Respiratory support for preterm infants in the delivery room: Single nasal prong or face mask?

ISRCTN ISRCTN59061709
DOI https://doi.org/10.1186/ISRCTN59061709
Secondary identifying numbers NMH002
Submission date
19/07/2010
Registration date
25/10/2010
Last edited
25/10/2013
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Neonatal Diseases
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

Consultant neonatologist
The National Maternity Hospital
Holles Street
Dublin
12
Ireland

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

Study information

Study designRandomised active controlled parallel group 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 contact details below to request a patient information sheet
Scientific titleRespiratory support for preterm infants in the delivery room: Single nasal prong or face mask? A randomised controlled trial
Study acronymDROPOM
Study objectivesCompared to preterm infants given respiratory support via a face mask, fewer premature infants given respiratory support via a single nasal prong are intubated and mechanically ventilated in the delivery room (DR)
Ethics approval(s)The Ethics Committee of The National Maternity Hospital, Dublin, approved on the 22nd February 2010
Health condition(s) or problem(s) studiedRespiratory support of preterm infants at birth
InterventionRespiratory support with a T-piece device using a single nasal prong (AKA short nasal tube AKA nasopharyngeal tube) compared to respiratory support with a T-piece device using a face mask.
Intervention typeOther
Primary outcome measureIntubation and mechanical ventilation in the delivery room
Secondary outcome measures1. Heart rate at five minutes
2. Use of supplemental oxygen in the DR
3. Chest compressions in the DR
4. Use of adrenaline and volume resuscitation in the delivery room
5. Apgar scores at 5 and 10 minutes
6. Temperature on arrival to NICU
7. Air leak (pneumothorax, pneumopericardium)
8. Intubation and mechanical ventilation ≤72 hours of life
9. Intubation and mechanical ventilation during hospital stay
10. Surfactant use
11. Duration of mechanical ventilation (hours & days)
12. Duration of CPAP (hours & days)
13. Duration of oxygen therapy (hours & days)
14. Oxygen therapy at 28 days
15. Oxygen therapy at 36 weeks’ post-menstrual age
16. Pulmonary haemorrhage
17. Pulmonary Interstitial Emphysema
18. Medical treatment for patent ductus arteriosus (PDA)
19. Surgical treatment for PDA
20. Treatment with postnatal corticosteroids
21. Intraventricular haemorrhage
22. Periventricular leukomalacia
23. Sepsis
24. Necrotising Enterocolitis
25. Retinopathy of prematurity
26. Hospital days
27. Death before hospital discharge
Overall study start date19/07/2010
Completion date30/06/2012

Eligibility

Participant type(s)Patient
Age groupNeonate
SexBoth
Target number of participants142
Key inclusion criteriaInfants born at The National Maternity Hospital at < 31 weeks gestation who receive respiratory support at birth
Key exclusion criteriaInfants with congenital anomalies
Date of first enrolment19/07/2010
Date of final enrolment30/06/2012

Locations

Countries of recruitment

  • Ireland

Study participating centre

Consultant neonatologist
Dublin
12
Ireland

Sponsor information

The National Children's Research Centre (Ireland)
Hospital/treatment centre

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

ROR logo "ROR" https://ror.org/025qedy81

Funders

Funder type

Research organisation

The National Children's Research Centre (Ireland)

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 01/08/2013 Yes No