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

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

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.

Study Overview

• Status: Completed
• Conditions: Transient Tachypnea of the Newborn
• Intervention / Treatment: Device: Neopuff

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 Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 days (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: Rania A. El-Farrash, MD, PhD, Associate Professor of Pediatrics, Department of Pediatrics, Ain Shams University, Cairo, Egypt; Study Chair: Amani O. Mahmoud, MD, Professor of Pediatrics, Department of Pediatrics, Ain Shams University, Cairo, Egypt; Principal Investigator: Enas H. Abdul-Hady, M.B.B.Ch, Ministry of Health

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: May 16, 2013
• First Submitted That Met QC Criteria: May 20, 2013
• First Posted (Estimate): May 22, 2013

Study Record Updates

• Last Update Posted (Estimate): May 22, 2013
• Last Update Submitted That Met QC Criteria: May 20, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Signs and Symptoms, Respiratory; Infant, Premature, Diseases; Respiratory Distress Syndrome, Newborn; Respiratory Distress Syndrome; Tachypnea; Transient Tachypnea of the Newborn
• Other Study ID Numbers: Ain Shams Uni