Supine vs Prone Position During Delayed Cord Clamping

Maisonneuve-Rosemont Hospital210 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

210

Conditions

Newborn; Anemia Umbilical Cord Problem

Interventions

supine or prone positionPROCEDURE

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.

Eligibility

Sex: ALLMin age: 1 MinuteMax age: 2 MinutesHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Brahim Bensouda

Montreal East, Quebec, Canada

Outcomes

Primary Outcomes

Hemoglobin and hematocrit

Hemoglobin value

Time frame: 24-48 hours

Secondary Outcomes

Cerebral saturation by near infrared spectroscopy (NIRS)

Cerebral saturation by near infrared spectroscopy

Time frame: 24-48 H of life

Bilirubin

Bilirubin value

Time frame: 24-48 hours

Data from ClinicalTrials.gov

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