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Clinical Trials/NCT01859533
NCT01859533
Completed
Phase 2

Positive End Expiratory Pressure With A T-piece Resuscitator (Neopuff) For Near-Term and Term Infants With Respiratory Distress: A Randomized, Controlled Trial

Ain Shams University0 sites64 target enrollmentStarted: November 2011Last updated:
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ConditionsTransient Tachypnea of the Newborn

Overview

Phase
Phase 2
Status
Completed
Enrollment
64
Primary Endpoint
Need for admissions to NICU secondary to TTN
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
— to 2 Days (Child)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Need for admissions to NICU secondary to TTN

Time Frame: 24 hours

Secondary Outcomes

  • Levels of plasma brain natriuretic peptide and clinical outcome [Time Frame: 24 hours].(24 hours)
  • Duration of tachypnea.(until discharge)
  • Duration and type of oxygen therapy.(ntil discharge)
  • Antibiotic treatment.(until discharge)
  • Incidence of pulmonary air leaks(ntil discharge)
  • Length of hospital (NICU) stay(until discharge)
  • Death(until discharge)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Rania Ali El-Farrash

Lecturer of Pediatrics

Ain Shams University

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