Prone or Supine Effect After Caesarean Delivery on Respiratory Outcomes in Full Term Infants

Completed · Not applicable

Conditions studied: Prone vs Supine Effects on Respiratory Outcomes

In brief

Investigators will compare 500 full term babies delivered by SCD randomized into two groups, prone or supine position. Investigators will use a Panda warmer with built in Nellcor pulse oximeter. Each infant will have heart rate (HR), oxygen saturation via pulse oximetry, respiratory rate and respiratory effort documented every 1 minute for the first 5 minutes of life; beyond the initial 5minutes of life, monitoring as well as infant's management will be done as per current Weiler hospital protocols. The intervention group will be placed in prone position for first five minutes immediately after birth, and then changed to supine position. The control group will be placed supine from birth. Investigators will check for the incidence and severity of RD, supplemental oxygen need and duration, positive pressure ventilation (PPV) need and duration or other use of respiratory support (intubation). Additionally, investigators will record the number of infants requiring admission to the NICU in each group, days of ventilatory support as well as the length of hospitalization.

Key facts

Study ID

NCT02692573

Run by

Montefiore Medical Center

People needed

500

Starts

2015-12-01

Expected to finish

2018-12-18

Last updated by the study team

2019-02-05

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Obstetrical patients delivering at Weiler Hospital.
• Any woman not in labor, who is undergoing scheduled caesarean deliveries at term (37 - 42 completed weeks of gestation),

You may not qualify if…

• Women with prior rupture of membranes
• Women receiving magnesium sulfate
• Women with known illegal drug history
• fetus with known congenital anomalies or if meconium stained fluid is present.
• mother with maternal fever, chorioamnionitis
• babies experiencing fetal distress e.g. abnormal fetal heart tracing,
• non vigorous newborn at birth (defined as per NRP guidelines as infant with apnea/gasping, heart rate <100/min, poor tone).

Where it is running

• Weiler Hospital — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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