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RecruitingNCT06240715CORDMILK-PTUpdated Jul 13, 2026

Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries- PreTerm

An interventional study of Umbilical cord milking in Preterm and Infant Death, sponsored by Nemours Children's Clinic. Recruiting at 9 sites in India. Open to participants aged 0 Minutes to 10 Minutes. Per ClinicalTrials.gov, last updated 2026-07-13.

Sponsored by Nemours Children's Clinic · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
800
Allocation
Randomized
Ages
0 Minutes to 10 Minutes
Sex
All
01

Study summary

The goal of this multicenter, cluster-randomized, crossover trial is to determine if umbilical cord milking compared to early cord clamping will reduce in-hospital mortality in non-vigorous preterm infants born between 30 weeks and 34 weeks of gestation.

Read the detailed description

Background: Prematurity is the leading cause of death in children younger than 5 years of age. Worldwide, 15 million infants are born premature, and India alone contributes to quarter of them. Approximately 1 million children die each year due to complications of prematurity.

Delayed cord clamping (DCC), one of the methods of transfer of placental blood to neonates (placental transfusion) immediately after birth reduce mortality by 30% in premature infants. But DCC is not recommended in neonates who require immediate resuscitation. Umbilical cord milking (UCM) is an option for placental transfusion in preterm infants who require immediate resuscitation but not currently recommended due to lack of randomized clinical trials.

HYPOTHESIS: UCM will reduce the in-hospital mortality in non-vigorous preterm infants born between 30 weeks to 34 weeks of gestation compared to early cord clamping.

METHODS: This multicenter cluster crossover randomized trial will enroll approximately 800 preterm infants to early cord clamping or milking the intact cord 4 times prior to clamping.

IMPACT: If investigators find that UCM is beneficial, this simple, low-tech, no cost intervention can be used in preventing deaths in preterm infants. This trial will potentially provide evidence to support a change in guidelines making UCM part of standard practice worldwide for preterm infants who require immediate resuscitation.

02

Conditions studied

  • Preterm
  • Infant Death

Keywords

  • Preterm
  • Umbilical cord milking
  • Placental transfusion
03

Who can participate

Ages eligible
0 Minutes to 10 Minutes
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Preterm infants born between 30 0/7 weeks to 34 6/7 weeks of gestation
  • Non-vigorous at birth

Exclusion criteria

Exclusion Criteria:

  • Infants with congenital malformation
  • Major chromosomal abnormalities
  • Complete placental abruption/cutting through the placenta at the time of delivery
  • Cord conditions (umbilical knots, inadequate cord length, cord rupture, non-reducible nuchal cord)
  • Mono-chorionic twins,
  • Twins with no information on amnion/chorion
  • Multiple gestation >2
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
800 participants (estimated)

Study arms

  • Active comparator
    Umbilical Cord Milking

    The delivering practitioner will place the newborn below the level of the incision (at the edge of the table) at C/S and a second team member will milk the cord four times. For vaginal delivery, the delivering obstetrician, midwife or perinatal provider will hold the infant against their body or place the infant on the mother's abdomen and the cord will be milked either four times by the obstetrical provider or by a second team member. For the cord milking procedure, the obstetrical provider will milk 20-30 centimeters length of the umbilical cord over two seconds, repeating three additional times as described previously. This time is not significantly different from the time for early cord clamping (ECC).

    Procedure: Umbilical cord milking

  • No intervention
    Early Cord Clamping

    Umbilical cord will be clamped immediately after birth (within 60 seconds)

Interventions

  • ProcedureUmbilical cord milking

    At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before the cord is clamped. This procedure infuses a placental transfusion of blood into the infant and can be done in 1--15 seconds.

    Also known as: UCM

05

What researchers measure

Primary outcomes

  1. In-hospital mortality

    Death of a baby during birth hospitalization

    Time frame: From date of birth until the date of discharge from the hospital or date of death from any cause, whichever come first, assessed up to 12 weeks

Secondary outcomes

  1. Hemoglobin at or after 24 hours

    Hb levels

    Time frame: Days 1-7

  2. Early and late onset culture positive sepsis

    Number of infants with early onset or late onset sepsis

    Time frame: From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.

  3. Any intraventricular hemorrhage (IVH) and severe IVH (grade 3 or 4)

    Number of infants with any IVH or severe IVH

    Time frame: From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.

  4. Need for blood transfusion

    Number of infants received blood transfusion

    Time frame: From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.

  5. Moderate to severe hypoxemic ischemic encephalopathy

    Number of infants with moderate to severe hypoxemic ischemic encephalopathy

    Time frame: From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.

