CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 201 enrolled
Drug / intervention
Face mask application for CPAP and/or PPV deliveryother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04500353
NCT04500353N/ACompleted

A Randomised Trial of Routine or Selective Application of a Face Mask for Preterm Infants at Birth

University College Dublin·interventional·Posted Aug 5, 2020·Updated Dec 5, 2023

In Brief

A clinical study evaluating Face mask application for CPAP and/or PPV delivery for Infant, Premature, Diseases and 4 related conditions. Completed, enrolled 201 participants across 1 site.

Detailed Summary

International guidelines recommend giving positive pressure ventilation (PPV) by face mask to newborns who do not breathe or have a slow heart rate at birth. Preterm infants are at high risk of developing respiratory distress syndrome (RDS) and many are treated with continuous positive airway pressure (CPAP) in the neonatal intensive care unit (NICU). Though the majority of preterm infants breathe spontaneously at birth, many clinicians routinely apply a face mask to preterm infants shortly after birth in the delivery room (DR) to give them CPAP. However, applying a face mask may inhibit spontaneous breathing in newborns. In this study, premature babies will be randomly assigned to have a face mask routinely applied for CPAP shortly after birth; or to have a face mask selectively applied only for PPV if they are not breathing or have a slow heart beat in the first 5 minutes of life, or for CPAP if they have signs of respiratory distress after 5 minutes. The investigators will determine whether fewer participants who have the mask selectively applied receive PPV in the DR.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesIreland
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedAug 5, 2020
Enrollment StartOct 11, 2020
Primary CompletionFeb 16, 2023
Study CompletionMay 9, 2023
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 5.9 years ago

Interventions

Face mask application for CPAP and/or PPV deliveryother

Face mask application for CPAP and/or PPV delivery