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Delayed Cord Clamping in VLBW Infants

NCT01222364 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2017-09-26

No results posted yet for this study

Summary

This study tested the feasibility of conducting a randomized controlled trial to vary the timing that doctors clamp the umbilical cord after birth in extremely low birthweight infants. The study also tested whether delaying cord clamping by 30-35 seconds and holding the newborn approximately 10 inches below the birth canal would result in increased hematocrit at 4 hours of age.

Conditions

  • Infant, Newborn
  • Infant, Low Birth Weight
  • Infant, Small for Gestational Age
  • Infant, Premature

Interventions

PROCEDURE

Standard Cord Clamping

Immediate clamping (\<5 seconds) of the umbilical cord after delivery.

PROCEDURE

Delayed Cord Clamping

Clamping of the umbilical cord at 30-45 seconds after birth.

Sponsors & Collaborators

  • National Center for Research Resources (NCRR)

    collaborator NIH

  • NICHD Neonatal Research Network

    lead NETWORK

Principal Investigators

  • William Oh, MD · Brown University, Women & Infants Hospital of Rhode Island

  • Avroy A. Fanaroff, MD · Case Western Reserve University, Rainbow Babies and Children's Hospital

  • Edward F. Donovan, MD · Children's Hospital Medical Center, Cincinnati

  • Waldemar A. Carlo, MD · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
1 Minute
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2000-06-30
Primary Completion
2000-12-31
Completion
2000-12-31

Countries

  • United States

Study Locations

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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 NCT01222364 on ClinicalTrials.gov