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Completed

NCT Number: NCT01859533

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

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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Key information

Conditions

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

Age range

Up to 2 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Other names: Early CPAP

Primary outcomes

  1. Need for admissions to NICU secondary to TTN

    Time frame: 24 hours

Secondary outcomes

  1. Levels of plasma brain natriuretic peptide and clinical outcome [Time Frame: 24 hours].

    Time frame: 24 hours

  2. Duration of tachypnea.

    Time frame: until discharge

  3. Duration and type of oxygen therapy.

    Time frame: ntil discharge

  4. Antibiotic treatment.

    Time frame: until discharge

  5. Incidence of pulmonary air leaks

    Time frame: ntil discharge

  6. Length of hospital (NICU) stay

    Time frame: until discharge

  7. Death

    Time frame: until discharge

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
May 22, 2013
Registry last updated
May 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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