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

NCT01859533 | Completed Phase 2

• 1 other identifier: Ain Shams Uni
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Transient Tachypnea of the Newborn

Outcome Measures

Primary Outcomes (1)

• Need for admissions to NICU secondary to TTN

  24 hours

Secondary Outcomes (7)

• 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

Study Arms (2)

Neopuff group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

Neopuff 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).

Also known as: Early CPAP

Neopuff group

Eligibility Criteria

• Age: Up to 2 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

MeSH Terms

Conditions

Transient Tachypnea of the Newborn

Condition Hierarchy (Ancestors)

Respiratory Distress Syndrome, Newborn; Respiratory Distress Syndrome; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Tachypnea; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rania A. El-Farrash, MD, PhD

  Associate Professor of Pediatrics, Department of Pediatrics, Ain Shams University, Cairo, Egypt

  PRINCIPAL INVESTIGATOR

• Amani O. Mahmoud, MD

  Professor of Pediatrics, Department of Pediatrics, Ain Shams University, Cairo, Egypt

  STUDY CHAIR

• Enas H. Abdul-Hady, M.B.B.Ch

  Ministry of Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Pediatrics

Study Record Dates

• First Submitted: May 16, 2013
• First Posted: May 22, 2013
• Study Start: November 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: May 1, 2013
• Last Updated: May 22, 2013

Record last verified: 2013-05