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Routine Or Selective Application of a Face Mask for Preterm Infants at Birth: the ROSA Trial

NCT04500353 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 201

Last updated 2023-12-05

No results posted yet for this study

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.

Conditions

  • Infant, Premature, Diseases
  • Continuous Positive Airway Pressure
  • Positive-Pressure Respiration
  • Resuscitation
  • Respiratory Distress Syndrome, Newborn

Interventions

OTHER

Face mask application for CPAP and/or PPV delivery

Face mask application for CPAP and/or PPV delivery

Sponsors & Collaborators

  • University College Dublin

    lead OTHER

Principal Investigators

  • Colm PF O'Donnell, PhD · National Maternity Hospital; University College Dublin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
0 Minutes
Max Age
5 Minutes
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-11
Primary Completion
2023-02-16
Completion
2023-05-09

Countries

  • Ireland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04500353 on ClinicalTrials.gov