Delayed Cord Clamping in Very Low Birth Weight Infants (DCC)

August 28, 2017 updated by: University of Chicago

Delayed Cord Clamping at 30 vs. 60 Seconds for Very Low Birth Weight Infants: A Randomized Controlled Trial

The purpose of this study is to determine if there is a difference in neonatal outcomes with delayed umbilical cord clamping at 30 versus 60 seconds. Our primary outcome will be intraventricular hemorrhage (IVH) (bleeding in the brain) in these infants.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Immediately following delivery, up to 40% of the total blood volume available to the infant is in the placenta. Over a period of 30 seconds to 3 minutes, a significant portion of this blood is transferred to the infant through the umbilical cord. Delayed cord clamping following delivery facilitates this transfer of blood.

Preterm infants are very susceptible to the effects of anemia and hypovolemia. A recent meta-analysis showed that a brief delay in umbilical cord clamping (30-60 seconds) decreases the risk of anemia, blood transfusion, intraventricular hemorrhage, necrotizing enterocolitis, and the need for blood pressure support after delivery. The same meta-analysis showed no impact on Apgar scores or hypothermia due to a brief delay in resuscitation efforts to allow delayed cord clamping.

Preterm infants are at significant risk for IVH and as high as 20% of very low birth weight infants will have it. IVH is an important cause of brain injury in these infants. In our study, we would like to determine the optimal timing of delayed cord clamping in order to prevent IVH in these infants.

Study Type

Interventional

Enrollment (Actual)

39

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
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago 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

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Pregnant women who are expected to deliver a very low birth weight infant
  • Neonates born weighing >= 500g and <1500 grams
  • Mother 18 years of age or older
  • English speaking mother

Exclusion Criteria:

  • Placental abruption
  • Vasa previa
  • Fetal hydrops or other signs of fetal volume overload
  • Other major fetal anomalies
  • Placenta Accreta
  • Mother < 18 years of age
  • Non-English speaking mother
  • Infants >= 1500g (3.3 lbs) or <500g

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 30 seconds
For subjects in the 30 second arm, the umbilical cord will be clamped at 30 seconds after delivery.
Procedure: Delayed cord clamping at 30 seconds
For subjects enrolled in the 30 second arm, the umbilical cord will be clamped at exactly 30 seconds after delivery
Experimental: 60 seconds
For subjects in the 60 second arm, the umbilical cord will be clamped at 60 seconds after delivery.
Procedure: Delayed cord clamping at 60 seconds
For subjects enrolled in the 60 second arm, the umbilical cord will be clamped at exactly 60 seconds after delivery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraventricular hemorrhage
Time Frame: During NICU admission up to 6 months
Neonates will be followed for up to 6-months during NICU admission to assess for the development of intraventricular hemorrhage.
During NICU admission up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin and hematocrit
Time Frame: During NICU admission up to 6 months
Neonates will be followed for up to 6-months and initial H/H will be recorded.
During NICU admission up to 6 months
Need for blood transfusion
Time Frame: During NICU admission up to 6 months
Neonates will be followed for up to 6-months and assessed for clinical or laboratory evidence of need for transfusion.
During NICU admission up to 6 months
Bilirubin levels
Time Frame: During NICU admission up to 6 months
Neonates will be followed for up to 6-months and assessed for clinical jaundice.
During NICU admission up to 6 months
Delivery room temperature
Time Frame: Delivery
Neonates will be assessed for hypothermia at the time of delivery.
Delivery

Collaborators and Investigators

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

Sponsor

University of Chicago

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 (Actual)

April 16, 2015

Primary Completion (Actual)

May 17, 2017

Study Completion (Actual)

August 28, 2017

Study Registration Dates

First Submitted

December 15, 2014

First Submitted That Met QC Criteria

January 12, 2015

First Posted (Estimate)

January 13, 2015

Study Record Updates

Last Update Posted (Actual)

August 29, 2017

Last Update Submitted That Met QC Criteria

August 28, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-0546

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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