Supine vs Prone Position During Delayed Cord Clamping (DCC)

April 6, 2022 updated by: Dr Brahim Bensouda, Maisonneuve-Rosemont Hospital

Supine vs Prone Position During Delayed Cord Clamping in Term Infants A Randomized Trial

This study is conducted to evaluate if the prone position of the newborn on the chest of his mother at birth before delayed cord clamping leads to better hematocrit and hemoglobin at 24-48 hours of life compared to supine position.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

At 30 hours of life, laboratory personnel drew a capillary sample from the infant's heel for hemoglobin, hematocrit, and total serum bilirubin at the same time as the newborn metabolic screening sample. There is no added heelstick to routine care, as current standard in our institution requires the bilirubin to be drawn at 30 hours of life.

During universal screening for congenital cardiac defects (30 hours of life), a value of cerebral saturation (CrSO2) is measured using NIRS with INVOS (In Vivo Optical Spectroscopy, INVOS System, Covidien, Dublin, Ireland, Somanetics). Sensors are placed over the forehead and the newborn is in supine position.

Study Type

Interventional

Enrollment (Actual)

210

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

    • Quebec
      • Montréal-Est, Quebec, Canada, H1T2M4
        • Brahim Bensouda

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

1 minute to 2 minutes (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Newborn ≥ 36 weeks gestational age and Born vaginally and Well appearing

Exclusion Criteria:

Out born infant, Infant born by caesarian section, Preterm born less than 36 weeks GA, Infant with intra uterine growth restriction (IUGR: less than 10th percentile) Asphyxiated infant Infant needing immediate resuscitation, Newborn with malformation (gastroschisis, omphalocele, anal atresia, severe head skin injury, congenital cardiac disease Newborn with mother with preeclampsia or gestational hypertension or diabetes on insuline or hemolytic disease or on chemotherapy or on cortisone.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Supine
Infant placed supine for 120 seconds before cord clamping

Before delivery, a sealed enveloppe is opened by the physician or nurse present at delivery. Immediately at birth the team in charge of delivery place the newborn in skin to skin contact on the mother's chest where he is dried. Umbilical cord clamping is delayed in both intervention arms to 1 minute after birth.

The newborn is placed in the prone or in the supine position depending on allocation. The nurse in charge of the newborn uses a stopwatch to check the time at which clamping was accomplished.

All subsequent nursery care are conducted according to hospital protocol.

Other Names:
  • delay cord clamping
Experimental: Prone
Infant placed prone for 120 seconds before cord clamping

Before delivery, a sealed enveloppe is opened by the physician or nurse present at delivery. Immediately at birth the team in charge of delivery place the newborn in skin to skin contact on the mother's chest where he is dried. Umbilical cord clamping is delayed in both intervention arms to 1 minute after birth.

The newborn is placed in the prone or in the supine position depending on allocation. The nurse in charge of the newborn uses a stopwatch to check the time at which clamping was accomplished.

All subsequent nursery care are conducted according to hospital protocol.

Other Names:
  • delay cord clamping

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin and hematocrit
Time Frame: 24-48 hours
Hemoglobin value
24-48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cerebral saturation by near infrared spectroscopy (NIRS)
Time Frame: 24-48 H of life
Cerebral saturation by near infrared spectroscopy
24-48 H of life
Bilirubin
Time Frame: 24-48 hours
Bilirubin value
24-48 hours

Collaborators and Investigators

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

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)

March 1, 2019

Primary Completion (Actual)

November 1, 2021

Study Completion (Actual)

November 1, 2021

Study Registration Dates

First Submitted

October 4, 2018

First Submitted That Met QC Criteria

October 4, 2018

First Posted (Actual)

October 5, 2018

Study Record Updates

Last Update Posted (Actual)

April 14, 2022

Last Update Submitted That Met QC Criteria

April 6, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 2019-1594

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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