Clinical trial NCT01859533: Positive End Expiratory Pressure With A T-piece Resuscitator For Near-Term and Term Infants With Respiratory Distress
Official title: Positive End Expiratory Pressure With A T-piece Resuscitator (Neopuff) For Near-Term and Term Infants With Respiratory Distress: A Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Transient Tachypnea of the Newborn
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2013-05-22
Enrollment: 64
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 complication of TTN.

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 TTN and the need for neonatal intensive care unit (NICU) admission of near term and term infants with respiratory distress.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Need for admissions to NICU secondary to TTN
timeFrame: 24 hours
Secondary outcomes:
measure: Levels of plasma brain natriuretic peptide and clinical outcome [Time Frame: 24 hours].
timeFrame: 24 hours
measure: Duration of tachypnea.
timeFrame: until discharge
measure: Duration and type of oxygen therapy.
timeFrame: ntil discharge
measure: Antibiotic treatment.
timeFrame: until discharge
measure: Incidence of pulmonary air leaks
timeFrame: ntil discharge
measure: Length of hospital (NICU) stay
timeFrame: until discharge
measure: Death
timeFrame: until discharge
Other outcomes:
Locations:
Study officials:
affiliation: Associate Professor of Pediatrics, Department of Pediatrics, Ain Shams University, Cairo, Egypt
name: Rania A. El-Farrash, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor of Pediatrics, Department of Pediatrics, Ain Shams University, Cairo, Egypt
name: Amani O. Mahmoud, MD
role: STUDY_CHAIR
affiliation: Ministry of Health
name: Enas H. Abdul-Hady, M.B.B.Ch
role: PRINCIPAL_INVESTIGATOR
References: