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

Transient Tachypnea of the Newborn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01859533
• Other study ID #: Ain Shams Uni
• Status: Completed
• Phase: Phase 2
• First received: May 16, 2013
• Last updated: May 20, 2013
• Start date: November 2011
• Est. completion date: May 2013

Study information

• Verified date: May 2013
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: May 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 2 Days

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Transient Tachypnea of the Newborn

Intervention

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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Need for admissions to NICU secondary to TTN		24 hours	No
Secondary	Levels of plasma brain natriuretic peptide and clinical outcome [Time Frame: 24 hours].		24 hours	No
Secondary	Duration of tachypnea.		until discharge	No
Secondary	Duration and type of oxygen therapy.		ntil discharge	No
Secondary	Antibiotic treatment.		until discharge	No
Secondary	Incidence of pulmonary air leaks		ntil discharge	Yes
Secondary	Length of hospital (NICU) stay		until discharge	No
Secondary	Death		until discharge	No