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

NCT ID: NCT03682042

Last Updated: 2025-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

3442 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-17

Study Completion Date

2027-10-30

Brief Summary

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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).

Detailed Description

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The CORDMILK Follow-up trial will examine the difference in survival and neurodevelopmental impairment of infants who were non-vigorous at birth and enrolled in the CORDMILK trial. The difference in survival and neurodevelopmental impairment in infants who received UCM and ECC will be assessed using standardized neurological and developmental assessment tools at 22-26 months of age.

Conditions

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Hypoxic-Ischemic Encephalopathy Birth Asphyxia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
Neurodevelopmental providers will be blinded to the randomization of the toddler during the examination.

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Umbilical Cord Milking

Intervention Type 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.

Early Cord Clamping

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Enrolled in CORDMILK trial
* Non-vigorous at birth

Exclusion Criteria

* None
Minimum Eligible Age

22 Months

Maximum Eligible Age

26 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sharp HealthCare

OTHER

Sponsor Role collaborator

Thomas Jefferson University

OTHER

Sponsor Role collaborator

University of California, San Diego

OTHER

Sponsor Role collaborator

St. Louis University

OTHER

Sponsor Role collaborator

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

UNKNOWN

Sponsor Role collaborator

Government Medical College, Nagpur

INDUSTRY

Sponsor Role collaborator

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

UNKNOWN

Sponsor Role collaborator

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

UNKNOWN

Sponsor Role collaborator

Karnataka Institute of Medical Sciences, Hubbali, India

UNKNOWN

Sponsor Role collaborator

All India Institute of Medical Sciences

OTHER

Sponsor Role collaborator

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

NIH

Sponsor Role collaborator

Indira Gandhi Government Medical College & Hospital, Nagpur, India

UNKNOWN

Sponsor Role collaborator

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

UNKNOWN

Sponsor Role collaborator

Nemours Children's Clinic

OTHER

Sponsor Role lead

Responsible Party

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Zubair Aghai

Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zubair Aghai, MD

Role: PRINCIPAL_INVESTIGATOR

Nemours Children's Clinic

Anup Katheria, MD

Role: PRINCIPAL_INVESTIGATOR

Sharp Mary Birch Hospital for Women & Newborns

Sangappa Dhaded

Role: PRINCIPAL_INVESTIGATOR

KLE Academy of Higher Education and Research

Locations

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

Belagavi, Karnataka, India

Site Status NOT_YET_RECRUITING

Indira Gandhi Government Medical College & Hospital

Nagpur, Maharashtra, India

Site Status RECRUITING

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

Pune, Maharashtra, India

Site Status RECRUITING

Government Medical College

Chandrapur, MS, India

Site Status RECRUITING

Daga Memorial Woman and Children Hospital

Nagpur, MS, India

Site Status RECRUITING

Government Medical College and Hospital

Nagpur, MS, India

Site Status RECRUITING

All India Institute of Medical Science

Nagpur, MS, India

Site Status NOT_YET_RECRUITING

Mahatma Gandhi Institute of Medical Sciences/ Kasturba Hospital

Wardha, MS, India

Site Status RECRUITING

Sawai Man Singh (SMS) Medical College

Jaipur, Rajasthan, India

Site Status RECRUITING

Countries

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India

Central Contacts

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Zubair H Aghai, MD

Role: CONTACT

215 955 6523

Anup Katheria, MD

Role: CONTACT

858 839 4170

Facility Contacts

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Sangappa Dhaded, MD

Role: primary

+91 98442 32586

Milind Suryavanshi, MD

Role: primary

Deepali Ambike, MD

Role: primary

Milind Kamble, MD

Role: primary

Seema Parvekar, MD

Role: primary

+91-98909 87153

Manoj Bhatanagar, MD

Role: primary

+91-98812 37232

Meenakshi Girish, MD

Role: primary

+91-94221 09733

Manish Jain, MD

Role: primary

+91-98226 95195

Seema Mehta, MD

Role: primary

Other Identifiers

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R01HD102967

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CORDMILK FU

Identifier Type: -

Identifier Source: org_study_id

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