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CompletedNCT01859533Updated May 22, 2013

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

A Phase 2 interventional study of Neopuff in Transient Tachypnea of the Newborn, sponsored by Ain Shams University. Completed. Open to participants aged Up to 2 Days. Per ClinicalTrials.gov, last updated 2013-05-22.

Sponsored by Ain Shams University · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
Up to 2 Days
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Transient Tachypnea of the Newborn
03

In context

Transient Tachypnea of the Newborn

38 studies on the registry are indexed under Transient Tachypnea of the Newborn; 3 are open to participants now.

This study's enrollment of 64 is close to the median of 65 across 27 interventional studies indexed under Transient Tachypnea of the Newborn.

Browse Transient Tachypnea of the Newborn studies →

Lead sponsor

Ain Shams University is the lead sponsor of 1,932 studies on the registry; 433 are open to participants now.

Of its 33 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Browse Ain Shams University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 2 Days
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
64 participants (actual)

Study arms

  • 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

  • No intervention
    Control group

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

Interventions

  • DeviceNeopuff

    * 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

06

What researchers measure

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

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2011, a primary completion of Jan 2013 and a completion of May 2013. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 16, 2013
First posted
May 22, 2013
Start
Nov 2011
Primary completionActual
Jan 2013
CompletionActual
May 2013
Last update
May 22, 2013
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 22, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01859533
Lead sponsor
Ain Shams University
Responsible party
Rania Ali El-Farrash (Lecturer of Pediatrics, Ain Shams University) — Principal investigator
First posted
May 22, 2013
Start date
Nov 2011
Primary completion
Jan 2013
Completion
May 2013
Last update
May 22, 2013

Study contacts

Rania A. El-Farrash, MD, PhD
principal investigator · Associate Professor of Pediatrics, Department of Pediatrics, Ain Shams University, Cairo, Egypt
Amani O. Mahmoud, MD
study chair · Professor of Pediatrics, Department of Pediatrics, Ain Shams University, Cairo, Egypt
Enas H. Abdul-Hady, M.B.B.Ch
principal investigator · Ministry of Health

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2013. You cannot join it, but the record below documents what was studied.

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