Clinical trial NCT02692573: Prone or Supine Effect After Caesarean Delivery on Respiratory Outcomes in Full Term Infants
Official title: Prone or Supine Effect of Immediate Positioning After Scheduled Caesarean Delivery on Respiratory Outcomes in Full Term Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prone vs Supine Effects on Respiratory Outcomes
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2016-02-26
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 1. Consent obtained prior to actual operative delivery and anesthesia
2. Prior to start of surgery an opaque envelope with random selection of post delivery position, supine or prone, is opened
3. Pediatric team confirms with Obstetrician and delivery team the position in which the infant will be given to pediatrics
4. Pediatric team member accepting the infant stays by the operating room table to observe the delivery At actual delivery, the Panda radiant warmer Apgar clock will be started by a Pediatric team member positioned at the warmer when the baby is delivered. Vitals signs of HR, color and oxygen saturations will be recorded each minute for first five minutes. Respiratory effort will be noted. The Apgar clock is available to document the timing of the minute intervals heart rate and oxygen saturations on the preprinted grid of the survey data sheet.

6. When a Group A (supine) infant's transfer is made to Pediatrics, the infant will be kept in the supine position in transit to warmer and on warmer until first towel drying completed, 30 - 60 seconds, consistent with NRP protocol. Pulse oximetry and temperature probe will be placed. Vitals signs of HR, color and oxygen saturations will be recorded each minute for first five minutes. Respiratory effort will be noted.

When a Group B (start in prone position) the obstetrician places the baby in prone position, clamps and cuts cord. The baby is given to Pediatrics in the prone position. The infant will be kept in the prone position in transit to warmer and on warmer for first towel drying completed. Pulse oximetry and temperature probe will be placed. Vitals signs of HR, RR and oxygen saturations will be recorded each minute for first five minutes. Respiratory effort will be documented.

7. As toweling is changed the baby in prone position continues as such until five minutes pass. After five minutes the baby is turned to supine position as per standard NRP protocol.

8. Decision to initiate positive pressure ventilation and /or oxygen supplementation will be guided by published NRP 2010 lower saturation targets (1 min \<60%, 2 min \<65%, 3 min \<70%, 4 min \<75%, 5 min \<80%) and/or by grunting, retractions ; discontinuation by high saturation targets (1min \>65%, 2 min \>70%, 3min \>\>75%, 4 min \>80%, 5 min \>85%) and resolution of respiratory distress. Positive pressure ventilation will be delivered via Neopuff device in supine position (both groups); CPAP 5cm 21% initially, then the amount of oxygen will be titrated to meet oxygen saturation target for given minute of life.

9. After no more than 30 minutes, Primary Assignment for admission to the NBN vs. NICU is made by a trained member of the study who was not in the operating room at the beginning of the delivery when the initial positioning of the infant was revealed. This is possible with 24 hour coverage from attendings, fellows, and mid-level practioners. Determination is based on Weiler NICU admission protocols.

10. If infant is to go to NBN then STS and breastfeeding protocols will be followed.

11. Infants developing respiratory distress in the NBN will be transferred to the NICU for further evaluation and care 12. Infants admitted to NICU directly or via NBN would have vital signs monitored as per NICU nursing protocol until discharge 13. Documentation of Length of Stay in NBN or NICU will collected 14. Documentation of intensity of care, type of support, maximum FiO2 required and duration of respiratory support in NICU will be collected.

Eligibility criteria: Inclusion Criteria:

* 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),

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Administration of positive pressure ventilation and/or oxygen in prone vs supine groups
timeFrame: 30 minutes
Secondary outcomes:
measure: Differences in pulse oximetry recordings between prone and supine groups
timeFrame: 5 minutes
measure: Differences in heart rate between prone and supine groups
timeFrame: 5 minutes
measure: Differences in respiratory rate between prone and supine groups
timeFrame: 5 minutes
measure: Differences in neonatal intensive care admission rates between prone and supine groups
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Weiler Hospital
state: New York
Study officials:
affiliation: Albert Einstein University/Montefiore Medical Center
name: Thomas Havranek, MD
role: PRINCIPAL_INVESTIGATOR
References: