Supine vs Prone Position at Birth Before Cord Clamping A Randomized Controlled Trial

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Dr Brahim Bensouda，Maisonneuve-Rosemont Hospital

Tracking Information

First Submitted Date ^ICMJE

October 4, 2018

First Posted Date ^ICMJE

October 5, 2018

Last Update Posted Date

October 5, 2018

Actual Study Start Date ^ICMJE

November 1, 2018

Estimated Primary Completion Date

November 1, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Hemoglobin[ Time Frame: 24-48 hours ]

Hemoglobin value

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Bilirubin[ Time Frame: 24-48 hours ]
Bilirubin value
CrSO2[ Time Frame: 24-48 ]
Cerebral saturation by NIRS

Descriptive Information

Brief Title ^ICMJE

Supine vs Prone Position at Birth Before Cord Clamping A Randomized Controlled Trial

Official Title ^ICMJE

Supine vs Prone Position at Birth Before Cord Clamping A Randomized Controlled Trial

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

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomised two arms study
Masking: Interventional
Masking Description:
Primary Purpose: Prevention

Condition ^ICMJE

Intervention ^ICMJE

Procedure: Delayed cord clamping
Umbilical cord clamped at 2 minutes

Study Arms

Experimental: Supine
Infant placed supine for 120 seconds before cord clamping
Experimental: Prone
Infant placed prone for 120 seconds before cord clamping

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

210

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

November 1, 2020

Estimated Primary Completion Date

November 1, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria: well appearing newborn ≥ 36 weeks gestational age and born vaginally Exclusion Criteria:out born infant, infant born by caesarian section, preterm born less than 36 weeks GA, intra uterine growth restriction (IUGR: less than 10th percentile), the 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, gestational hypertension, diabetes, hemolytic disease, on chemotherapy, insulin or cortisone are excluded. -

Sex/Gender

Sexes Eligible for Study:

All

Ages

N/A and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Dr Brahim Bensouda，Maisonneuve-Rosemont Hospital

Study Sponsor ^ICMJE

Maisonneuve-Rosemont Hospital

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

Maisonneuve-Rosemont Hospital

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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