NCT04500353: ROSA

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

Completed NA Last updated 5 December 2023

What this trial tests

NA trial testing Face mask application for CPAP and/or PPV delivery in Infant, Premature, Diseases in 201 participants. Completed in 9 May 2023.

Timeline

11 October 2020

Primary endpoint
16 February 2023

9 May 2023

Quick facts

Lead sponsor	University College Dublin
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	201
Start date	11 October 2020
Primary completion	16 February 2023
Estimated completion	9 May 2023
Sites	1 location across Ireland

Drugs / interventions tested

• Face mask application for CPAP and/or PPV delivery

Conditions studied

• Infant, Premature, Diseases — all drugs for Infant, Premature, Diseases →
• Continuous Positive Airway Pressure — all drugs for Continuous Positive Airway Pressure →
• Positive-Pressure Respiration — all drugs for Positive-Pressure Respiration →
• Resuscitation — all drugs for Resuscitation →

Sponsor

University College Dublin

Who can join

Adults 0 Minutes to 5 Minutes, any sex, with Infant, Premature, Diseases or Continuous Positive Airway Pressure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.