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Supine vs Prone Position During Delayed Cord Clamping (DCC)

Primary Purpose

Newborn; Anemia, Umbilical Cord Problem

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

supine or prone position

About this trial

This is an interventional prevention trial for Newborn; Anemia focused on measuring Delayed cord clamping

Eligibility Criteria

1 Minute - 2 Minutes (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Brahim Bensouda

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Supine

Prone

Arm Description

Infant placed supine for 120 seconds before cord clamping

Infant placed prone for 120 seconds before cord clamping

Outcomes

Primary Outcome Measures

Hemoglobin and hematocrit

Hemoglobin value

Secondary Outcome Measures

Cerebral saturation by near infrared spectroscopy (NIRS)

Cerebral saturation by near infrared spectroscopy

Bilirubin

Bilirubin value

Full Information

NCT ID

NCT03697967

First Posted

October 4, 2018

Last Updated

April 6, 2022

Sponsor

Maisonneuve-Rosemont Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03697967

Brief Title

Supine vs Prone Position During Delayed Cord Clamping

Acronym

DCC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Completed

Study Start Date

March 1, 2019 (Actual)

Primary Completion Date

November 1, 2021 (Actual)

Study Completion Date

November 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Maisonneuve-Rosemont Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Newborn; Anemia, Umbilical Cord Problem

Keywords

Delayed cord clamping

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Randomised two arms study

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

210 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Supine

Arm Type

Experimental

Arm Description

Infant placed supine for 120 seconds before cord clamping

Arm Title

Prone

Arm Type

Experimental

Arm Description

Infant placed prone for 120 seconds before cord clamping

Intervention Type

Procedure

Intervention Name(s)

supine or prone position

Other Intervention Name(s)

delay cord clamping

Intervention Description

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.

Primary Outcome Measure Information:

Title

Hemoglobin and hematocrit

Description

Hemoglobin value

Time Frame

24-48 hours

Secondary Outcome Measure Information:

Title

Cerebral saturation by near infrared spectroscopy (NIRS)

Description

Cerebral saturation by near infrared spectroscopy

Time Frame

24-48 H of life

Title

Bilirubin

Description

Bilirubin value

Time Frame

24-48 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Minute

Maximum Age & Unit of Time

2 Minutes

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Brahim Bensouda

City

Montréal-Est

State/Province

Quebec

ZIP/Postal Code

H1T2M4

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

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Supine vs Prone Position During Delayed Cord Clamping

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