Actively Recruiting

Phase Not Applicable
Age: 0Minutes - 10Minutes
All Genders
ID06240715

A Cluster Randomized Clinical Trial of Umbilical Cord Milking Compared to Early Cord Clamping in Preterm Infants Who Are Non-vigorous at Birth

Led by Nemours Children's Clinic · Updated on 2025-07-11

800

Participants Needed

9

Research Sites

26 weeks

Total Duration

On this page

Sponsors

N

Nemours Children's Clinic

Lead Sponsor

T

Thrasher Research Fund

Collaborating Sponsor

AI-Summary

What this Trial Is About

Prematurity is a leading cause of death in children under 5 years old, with about 15 million infants born premature worldwide each year. This trial is studying whether umbilical cord milking, compared to early cord clamping, can reduce in-hospital death rates in non-vigorous preterm infants born between 30 and 34 weeks of gestation. The research aims to provide evidence to support changes in delivery room practices to improve survival of these infants. The study compares two approaches at birth: umbilical cord milking and early cord clamping. In cord milking, the healthcare provider will milk the umbilical cord four times to push blood toward the infant before clamping, which takes about the same time as early clamping. The newborn is placed below the incision level during cesarean or held close after vaginal delivery while the cord is milked. Early cord clamping involves clamping the cord immediately within 60 seconds after birth. About 800 preterm infants will be randomly assigned to one of these two groups. Participants will be monitored from birth until hospital discharge or up to 12 weeks. Researchers will measure outcomes including in-hospital mortality, hemoglobin levels, infections, brain hemorrhage, need for blood transfusions and medications, jaundice treatment, retinopathy, and length of hospital stay. This study includes multiple centers and aims to gather detailed clinical data to assess the impact of the cord milking procedure.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 0Minutes - 10Minutes
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Preterm infants born between 30 0/7 weeks to 34 6/7 weeks of gestation
  • Non-vigorous at birth
Not Eligible

You will not qualify if you...

  • Infants with congenital malformation
  • Major chromosomal abnormalities
  • Complete placental abruption or cutting through the placenta at delivery
  • Umbilical cord conditions such as knots, inadequate length, rupture, or non-reducible nuchal cord
  • Mono-chorionic twins
  • Twins with no information on amnion or chorion
  • Multiple gestation with more than two babies

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - At birth

Participants receive either umbilical cord milking or early cord clamping immediately after birth as part of delivery-room procedures.

1 visit (at delivery)

Monitoring

Duration - Up to 12 weeks

Participants are monitored in the hospital from birth until discharge or up to 12 weeks to assess outcomes related to prematurity and the intervention.

Multiple hospital visits during stay

Trial Site Locations

Total: 9 locations

1

KLE Academy of Higher Education and Research (Deemed-to-be-University) Jawaharlal Nehru Medical College

Belagavi, Karnataka, India, 590010

Not Yet Recruiting

2

Government Medical College

Chandrapur, Maharashtra, India, 442401

Not Yet Recruiting

3

Indira Gandhi Government Medical College & Hospital

Nagpur, Maharashtra, India, 440018

Not Yet Recruiting

4

Yashwantrao Chavan Memorial Hospital

Pune, Maharashtra, India, 411018

Not Yet Recruiting

5

Daga Memorial Woman and Children Hospital

Nagpur, MS, India, 440002

Actively Recruiting

6

Government Medical College and Hospital

Nagpur, MS, India, 440009

Not Yet Recruiting

7

Mahatma Gandhi Institute of Medical Sciences/ Kasturba Hospital

Wardha, MS, India, 442102

Not Yet Recruiting

8

Sawai Man Singh Medical College

Jaipur, Rajasthan, India, 302004

Actively Recruiting

9

Osmania Medical College, Niloufer Hospital

Hyderabad, Telangana, India, 500004

Actively Recruiting

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Research Team

Z

Zubair H Aghai, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

PREVENTION

Number of Arms

2

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