Short-Delay Cord Clamping Compared to Extended- Delay Cord Clamping in Term Neonates That Require Resuscitation. (Term-NRIC)

June 7, 2017 updated by: Anup Katheria, M.D.

A Randomized Controlled Trial of Short-Delay Cord Clamping as Compared to Extended- Delayed Cord Clamping in Term Neonates That Require Resuscitation.

To determine whether performing extended delayed cord clamping in term neonates that require resuscitation improves early transition as compared to short-delayed cord clamping.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

All subjects will receive delayed cord clamping. One group (short-delay) will receive up to one minute of delayed cord clamping and then will be placed either on the mother's abdomen or the life-start trolley if extensive resuscitation is required.

The second group will receive delayed cord clamping for at least 5 minutes and continue until the baby has established breathing without additional support or is stable on respiratory support (no longer received mask PPV for at least 1-2 minutes, i.e. stable on CPAP or intubated). The subject will initially be placed on the mother's abdomen or if the subject needs extensive resuscitation they will be moved to the LifeStart bed to receive resuscitation measures.

In either group if the baby is deemed to be unstable (by medical team) to be on the life-start trolley the cord will be clamped and the baby will be moved to an adjacent warmer for resuscitation.

Study Type

Interventional

Enrollment (Actual)

60

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
      • San Diego, California, United States, 92123
        • Sharp Mary Birch Hospital for Women and Newborns

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

8 months to 9 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • Inclusion Criteria: Gestation 37 weeks or greater that require attendance at delivery of neonatal provider due to an at risk delivery.
  • Exclusion Criteria: Planned cesarean birth, placental abruption, multiple gestations, or known congenital anomalies.

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: Short Delay Cord Clamping
Subject will have umbilical cord clamped and cut by 1 minute of life.
Procedure: Short Delay Cord Clamping
Delay cord clamping will occur for up to 1 minute. Subject will be placed on mother's abdomen for warmth and stimulation. If the subject is depressed they will be transferred to the radiant warmer for resuscitation.
Active Comparator: Extended Delay Cord Clamping
Subject will have umbilical cord clamped and cut after at least 5 minutes of delayed cord clamping. Duration of cord clamping after 5 minutes will depend on if the subject is breathing and/or if the cord has stopped pulsating
Procedure: Extended Delay Cord Clamping
Extended delay cord clamping will occur for at least 5 minutes and will continue until the subjects begins breathing and/or the cord stops pulsating. Subject will be placed on mother's abdomen for warmth and stimulation. If the subject is depressed they will be transferred to the LifeStart bed for resuscitation adjacent to the mother's bedside.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cerebral tissue oxygenation
Time Frame: 12 hours of life
The need for oxygen, positive pressure ventilation, intubation
12 hours of life

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate
Time Frame: First 5 minutes of life
Heart rate obtained by pulse doppler, EKG, oximetry or a combination of all
First 5 minutes of life
Oxygen saturation
Time Frame: over the first 5 minutes of life
data will be averaged over each minute of life
over the first 5 minutes of life
delivery room resuscitation
Time Frame: at birth
did the infant require resuscitation such as stimulation to breathe, oxygen, positive pressure ventilation etc.
at birth
Blood pressure
Time Frame: 12 hours of life
12 hours of life
Hemoglobin
Time Frame: First 5 minutes of life
if Hemoglobin oximeter available
First 5 minutes of life
Hemoglobin
Time Frame: 12 hours of life
if Hemoglobin oximeter available
12 hours of life
Apgar Score
Time Frame: First 10 minutes of life
1, 5 and 10 minute Apgar
First 10 minutes of life
Arterial and Venous Umbilical Cord Blood Gases
Time Frame: At birth
At birth
Need for NICU admission
Time Frame: at birth
at birth
Need for hypothermia for hypoxic ischemic encepalopathy
Time Frame: at birth
will be assessed by primary physician using defined criteria for hypothermia
at birth
Hospitalization days
Time Frame: up to 24 weeks
up to 24 weeks
Bilirubin level
Time Frame: 12-48 hours
by transcutaneous or serum if available. percentile on curve will be document to adjust for different time frames.
12-48 hours
Neurodevelopmental impairment
Time Frame: 12 month followup
by Ages and Stages questionnaire or Bayley 3scales of infant and toddler development
12 month followup
Post delivery survey
Time Frame: at birth
Survey of practitioners (LD nurse, OB, neonatal team) about procedure
at birth

Collaborators and Investigators

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

Sponsor

Anup Katheria, M.D.

Investigators

  • Principal Investigator: Anup Katheria, MD, Sharp HealthCare

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

July 1, 2016

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

July 5, 2016

First Submitted That Met QC Criteria

July 6, 2016

First Posted (Estimate)

July 11, 2016

Study Record Updates

Last Update Posted (Actual)

June 8, 2017

Last Update Submitted That Met QC Criteria

June 7, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Term-NRIC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

small pilot study of term infants

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.

Clinical Trials on Placental Transfusion

Clinical Trials on Short Delay Cord Clamping

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cyprus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe