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

Ain Shams University

Status and phase: Completed; Phase 2

Conditions: Transient Tachypnea of the Newborn

Treatments: Device: Neopuff

Study type: Interventional

Funder types: Other

Identifiers

NCT01859533

Ain Shams Uni

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: All

Ages: Under 2 days old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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64 participants in 2 patient groups

Neopuff group

Experimental group

Description:

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).

Treatment:

Device: Neopuff

Control group

No Intervention group

Description:

includes 30 newborns who will receive nasal prong oxygen treatment; standard care according to Siva Subramanian et al. (2010).