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Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries Developmental Follow Up

NCT03682042 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3442

Last updated 2025-07-10

No results posted yet for this study

Summary

An extension of the CORDMILK trial, the CORDMILK follow-up trial will evaluate the neurodevelopmental outcomes at 22-26 months age of term/late preterm infants who were non-vigorous at birth and received umbilical cord milking (UCM) or early cord clamping (ECC).

Conditions

  • Hypoxic-Ischemic Encephalopathy
  • Birth Asphyxia

Interventions

OTHER

Umbilical 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 10-15 seconds.

Sponsors & Collaborators

  • Sharp HealthCare

    collaborator OTHER

  • Thomas Jefferson University

    collaborator OTHER

  • University of California, San Diego

    collaborator OTHER

  • St. Louis University

    collaborator OTHER

  • KLE Academy of Higher Education and Research (Deemed- to- be-University), Jawaharlal Nehru Medical College (JNMC), Belagavi, India

    collaborator UNKNOWN

  • Government Medical College, Nagpur

    collaborator INDUSTRY

  • Daga Memorial Maternity and Children's Hospital, Nagpur, India

    collaborator UNKNOWN

  • Mahatma Gandhi Institute of Medical Sciences/ Kasturba Hospital, Wardha, India

    collaborator UNKNOWN

  • Karnataka Institute of Medical Sciences, Hubbali, India

    collaborator UNKNOWN

  • All India Institute of Medical Sciences

    collaborator OTHER

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Indira Gandhi Government Medical College & Hospital, Nagpur, India

    collaborator UNKNOWN

  • Pimpri Chinchwad Municipal Corporation's Post-Graduate Institute, Yashwantrao Chavan Memorial Hospital, Pune, India

    collaborator UNKNOWN

  • Nemours Children's Clinic

    lead OTHER

Principal Investigators

  • Zubair Aghai, MD · Nemours Children's Clinic

  • Anup Katheria, MD · Sharp Mary Birch Hospital for Women & Newborns

  • Sangappa Dhaded · KLE Academy of Higher Education and Research

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
22 Months
Max Age
26 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-17
Primary Completion
2027-08-30
Completion
2027-10-30

Countries

  • India

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03682042 on ClinicalTrials.gov