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

May 26, 2015 updated by: Judith S Mercer, University of Rhode Island

Protective Effects of Delayed Cord Clamping in VLBW Infants

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The current obstetrical practice at birth in the United States is that the umbilical cord of the very low birth weight (VLBW) infant is clamped immediately. When immediate cord clamping occurs, up to 25% of the fetal-placental blood volume may be left in the placenta acutely increasing vulnerability to hypovolemia. Hypovolemia can precipitate a cascade of physiologic events including poor tissue perfusion, ischemia, and initiation of the fetal/neonatal inflammatory response. Intraventricular hemorrhage (IVH) is a major cause of brain injury for preterm infants and is a predictor of poor neurodevelopment outcomes. Late onset sepsis (LOS) is also associated with morbidity and mortality in the NICU and later developmental delay. Of the approximately 57,000 infants born annually at less than 1500 grams, 10% develop cerebral palsy and 25 to 50% show later cognitive and behavioral deficits affecting school performance with higher rates found in males. We propose a trial with a sample of 212 randomized infants to validate our prior findings that delaying the cord clamping lowers the incidence of intraventricular hemorrhage and late onset sepsis, and to identify the mechanisms of effect through the study of biologic markers including measurement of cytokines, circulating stem cells, and red cell volume. Enrolled women in preterm labor will be randomized at birth to the immediate cord clamping group or the delayed clamping group. Assessment of motor outcomes is planned at 7 months corrected age. This study will help to establish a scientific basis for the timing of cord clamping of VLBW infants. The innovation of this study is in the simplicity of delaying cord clamping for 30 to 45 seconds and lowering the VLBW infants at birth. This low-tech change in a clinical practice has the potential to reduce the risk of disease and disability and to improve the neonatal and early childhood outcomes for these most vulnerable preterm infants.

Study Type

Interventional

Enrollment (Actual)

211

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Women and Infants Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Pregnant women between 24 and 31.6 weeks gestation at risk of delivery
  • Vaginal or cesarean birth

Exclusion Criteria:

  • Congenital anomaly
  • Multiple gestation
  • Intent to withhold or withdraw care
  • Severe or multiple maternal illnesses
  • Mothers who are institutionalized or psychotic

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1-Delayed Cord Clamping (DCC)
Immediately after birth, the infant is placed in a warm blanket and held lower than the placenta. The research nurse counts out 30 to 45 seconds for the obstetrician. The cord is milked once and then clamped at 30 to 45 seconds after birth.
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 Names:
  • immediate cord clamping
  • cord milking
Active Comparator: 2-Immediate Cord Clamping (ICC)
Routine care which is immediate cord clamping
Other: Immediate cord clamping
The umbilical cord is cut within 10 seconds after birth
Other Names:
  • routine care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Very low birth weight (VLBW) infants in the delayed cord clamping (DCC) group will have less intraventricular hemorrhage (IVH) compared to VLBW infants in the immediate clamped (ICC) group
Time Frame: December, 2012
December, 2012
Very low birth weight infants in the delayed cord clamping group will have less late onset sepsis than those in the immediate clamping group
Time Frame: December 2012
December 2012

Secondary Outcome Measures

Outcome Measure
Time Frame
VLBW infants in the DCC group will have better motor function at 7 months corrected age
Time Frame: November 2012
November 2012

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rhode Island

Collaborators

National Institute of Nursing Research (NINR)
Brown University
Women and Infants Hospital of Rhode Island

Investigators

  • Principal Investigator: Judith S Mercer, PhD, CNM, University of Rhode Island, Brown University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

January 5, 2009

First Submitted That Met QC Criteria

January 6, 2009

First Posted (Estimate)

January 7, 2009

Study Record Updates

Last Update Posted (Estimate)

May 27, 2015

Last Update Submitted That Met QC Criteria

May 26, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2980022
  • 5R01NR010015-02 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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