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

NCT04500353 | Completed DMC

• 1 other identifier: ROSA.01
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• The proportion of participants who receive face mask PPV in the delivery room DR

  The proportion of participants who receive face mask positive pressure ventilation (PPV) in the delivery room (DR)

  Within 30 minutes of birth

Secondary Outcomes (23)

• The proportion of participants who receive face mask CPAP in the first 5 minutes of life

  5 minutes

• The proportion of participants who receive face mask PPV in the first 5 minutes of life

  5 minutes

• HR at 5 minutes of life

  5 minutes

• SpO2 at 5 minutes of life

  5 minutes

• The proportion of participants who receive face mask CPAP in the DR

  Within 30 minutes of birth

Study Arms (2)

Routine face mask application

ACTIVE COMPARATOR

Routine application of a face mask shortly after birth to deliver continuous positive airway pressure (CPAP)

Other: Face mask application for CPAP and/or PPV delivery

Selective face mask application

EXPERIMENTAL

Selective application of a face mask to give positive pressure ventilation (PPV) for apnoea or bradycardia \[heart rate (HR) \< 100 beats per minute (bpm)\] at any time in the delivery room (DR); or to give CPAP for signs of respiratory distress after 5 minutes of life

Other: Face mask application for CPAP and/or PPV delivery

Interventions

Face mask application for CPAP and/or PPV delivery OTHER

Face mask application for CPAP and/or PPV delivery

Routine face mask application; Selective face mask application

Eligibility Criteria

• Age: 0 Minutes - 5 Minutes
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Born before 32 weeks gestational age by best obstetric estimate

You may not qualify if:

• Infants with major congenital anomalies

Sponsors & Collaborators

• University College Dublin: lead

Study Sites (1)

National Maternity Hospital

Dublin, D02 YH21, Ireland

Location

Related Publications (14)

• Perlman JM, Wyllie J, Kattwinkel J, Wyckoff MH, Aziz K, Guinsburg R, Kim HS, Liley HG, Mildenhall L, Simon WM, Szyld E, Tamura M, Velaphi S; Neonatal Resuscitation Chapter Collaborators. Part 7: Neonatal Resuscitation: 2015 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations. Circulation. 2015 Oct 20;132(16 Suppl 1):S204-41. doi: 10.1161/CIR.0000000000000276. No abstract available.

  PMID: 26472855 BACKGROUND

• O'Donnell CP, Kamlin CO, Davis PG, Morley CJ. Crying and breathing by extremely preterm infants immediately after birth. J Pediatr. 2010 May;156(5):846-7. doi: 10.1016/j.jpeds.2010.01.007. Epub 2010 Mar 16.

  PMID: 20236659 BACKGROUND

• Murphy MC, McCarthy LK, O'Donnell CPF. Crying and breathing by new-born preterm infants after early or delayed cord clamping. Arch Dis Child Fetal Neonatal Ed. 2020 May;105(3):331-333. doi: 10.1136/archdischild-2018-316592. Epub 2019 May 13.

  PMID: 31085675 BACKGROUND

• Katheria A, Arnell K, Brown M, Hassen K, Maldonado M, Rich W, Finer N. A pilot randomized controlled trial of EKG for neonatal resuscitation. PLoS One. 2017 Nov 3;12(11):e0187730. doi: 10.1371/journal.pone.0187730. eCollection 2017.

  PMID: 29099872 BACKGROUND

• Kuypers KLAM, Lamberska T, Martherus T, Dekker J, Bohringer S, Hooper SB, Plavka R, Te Pas AB. The effect of a face mask for respiratory support on breathing in preterm infants at birth. Resuscitation. 2019 Nov;144:178-184. doi: 10.1016/j.resuscitation.2019.08.043. Epub 2019 Sep 12.

  PMID: 31521774 BACKGROUND

• Murphy MC, McCarthy LK, O'Donnell CPF. Initiation of respiratory support for extremely preterm infants at birth. Arch Dis Child Fetal Neonatal Ed. 2021 Mar;106(2):208-210. doi: 10.1136/archdischild-2020-319798. Epub 2020 Aug 26.

