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

NCT03682042 | Recruiting DMC

• 2 other identifiers: CORDMILK FUR01HD102967
• Study Type: interventional
• Target: 3,442
• Locations: 1 country
• Sites: 9

Brief 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

Keywords

Placental transfusion

Outcome Measures

Primary Outcomes (1)

• Neurodevelopmental Outcome at 2 Years of Age

  Neurodevelopmental assessment will be performed by the trained and experienced examiner who will be blinded to the interventions. Severe neurodevelopmental impairment will be defined having at least one of the following: BSID (IV) composite cognitive score \<70, GMFCS level 3-5, blindness (vision \<20/200), or hearing impairment requiring hearing aids/cochlear implant. Moderate neurodevelopmental impairment will be defined as having a cognitive composite score 70-84, GMFCS level 2, unilateral blindness (vision/20/200 in only one eye), or hearing impairment with no amplification/cochlear implant.

  22-26 months

Secondary Outcomes (1)

• Neurodevelopmental Outcome at 1 Year of Age

  10-14 months

Study Arms (2)

Umbilical Cord Milking

ACTIVE COMPARATOR

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.

Other: Umbilical Cord Milking

Early Cord Clamping

NO INTERVENTION

The umbilical cord is clamped immediately after the delivery (within 60 seconds).

Interventions

Umbilical Cord Milking OTHER

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.

Umbilical Cord Milking

Eligibility Criteria

• Age: 22 Months - 26 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Enrolled in CORDMILK trial
• Non-vigorous at birth

You may not qualify if:

• None

Sponsors & Collaborators

• Nemours Children's Clinic: lead
• Sharp HealthCare: collaborator
• Thomas Jefferson University: collaborator
• University of California, San Diego: collaborator
• St. Louis University: collaborator
• KLE Academy of Higher Education and Research (Deemed- to- be-University), Jawaharlal Nehru Medical College (JNMC), Belagavi, India: collaborator
• Government Medical College, Nagpur: collaborator
• Daga Memorial Maternity and Children's Hospital, Nagpur, India: collaborator
• Mahatma Gandhi Institute of Medical Sciences/ Kasturba Hospital, Wardha, India: collaborator
• Karnataka Institute of Medical Sciences, Hubbali, India: collaborator
• All India Institute of Medical Sciences: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Indira Gandhi Government Medical College & Hospital, Nagpur, India: collaborator
• Pimpri Chinchwad Municipal Corporation's Post-Graduate Institute, Yashwantrao Chavan Memorial Hospital, Pune, India: collaborator

Study Sites (9)

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

Belagavi, Karnataka, 590010, India

NOT YET RECRUITING

Indira Gandhi Government Medical College & Hospital

Nagpur, Maharashtra, 440018, India

RECRUITING

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

Pune, Maharashtra, 411018, India

RECRUITING

Government Medical College

Chandrapur, MS, 442401, India

RECRUITING

Daga Memorial Woman and Children Hospital

Nagpur, MS, 440002, India

RECRUITING

Government Medical College and Hospital

Nagpur, MS, 440009, India

RECRUITING

All India Institute of Medical Science

Nagpur, MS, 441108, India

NOT YET RECRUITING

Mahatma Gandhi Institute of Medical Sciences/ Kasturba Hospital

Wardha, MS, 442102, India

RECRUITING

Sawai Man Singh (SMS) Medical College

Jaipur, Rajasthan, 302004, India

RECRUITING

Related Publications (1)

• Yogeshkumar S, Vernekar SS, Dhaded SM, Talekar K, Leiby BE, Hartman R, Vaucher Y, Chouthai N, Girish M, Jain M, Jain S, Parvekar S, Jain V, Patankar A, Suryawanshi M, Tiwari M, Waikar M, Nashine N, Ambike D, Asalkar M, Kulkarni R, Haribhaktha S, Narkhede H, Chaudhari S, Kamble M, Shrirame D, Falke B, Mehta S, Verma A, Gothwal S, Goudar SS, Derman R, Katheria A, Aghai ZH. CORDMILK: Umbilical Cord Milking versus Early Cord Clamping on short-and long-term outcomes in neonates who are non-vigorous at birth-study protocol of a multi-center, cluster-randomized, crossover-controlled trial. Trials. 2025 Nov 17;26(1):509. doi: 10.1186/s13063-025-09197-8.

  PMID: 41250198 DERIVED

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain; Asphyxia Neonatorum; Fetofetal Transfusion

Interventions

Umbilical Cord Clamping

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Anemia, Neonatal; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Zubair Aghai, MD

  Nemours Children's Clinic

  PRINCIPAL INVESTIGATOR

• Anup Katheria, MD

  Sharp Mary Birch Hospital for Women & Newborns

  PRINCIPAL INVESTIGATOR

• Sangappa Dhaded

  KLE Academy of Higher Education and Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zubair H Aghai, MD

CONTACT

215 955 6523; zaghai@nemours.org

Anup Katheria, MD

CONTACT

858 839 4170; anup.katheria@sharp.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Neurodevelopmental providers will be blinded to the randomization of the toddler during the examination.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Model Details: Neurodevelopmental assessments will be done at 2 years of age (22-26 months) for subjects who were randomized to receive either early cord clamping or umbilical cord milking as part of the CORDMILK trial.

Study Record Dates

• First Submitted: September 20, 2018
• First Posted: September 24, 2018
• Study Start: October 17, 2022
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): October 30, 2027
• Last Updated: July 10, 2025

Record last verified: 2025-07

Locations

IN (9)