Prongs or mask for nasal continuous positive airway pressure (CPAP) in preterm infants

ISRCTN	ISRCTN43000196
DOI	https://doi.org/10.1186/ISRCTN43000196
Protocol serial number	IRL/09/01
Sponsor	The National Children's Research Centre (Ireland)
Funder	Our Lady's Children's Hospital (Ireland) - The Childrens Research Centre

Submission date: 21/07/2009
Registration date: 02/09/2009
Last edited: 05/11/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Colm O'Donnell
Scientific

Department of Neonatology
The National Maternity Hospital
Holles Street
Dublin
2
Ireland

Phone	+353 (0)1 637 3100
Email	codonnell@nmh.ie

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Nasal prongs versus nasal mask for continuous positive airways pressure (CPAP) in preterm infants: a randomised controlled trial
Study acronym	The POM trial
Study objectives	Giving nasal continuous positive airway pressure (CPAP) to preterm infants with prongs is more effective than with a nasal mask.
Ethics approval(s)	Research and Ethics Committee of the National Maternity Hospital, Holles Street, Dublin, Ireland approved on the 14th July 2009
Health condition(s) or problem(s) studied	Respiratory distress of newborn
Intervention	Infants starting nasal continuous positive airway pressure (CPAP) using either the Infant Flow Driver or Infant flow SiPAP machine (both made by Viasys Healthcare, Yorba Linda CA, USA) in the neonatal intensive care unit (NICU) will be randomised to receive CPAP with either short binasal prongs or nasal mask of appropriate size. Infants will receive CPAP with the randomly assigned interface for the duration of CPAP treatment, which will be determined by the care givers. Infants will be followed up until death or hospital discharge.
Intervention type	Other
Primary outcome measure(s)	Intubation and mechanical ventilation less than or equal to 72 hours of starting treatment, indicated by at least two of the five criteria: 1. Worsening clinical respiratory distress 2. Recurrent apnoeic episodes 3. Oxygen requirement greater than 40% to keep oxygen saturations greater than 85% for greater than 30 minutes 4. pH less than 7.2 on two blood gases at least 30 minutes apart 5. Carbon dioxide (PCO2) greater than 9kPa on two blood gases at least 30 minutes apart
Key secondary outcome measure(s)	1. Use of nasal intermittent positive pressure ventilation (NIPPV), measured at death or hospital discharge 2. Duration of NIPPV (days), measured at death or hospital discharge 3. Number of intubations, measured at death or hospital discharge 4. Doses of surfactant given, measured at death or hospital discharge 5. Duration of mechanical ventilation (in days and hours), measured at death or hospital discharge 6. Duration of CPAP (in days and hours), measured at death or hospital discharge 7. Duration of oxygen therapy (days), measured at death or hospital discharge 8. Oxygen therapy at 28 days 9. Oxygen therapy at 36 weeks' post-menstrual age 10. Highest persistent oxygen requirement on CPAP, measured at death or hospital discharge 11. Home oxygen therapy, measured at hospital discharge 12. Air leaks, measured at death or hospital discharge 13. Use of diuretics, measured at death or hospital discharge 14. Duration of diuretic therapy, measured at death or hospital discharge 15. Sepsis (blood, urine or cerebrospinal fluid culture positivity), measured at death or hospital discharge 16. Medical treatment for patent ductus arteriosus, measured at death or hospital discharge 17. Ligation of patent ductus arteriosus, measured at death or hospital discharge 18. Time to 120 ml/kg/day enteral feeds, measured at death or hospital discharge 19. Gastrointestinal perforation, measured at death or hospital discharge 20. Necrotising enterocolitis, measured at death or hospital discharge 21. Intraventricular haemorrhage, measured at death or hospital discharge 22. Periventricular leukomalacia, measured at death or hospital discharge 23. Retinopathy of prematurity, measured at death or hospital discharge 24. Duration of hospital stay (days), measured at death or hospital discharge 25. Death before discharge and at latest follow-up
Completion date	31/12/2010

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	All
Target sample size at registration	120
Key inclusion criteria	1. Infants born less than or equal to 30 weeks' gestation by best obstetric estimate, either sex 2. Receive nasal CPAP using the Infant Flow Driver or SiPAP machine (Viasys, Yorba Linda CA, USA) in the neonatal intensive care unit
Key exclusion criteria	Infants with congenital anomalies
Date of first enrolment	22/07/2009
Date of final enrolment	31/12/2010

Locations

Countries of recruitment

Ireland

Study participating centre

Department of Neonatology

Dublin
2
Ireland

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/11/2012		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes