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Protective Effects of Delayed Cord Clamping in Very Low Birth Weight (VLBW) Infants

NCT00818220 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 211

Last updated 2015-05-27

No results posted yet for this study

Summary

The purpose of this study is to determine whether the intervention of delaying cord clamping for 30 to 45 seconds followed by one milking of the cord while simultaneously lowering the VLBW infants below the introitus will result in less bleeding in the brain and fewer infections while in the Neonatal Intensive Care Unit (NICU) and better motor skills at 7 months corrected age. The investigators will attempt to identify the mechanisms of effect through measurement of biologic markers.

Conditions

  • Intraventricular Hemorrhage
  • Sepsis

Interventions

PROCEDURE

delayed umbilical cord clamping

at birth, the clamping of the umbilical cord will be delayed 30 to 45 seconds while the child is held lower than the placenta. At the end of the time, the cord is milked once and the cord is clamped. If the obstetrician feels he cannot delay the cord clamping, then the cord can be milked 2 to 3 times.

OTHER

Immediate cord clamping

The umbilical cord is cut within 10 seconds after birth

Sponsors & Collaborators

  • Women and Infants Hospital of Rhode Island

    collaborator OTHER

  • Brown University

    collaborator OTHER

  • National Institute of Nursing Research (NINR)

    collaborator NIH

  • University of Rhode Island

    lead OTHER

Principal Investigators

  • Judith S Mercer, PhD, CNM · University of Rhode Island, Brown University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00818220 on ClinicalTrials.gov