Supine vs Prone Position During Delayed Cord Clamping in Term Infants A Randomized Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 210
- Locations
- 1
- Primary Endpoint
- Hemoglobin and hematocrit
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 1 Minute to 2 Minutes (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Supine
Infant placed supine for 120 seconds before cord clamping
Intervention: supine or prone position (Procedure)
Prone
Infant placed prone for 120 seconds before cord clamping
Intervention: supine or prone position (Procedure)
Outcomes
Primary Outcomes
Hemoglobin and hematocrit
Time Frame: 24-48 hours
Hemoglobin value
Secondary Outcomes
- Cerebral saturation by near infrared spectroscopy (NIRS)(24-48 H of life)
- Bilirubin(24-48 hours)
Investigators
Dr Brahim Bensouda
MD
Maisonneuve-Rosemont Hospital