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

ISRCTN ISRCTN43000196
DOI https://doi.org/10.1186/ISRCTN43000196
Secondary identifying numbers IRL/09/01
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

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleNasal prongs versus nasal mask for continuous positive airways pressure (CPAP) in preterm infants: a randomised controlled trial
Study acronymThe POM trial
Study objectivesGiving 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) studiedRespiratory distress of newborn
InterventionInfants 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 typeOther
Primary outcome measureIntubation 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
Secondary outcome measures1. 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
Overall study start date22/07/2009
Completion date31/12/2010

Eligibility

Participant type(s)Patient
Age groupNeonate
SexBoth
Target number of participants120
Key inclusion criteria1. 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 criteriaInfants with congenital anomalies
Date of first enrolment22/07/2009
Date of final enrolment31/12/2010

Locations

Countries of recruitment

  • Ireland

Study participating centre

Department of Neonatology
Dublin
2
Ireland

Sponsor information

The National Children's Research Centre (Ireland)
Research organisation

Our Lady's Children's Hospital
Crumlin
Dublin
12
Ireland

cblanco@nmh.ie
http://www.childrensresearchcentre.org/index.html
ROR logo https://ror.org/025qedy81

Funders

Funder type

Hospital/treatment centre

Our Lady's Children's Hospital (Ireland) - The Children’s Research Centre

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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
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