Positive End Expiratory Pressure With A T-piece Resuscitator For Near-Term and Term Infants With Respiratory Distress

Phase 2

Completed

• Conditions: Transient Tachypnea of the Newborn
• Interventions: Device: Neopuff

• Registration Number: NCT01859533
• Lead Sponsor: Ain Shams University

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 Timeline

• Study Start: 2011-11
• Primary Completion: 2013-01
• Status Verified: 2013-05
• Study Completion: 2013-05
• Study First Submitted: 2013-05-16
• Study First Submitted QC: 2013-05-20
• Last Update Submitted: 2013-05-20
• Study First Posted: 2013-05-22
• Last Update Posted: 2013-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neopuff group	Neopuff	includes 34 newborns showing signs of TTN who received CPAP (5 cm of H2O) via T- piece (Neopuff; Fisher and Paykel Healthcare, Auckland, New Zealand).

Primary Outcome Measures

Name	Time	Method
Need for admissions to NICU secondary to TTN	24 hours

Secondary Outcome Measures

Name	Time	Method
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