Weiler Hospital
The Bronx, New York, 10461, United States
NCT Number: NCT02692573
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.
Looking for future studies?
Notify MeAll sexes
Interventional
Not applicable
The Bronx, New York, 10461, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
prone positioning for the initial 5 minutes of life
Time frame: 30 minutes
any administration of positive pressure ventilation and /or oxygen
Time frame: 5 minutes
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
Investigators will record heart rate (beats/minute) at 1 min, 2 min, 3 min, 4 min, 5 min time points
Time frame: 5 minutes
Investigators will record respiratory rate (beats/minute) at 1 min, 2 min, 3 min, 4 min, 5 min time points
Time frame: 30 minutes
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.
Montefiore Medical Center
Other
Prone or Supine Effect of Immediate Positioning After Scheduled Caesarean Delivery on Respiratory Outcomes in Full Term Infants
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.