Supine vs Prone Position During Delayed Cord Clamping

Not Applicable

Completed

• Conditions: Newborn; Anemia; Umbilical Cord Problem
• Interventions: Procedure: supine or prone position

• Registration Number: NCT03697967
• Lead Sponsor: Maisonneuve-Rosemont Hospital

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.

Study Timeline

• Study First Submitted: 2018-10-04
• Study First Submitted QC: 2018-10-04
• Study First Posted: 2018-10-05
• Study Start: 2019-03-01
• Primary Completion: 2021-11-01
• Study Completion: 2021-11-01
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-06
• Last Update Posted: 2022-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prone	supine or prone position	Infant placed prone for 120 seconds before cord clamping
Supine	supine or prone position	Infant placed supine for 120 seconds before cord clamping

Primary Outcome Measures

Name	Time	Method
Hemoglobin and hematocrit	24-48 hours	Hemoglobin value

Secondary Outcome Measures

Name	Time	Method
Cerebral saturation by near infrared spectroscopy (NIRS)	24-48 H of life	Cerebral saturation by near infrared spectroscopy
Bilirubin	24-48 hours	Bilirubin value

Trial Locations

Locations (1)

Brahim Bensouda; 🇨🇦 Montréal-Est, Quebec, Canada