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

Summary

The investigators will conduct a study on non-vigorous infants at birth to determine if umbilical cord milking (UCM) results in lower rate of moderate to severe hypoxic ischemic encephalopathy (HIE) or death than early clamping and for infants who are non-vigorous at birth and need immediate resuscitation.

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 1--15 seconds.

Sponsors & Collaborators

• Sharp HealthCare

  collaborator OTHER

• Thomas Jefferson University

  collaborator OTHER

• University of San Diego

  collaborator OTHER

• St. Louis University

  collaborator OTHER

• Jawaharlal Nehru Medical College

  collaborator OTHER

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

  collaborator UNKNOWN

• Mahatma Gandhi Institue of Medical Sciences, Wardha, India

  collaborator UNKNOWN

• Karnataka Institue of Medical Sciences, Hubbali, India

  collaborator UNKNOWN

• Jawaharlal Institute of Postgraduate Medical Education & Research

  collaborator OTHER_GOV

• 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

• Government Medical College, Nagpur

  collaborator INDUSTRY

• Nemours Children's Clinic

  lead OTHER

Principal Investigators

• Zubair H Aghai, MD · Nemours Children's Clinic

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

• Sangappa Dhaded, MD · KLE Academy of Higher Education and Research

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

35 Weeks

Max Age

42 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-10-17

Primary Completion

2025-09-01

Completion

2026-06-28

Countries

• India

Study Locations