  PMID: 32847832 BACKGROUND

• Subramaniam P, Ho JJ, Davis PG. Prophylactic nasal continuous positive airway pressure for preventing morbidity and mortality in very preterm infants. Cochrane Database Syst Rev. 2016 Jun 14;(6):CD001243. doi: 10.1002/14651858.CD001243.pub3.

  PMID: 27315509 BACKGROUND

• Sandri F, Ancora G, Lanzoni A, Tagliabue P, Colnaghi M, Ventura ML, Rinaldi M, Mondello I, Gancia P, Salvioli GP, Orzalesi M, Mosca F. Prophylactic nasal continuous positive airways pressure in newborns of 28-31 weeks gestation: multicentre randomised controlled clinical trial. Arch Dis Child Fetal Neonatal Ed. 2004 Sep;89(5):F394-8. doi: 10.1136/adc.2003.037010.

  PMID: 15321956 BACKGROUND

• Goncalves-Ferri WA, Martinez FE, Caldas JP, Marba ST, Fekete S, Rugolo L, Tanuri C, Leone C, Sancho GA, Almeida MF, Guinsburg R. Application of continuous positive airway pressure in the delivery room: a multicenter randomized clinical trial. Braz J Med Biol Res. 2014 Feb;47(3):259-64. doi: 10.1590/1414-431X20133278. Epub 2014 Jan 29.

  PMID: 24554040 BACKGROUND

• Chernick V, Avery ME. Response of premature infants with periodic breathing to ventilatory stimuli. J Appl Physiol. 1966 Mar;21(2):434-40. doi: 10.1152/jappl.1966.21.2.434. No abstract available.

  PMID: 5949048 BACKGROUND

• Dolfin T, Duffty P, Wilkes D, England S, Bryan H. Effects of a face mask and pneumotachograph on breathing in sleeping infants. Am Rev Respir Dis. 1983 Dec;128(6):977-9. doi: 10.1164/arrd.1983.128.6.977.

  PMID: 6650989 BACKGROUND

• Fleming PJ, Levine MR, Goncalves A. Changes in respiratory pattern resulting from the use of a facemask to record respiration in newborn infants. Pediatr Res. 1982 Dec;16(12):1031-4. doi: 10.1203/00006450-198212000-00013.

  PMID: 7155672 BACKGROUND

• Ramet J, Praud JP, D'Allest AM, Dehan M, Gaultier C. Trigeminal airstream stimulation. Maturation-related cardiac and respiratory responses during REM sleep in human infants. Chest. 1990 Jul;98(1):92-6. doi: 10.1378/chest.98.1.92.

  PMID: 2361419 BACKGROUND

• van Vonderen JJ, Kleijn TA, Schilleman K, Walther FJ, Hooper SB, te Pas AB. Compressive force applied to a manikin's head during mask ventilation. Arch Dis Child Fetal Neonatal Ed. 2012 Jul;97(4):F254-8. doi: 10.1136/archdischild-2011-300336. Epub 2011 Dec 5.

  PMID: 22147285 BACKGROUND

MeSH Terms

Conditions

Infant, Premature, Diseases; Respiratory Distress Syndrome, Newborn

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Respiratory Distress Syndrome; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Colm PF O'Donnell, PhD

  National Maternity Hospital; University College Dublin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Masking of caregivers not feasible due to the nature of the intervention
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised parallel group study

Study Record Dates

• First Submitted: July 24, 2020
• First Posted: August 5, 2020
• Study Start: October 11, 2020
• Primary Completion: February 16, 2023
• Study Completion: May 9, 2023
• Last Updated: December 5, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Data will be available after the primary report of the study has been published and will be available for 5 years
• Access Criteria: Requests for data that are accompanied by a protocol that describes the nature and purpose of the study, the data that is required and how it will be analysed will be considered by the chief and principal investigators. Studies that are determined not to be contrary to partcipants' interests; and to be consistent with the purpose for which consent was given for the original study and methodologically sound may be approved

Locations

IE (1)