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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2013-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Transient Tachypnea of the Newborn

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Neopuff group

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).

Group Type EXPERIMENTAL

Neopuff

Intervention Type DEVICE

* Group I neonates (Experimental group) includes 30 newborns showing signs of TTN who will receive administration of CPAP (5 cm of H2O) via T- piece (Neopuff; Fisher and Paykel Healthcare, Auckland, New Zealand).
* Group II neonates (Control group) includes 30 newborns who will receive nasal prong oxygen treatment; standard care according to Siva Subramanian et al. (2010).

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Neopuff

* Group I neonates (Experimental group) includes 30 newborns showing signs of TTN who will receive administration of CPAP (5 cm of H2O) via T- piece (Neopuff; Fisher and Paykel Healthcare, Auckland, New Zealand).
* Group II neonates (Control group) includes 30 newborns who will receive nasal prong oxygen treatment; standard care according to Siva Subramanian et al. (2010).

Intervention Type DEVICE

Other Intervention Names

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Early CPAP

Eligibility Criteria

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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.

Maximum Eligible Age

2 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No