Loading clinical trials...
Loading clinical trials...
Prone or Supine Effect of Immediate Positioning After Scheduled Caesarean Delivery on Respiratory Outcomes in Full Term Infants
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.
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.
Age
All ages
Sex
ALL
Healthy Volunteers
No
Weiler Hospital
The Bronx, New York, United States
Start Date
December 1, 2015
Primary Completion Date
December 2, 2018
Completion Date
December 18, 2018
Last Updated
February 5, 2019
500
ACTUAL participants
positioning
OTHER
positioning
OTHER
Lead Sponsor
Montefiore Medical Center
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions