for inclusion for the study.

Exclusion criteria

Exclusion Criteria:

  • Major congenital malformation
  • Antenatally diagnosed congenital heart disease in fetus.
  • Hydrops fetalis
  • Massive Pulmonary hemorrhage prior to enrolment
  • Shock requiring vasopressor support prior to enrolment
  • Non availability of CPAP/ventilator in the unit.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
209 participants (actual)
Patient registry
No

Groups and cohorts

  • Preterm neonates with RDS

    Singleton Preterm neonates with gestational age between 26 completed weeks to 34 completed weeks with clinical diagnosis of RDS without any major congenital anomalies.

06

What researchers measure

Primary outcomes

  1. Developement of a clinical RD score for decision making for administration of surfactant in preterm babies with RDS

    The study will be conducted in 2 parts.Written informed consent will be obtained from one of the parents of the eligible neonates. The demographic and clinical data related to all putative risk factors will be recorded at the time of enrollment from all eligible neonates in the age group of 26-34 weeks with clinical features suggestive of RDS/HMD (Hyaline Membrane Disease). The putative risk factors which could potentially increase the chances of surfactant administration to the infant will be documented and will be analysed through logistic regression analysis and clinical RD score will be developed. The score developed in the first part of the study will be applied on a different population of preterm infants with RDS with similar gestational age.

    Time frame: January 2015 to September 2016

07

Study locations

1 site
  • Lady Hardinge Medical college
    New Delhi, Delhi 110001, India
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2015 to primary completion in Sep 2016, 20 months.

Of 372 non-industry observational studies under Premature Birth, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 63. This study's 20 months is below that.

Counting every sponsor, half of 387 studies reached it within 35 months; a quarter within 18 and three quarters within 61.

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

Registered
Sep 4, 2017
First posted
Sep 6, 2017
StartActual
Jan 1, 2015
Primary completionActual
Sep 30, 2016
CompletionActual
Dec 23, 2016
Last update
Sep 12, 2017
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.
No changes since tracking began. The registry record was last updated on Sep 12, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03273764
Lead sponsor
Lady Hardinge Medical College
Responsible party
Sushma Nangia, M.D. (Director professor and head of department, Lady Hardinge Medical College) — Principal investigator
First posted
Sep 6, 2017
Start date
Jan 1, 2015
Primary completion
Sep 30, 2016
Completion
Dec 23, 2016
Last update
Sep 12, 2017

Study contacts

Sushma Nangia, MBBS, MD, DM
principal investigator · Kalawati Saran Chindren Hospital and Lady Hardinge Medical College
Debasish Nanda, MBBS, MD
principal investigator · Kalawati Saran Chindren Hospital and Lady Hardinge Medical College

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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