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

Study Overview
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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.

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.

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

Conditions
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Transient Tachypnea of the Newborn

Intervention / Treatment
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* Device: Neopuff


Participation Criteria
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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.

Ages Eligible for Study
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Maximum Age: 2 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neopuff group<br>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). | Device: Neopuff<br>* 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).<br>* Other names: Early CPAP;|
| No Intervention: Control group<br>includes 30 newborns who will receive nasal prong oxygen treatment; standard care according to Siva Subramanian et al. (2010). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for admissions to NICU secondary to TTN |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |