Delayed Cord Clamping in Premature Infants

December 1, 2014 updated by: University of California, Davis

Delayed Cord Clamping: Prevention of Anemia and Hypothermia in Premature Infants

Delayed cord clamping has been shown to decrease the risk of bleeding in the brain of premature infants. However this procedure is not standard due to concerns that the premature infant will get too cold. In this study the investigators look at using a plastic covering and a chemical warmer to keep the small premature baby warm while waiting 30-60 seconds to clamp the umbilical cord.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Enrolled premature infants will be compared to age matched historical controls that did not receive delayed cord clamping but were placed under a warmer immediately after birth. Outcomes to be analyzed include initial body temperature, hematocrit at birth and 24 hours of age, number of red blood cell transfusions during hospital stay, umbilical cord gas, first blood gas following delivery, blood pressure data in the first 24 hours, fluid bolus and inotrope requirement in the first 24 hours, incidence of intraventricular hemorrhage and late-onset sepsis, peak bilirubin level, length of phototherapy, and Apgar scores.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

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
    • California
      • Sacramento, California, United States, 95817
        • UC Davis Medical Center

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

No older than 1 minute (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • premature infants at 24-28 completed weeks gestation at the time of delivery
  • informed consent obtained from parents prior to delivery

Exclusion Criteria:

  • multiple gestation (twins, triplets, etc)
  • prolonged fetal bradycardia
  • placental abruption or previa
  • maternal illness
  • major congenital anomalies
  • maternal fever in labor
  • fetal illness (e.g. isoimmune hemolysis)

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Delayed cord clamping
Other: Delayed cord clamping
Infants will be covered with plastic and placed on a chemical warmer at delivery and then clamping of the umbilical cord will be delayed for 30-60 seconds.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Initial body temperature
Time Frame: At birth
At birth

Secondary Outcome Measures

Outcome Measure
Time Frame
Hematocrit at birth and 24 hours of age
Time Frame: first day of life
first day of life

Collaborators and Investigators

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

Sponsor

University of California, Davis

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

September 1, 2009

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

November 5, 2009

First Submitted That Met QC Criteria

November 19, 2009

First Posted (Estimate)

November 23, 2009

Study Record Updates

Last Update Posted (Estimate)

December 2, 2014

Last Update Submitted That Met QC Criteria

December 1, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200916964

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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