  6. Necrotizing enterocolitis (Bell's stage 2 or higher)

    Number of infants with necrotizing enterocolitis (Bell's stage 2 or higher)

    Time frame: From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.

  7. Need for medications for hypotension

    Number of infants needed medications for hypotension

    Time frame: From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.

  8. Need for phototherapy for jaundice

    Number of infants needed phototherapy for jaundice

    Time frame: From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.

  9. Retinopathy of prematurity (ROP) requiring intervention

    Number of infants with ROP that required intervention

    Time frame: From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.

  10. Length of hospitalization

    Number of days infants stayed in hospital

    Time frame: From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.

06

Study locations

3 of 9 sites recruiting
  • KLE Academy of Higher Education and Research (Deemed-to-be-University) Jawaharlal Nehru Medical College
    Belagavi, Karnataka 590010, India
    • Sangappa Dhaded, MD · Contact · drdhadedsm@gmail.com · +91 98442 32586
    • Shivaprasad Goudar, MD · Sub investigator
    Not yet recruiting
  • Government Medical College
    Chandrapur, Maharashtra 442401, India
    • Milind Kamble, MD · Contact · mkamble1732@ymail.com
    • Milind Kamble, MD · Principal investigator
    • Deepti Shrirame, MD · Principal investigator
    Not yet recruiting
  • Indira Gandhi Government Medical College & Hospital
    Nagpur, Maharashtra 440018, India
    • Alka Patankar, MD · Contact · alkajatkar@gmail.com
    • Milind Suryavanshi, MD · Principal investigator
    • Alka Patankar, MD · Principal investigator
    Not yet recruiting
  • Yashwantrao Chavan Memorial Hospital
    Pune, Maharashtra 411018, India
    • Mahesh Asalkar, MD · Contact · mahesh@asalkarclinic.com
    • Mahesh Asalkar, MD · Principal investigator
    • Deepali Ambike, MD · Principal investigator
    • Rajesh Kulkarni, MD · Sub investigator
    • Hemraj Narkheded, MD · Sub investigator
    • Sandhya Haribhakta, MD · Sub investigator
    Not yet recruiting
  • Daga Memorial Woman and Children Hospital
    Nagpur, MS 440002, India
    • Seema Parvekar, MD · Contact · seemaparvekar@gmail.com · +91-98909 87153
    • Vineeta Jain, MD · Principal investigator
    • Seema Parvekar, MD · Principal investigator
    Recruiting
  • Government Medical College and Hospital
    Nagpur, MS 440009, India
    • Manish Tiwari, MD · Contact · manishtiwari.peds@rediffmail.com · +91 9552526538
    • Manoj Bhatnagar, MD · Principal investigator
    • Manjushri Waikar, MD · Principal investigator
    • Nidhi Nashine · Sub investigator
    Not yet recruiting
  • Mahatma Gandhi Institute of Medical Sciences/ Kasturba Hospital
    Wardha, MS 442102, India
    • Manish Jain, MD · Contact · manish@mgims.ac.in · +91-98226 95195
    • Manish Jain, MD · Principal investigator
    • Shuchi Jain, MD · Principal investigator
    Not yet recruiting
  • Sawai Man Singh Medical College
    Jaipur, Rajasthan 302004, India
    • Seema Mehta, MD · Contact
    • Seema Mehta, MD · Principal investigator
    • Asha Varma, MD · Principal investigator
    • Sunil Gothwal, MD · Principal investigator
    Recruiting
  • Osmania Medical College, Niloufer Hospital
    Hyderabad, Telangana 500004, India
    • D Suchitra, MD · Contact
    Recruiting
07

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06240715
Lead sponsor
Nemours Children's Clinic
Collaborators
Thrasher Research Fund, Thomas Jefferson University, Sharp HealthCare, Jawaharlal Nehru Medical College, Daga Memorial Maternity and Children's Hospital, Nagpur, India, Mahatma Gandhi Institute of Medical Sciences, Indira Gandhi Government Medical College & Hospital, Nagpur, India, Pimpri Chinchwad Municipal Corporation's Post-Graduate Institute, Yashwantrao Chavan Memorial Hospital, Pune, India, Government Medical College, Nagpur, Government Medical College, Chandrapur, India, Osmania Medical College, Niloufer Hospital, Hyderabad, India
Responsible party
Zubair Aghai (Professor of Pediatrics, Nemours Children's Clinic) — Principal investigator
First posted
Feb 5, 2024
Start date
Jul 1, 2024
Primary completion
Nov 30, 2026 (estimated)
Completion
Mar 30, 2027 (estimated)
Last update
Jul 13, 2026

Study contacts

Zubair H Aghai, MD
Contact
zaghai@nemours.org
215 955 6523

Oversight

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

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