Supine vs Prone Position During Delayed Cord Clamping

Study Overview
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Brief Summary
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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
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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.

Official Title
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Supine vs Prone Position During Delayed Cord Clamping in Term Infants A Randomized Trial

Conditions
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Umbilical Cord Problem, Newborn; Anemia

Intervention / Treatment
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* Procedure: supine or prone position


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Minute
Maximum Age: 2 Minutes

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supine<br>Infant placed supine for 120 seconds before cord clamping | Procedure: supine or prone position<br>* 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.<br>* Other names: delay cord clamping;|
| Experimental: Prone<br>Infant placed prone for 120 seconds before cord clamping | Procedure: supine or prone position<br>* 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.<br>* Other names: delay cord clamping;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin and hematocrit | Hemoglobin value | 24-48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebral saturation by near infrared spectroscopy (NIRS) | Cerebral saturation by near infrared spectroscopy | 24-48 H of life | 
| Bilirubin | Bilirubin value | 24-48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Delayed cord clamping