Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
- Preterm infants born between 30 0/7 weeks to 34 6/7 weeks of gestation
- Non-vigorous at birth
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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)
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
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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