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Supine vs Prone Position During Delayed Cord Clamping (DCC)

M

Maisonneuve-Rosemont Hospital

Status

Completed

Conditions

Newborn; Anemia
Umbilical Cord Problem

Treatments

Procedure: supine or prone position

Study type

Interventional

Funder types

Other

Identifiers

NCT03697967
2019-1594

Details and patient eligibility

About

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.

Full 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.

Enrollment

210 patients

Sex

All

Ages

1 to 2 minutes old

Volunteers

Accepts 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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

210 participants in 2 patient groups

Supine
Experimental group
Description:
Infant placed supine for 120 seconds before cord clamping
Treatment:
Procedure: supine or prone position
Prone
Experimental group
Description:
Infant placed prone for 120 seconds before cord clamping
Treatment:
Procedure: supine or prone position

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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