Ventilatory Management of the Preterm Neonate in the Delivery Room

PHASE2CompletedINTERVENTIONAL
Enrollment

112

Participants

Timeline

Start Date

January 31, 2012

Primary Completion Date

December 31, 2013

Study Completion Date

December 31, 2013

Conditions
Respiratory Distress Syndrome, Newborn
Interventions
PROCEDURE

Resuscitation of preterm neonates by sustained lung inflation through T piece device followed by CPAP

After oropharyngeal and nasal suctioning, if there are no signs of spontaneous breathing or breathing is insufficient and/or heart rate is below 100 bpm, the following approach will be followed:Pressure-controlled (20 cm H2O) inflation will be sustained for 15 secs, using a neonatal mask and a T-piece ventilator (NeoPuff Infant Resuscitator; Fisher \& Paykel).To avoid pressure leakage, we will use a neonatal mask of appropriate size which adequately cover both the mouth and nostrils of infants. This pressure controlled inflation will be followed by CPAP at 5 Cm H2O.This procedure will be repeated a second time with a pressure of 25 cm H2O for 15 secs if breathing remained insufficient and/or the heart rate is \< 100 bpm and/or the infant is cyanotic. To be followed by CPAP at 6 Cm H2O.A third puff with a pressure of 30 cm H2O for 15 secs will be used after few seconds if inadequate heart rate and respiration was not reached. This will be followed by CPAP at 7 Cm H2O.

PROCEDURE

Resuscitation of preterm neonates by intermittent bag and mask ventilation using self inflating bag.

After oropharyngeal and nasal suctioning, if there is no signs of spontaneous breathing or breathing is insufficient and/or heart rate is below 100 bpm, intermittent mask and bag ventilation will be administrated at a rate 40-60 per minute using a self-inflating bag and mask with an oxygen reservoir.

Trial Locations (1)

Unknown

Gynecology and Obstetrics hospital, Ain-Shams University, Cairo

All Listed Sponsors
lead

Ain Shams University

OTHER

NCT01255826 - Ventilatory Management of the Preterm Neonate in the Delivery Room | Biotech Hunter | Biotech Hunter