Condition category
Respiratory
Date applied
21/07/2009
Date assigned
02/09/2009
Last edited
05/11/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Colm O'Donnell

ORCID ID

Contact details

Department of Neonatology
The National Maternity Hospital
Holles Street
Dublin
2
Ireland
+353 (0)1 637 3100
codonnell@nmh.ie

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

IRL/09/01

Study information

Scientific title

Nasal prongs versus nasal mask for continuous positive airways pressure (CPAP) in preterm infants: a randomised controlled trial

Acronym

The POM trial

Study hypothesis

Giving nasal continuous positive airway pressure (CPAP) to preterm infants with prongs is more effective than with a nasal mask.

Ethics approval

Research and Ethics Committee of the National Maternity Hospital, Holles Street, Dublin, Ireland approved on the 14th July 2009

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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

Secondary outcome measures

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

Overall trial start date

22/07/2009

Overall trial end date

31/12/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

120

Participant exclusion criteria

Infants with congenital anomalies

Recruitment start date

22/07/2009

Recruitment end date

31/12/2010

Locations

Countries of recruitment

Ireland

Trial participating centre

Department of Neonatology
Dublin
2
Ireland

Sponsor information

Organisation

The National Children's Research Centre (Ireland)

Sponsor details

Our Lady's Children's Hospital
Crumlin
Dublin
12
Ireland
cblanco@nmh.ie

Sponsor type

Research organisation

Website

http://www.childrensresearchcentre.org/index.html

Funders

Funder type

Hospital/treatment centre

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2012 results in www.ncbi.nlm.nih.gov/pubmed/23090339

Publication citations

  1. Results

    Kieran EA, Twomey AR, Molloy EJ, Murphy JF, O'Donnell CP, Randomized trial of prongs or mask for nasal continuous positive airway pressure in preterm infants., Pediatrics, 2012, 130, 5, e1170-6, doi: 10.1542/peds.2011-3548.

Additional files

Editorial Notes