Actively Recruiting
Led by Nemours Children's Clinic · Updated on 2025-07-10
3442
Participants Needed
9
Research Sites
8 weeks
Total Duration
N
Nemours Children's Clinic
Lead Sponsor
S
Sharp HealthCare
Collaborating Sponsor
This research aims to compare the long-term neurodevelopmental outcomes of infants who were non-vigorous at birth and received either umbilical cord milking (UCM) or early cord clamping (ECC). It specifically evaluates survival and neurodevelopmental impairment at 22 to 26 months of age using standardized neurological and developmental assessment tools. The trial builds on the original CORDMILK study and focuses on infants born at term or late preterm in low-resource settings. The study involves two groups: one where the umbilical cord is milked by pushing blood toward the infant four times before clamping, a process lasting 10 to 15 seconds, and another where the cord is clamped immediately after delivery, within 60 seconds. This cluster randomized trial aims to assess the effects of these two different delivery room procedures on infant outcomes. Participants will be assessed at 22 to 26 months of age for neurodevelopmental outcomes, with earlier assessments at 10 to 14 months also included. Researchers will use standardized tools to measure neurological and developmental status. The study also monitors survival rates and follows infants over time to provide a comprehensive view of the effects of umbilical cord management on these vulnerable newborns.
CONDITIONS
Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries Developmental Follow Up
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - At delivery
At delivery, participants receive either Umbilical Cord Milking, where the umbilical cord is squeezed to push blood toward the infant before clamping, or Early Cord Clamping, where the cord is clamped immediately after delivery within 60 seconds.
Duration - Up to 26 months after birth
Participants are assessed for neurodevelopmental outcomes using standardized tools at 10 to 14 months and again at 22 to 26 months of age to evaluate survival and developmental impairments.
Visits at approximately 1 year and 2 years of age
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
Indira Gandhi Government Medical College & Hospital
Nagpur, Maharashtra, India, 440018
Actively Recruiting
3
Pimpri Chinchwad Municipal Corporation's Post-Graduate Institute, Yashwantrao Chavan Memorial Hospital
Pune, Maharashtra, India, 411018
Actively Recruiting
4
Government Medical College
Chandrapur, MS, India, 442401
Actively Recruiting
5
Daga Memorial Woman and Children Hospital
Nagpur, MS, India, 440002
Actively Recruiting
6
Government Medical College and Hospital
Nagpur, MS, India, 440009
Actively Recruiting
7
All India Institute of Medical Science
Nagpur, MS, India, 441108
Not Yet Recruiting
8
Mahatma Gandhi Institute of Medical Sciences/ Kasturba Hospital
Wardha, MS, India, 442102
Actively Recruiting
9
Sawai Man Singh (SMS) Medical College
Jaipur, Rajasthan, India, 302004
Actively Recruiting
Z
Zubair H Aghai, MD
A
Anup Katheria, MD
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
PREVENTION
Number of Arms
2
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S Yogeshkumar, Sunil S Vernekar, Sangappa M Dhaded...
https://pubmed.ncbi.nlm.nih.gov/41250198