An interventional study of positioning and positioning in Prone vs Supine Effects on Respiratory Outcomes, sponsored by Montefiore Medical Center. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2019-02-05.
Sponsored by Montefiore Medical Center · Not applicable, Interventional, and Prevention
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.
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.
Montefiore Medical Center is the lead sponsor of 402 studies on the registry; 70 are open to participants now.
Of its 81 completed or terminated interventional studies of FDA-regulated products, 73 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Prone positioned after delivery
Other: positioning
Supine positioned after delivery
Other: positioning
prone positioning for the initial 5 minutes of life
supine positioning for the initial 5 minutes of life
Administration of positive pressure ventilation and/or oxygen in prone vs supine groups
any administration of positive pressure ventilation and /or oxygen
Time frame: 30 minutes
Differences in pulse oximetry recordings between prone and supine groups
Investigators will record saturations in % at 1 min, 2 min, 3 min, 4 min, 5 min intervals and compare between the groups.
Time frame: 5 minutes
Differences in heart rate between prone and supine groups
Investigators will record heart rate (beats/minute) at 1 min, 2 min, 3 min, 4 min, 5 min time points
Time frame: 5 minutes
Differences in respiratory rate between prone and supine groups
Investigators will record respiratory rate (beats/minute) at 1 min, 2 min, 3 min, 4 min, 5 min time points
Time frame: 5 minutes
Differences in neonatal intensive care admission rates between prone and supine groups
Neonatal resuscitation team leader makes the decision regarding neonatal intensive care admission need as per Weiler Hospital/Montefiore guidelines; rates will be compared between the two groups.
Time frame: 30 minutes
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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