Status:
COMPLETED
Positive End Expiratory Pressure With A T-piece Resuscitator For Near-Term and Term Infants With Respiratory Distress
Lead Sponsor:
Ain Shams University
Conditions:
Transient Tachypnea of the Newborn
Eligibility:
All Genders
Up to 2 years
Phase:
PHASE2
Brief Summary
Evaluating the effect of early application of Continuous positive airway pressure (CPAP) via Neopuff in cases of transient tachypnea of the newborn(TTN) and its role in decreasing the duration and com...
Detailed Description
The aim of the study is to determine whether positive end expiratory pressure therapy (PEEP) administered early via a T piece based infant resuscitator (Neopuff) would safely reduce the incidence of T...
Eligibility Criteria
Inclusion
- Near term infants (36-37 weeks gestational age) and Full term infants (38-41 weeks gestational age).
- Presence of signs of respiratory distress (Tachypnea, intercostal and subcostal retractions, nasal flaring and grunting) evident shortly after birth.
- Cesarean section (CS) was defined as elective when surgery was performed before the onset of labor, with all other cases defined as secondary CS.
Exclusion
- Presence of any of the risk factors for neonatal sepsis such as Prolonged Rupture of Membranes for ≥48 hours (PROM), maternal fever, maternal chorioamnionitis or positive maternal GBS colonization.
- Presence of any other cause of respiratory distress, eg.
- congenital malformations affecting the cardiorespiratory system ,
- chromosomal aberrations,
- depression at birth (Apgar score at 5 minutes of \< 7 or umbilical artery pH of \< 7.10),
- fetal hydrops,
- persistent pulmonary hypertension,
- and meconium aspiration syndrome.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT01859533
Start Date
November 1 2011
End Date
May 1 2013
Last Update
May 22 2013
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