Condition category
Neonatal Diseases
Date applied
19/07/2010
Date assigned
25/10/2010
Last edited
25/10/2013
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

Consultant neonatologist
The National Maternity Hospital
Holles Street
Dublin
12
Ireland
+353 (0)1 637 3100
codonnell@nmh.ie

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NMH002

Study information

Scientific title

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

Acronym

DROPOM

Study hypothesis

Compared 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

The Ethics Committee of The National Maternity Hospital, Dublin, approved on the 22nd February 2010

Study design

Randomised active controlled parallel group 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 contact details below to request a patient information sheet

Condition

Respiratory support of preterm infants at birth

Intervention

Respiratory 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 type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Intubation and mechanical ventilation in the delivery room

Secondary outcome measures

1. 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 trial start date

19/07/2010

Overall trial end date

30/06/2012

Reason abandoned

Eligibility

Participant inclusion criteria

Infants born at The National Maternity Hospital at < 31 weeks gestation who receive respiratory support at birth

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

142

Participant exclusion criteria

Infants with congenital anomalies

Recruitment start date

19/07/2010

Recruitment end date

30/06/2012

Locations

Countries of recruitment

Ireland

Trial participating centre

Consultant neonatologist
Dublin
12
Ireland

Sponsor information

Organisation

The National Children's Research Centre (Ireland)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Research organisation

Funder name

The National Children's Research Centre (Ireland)

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

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23897911

Publication citations

  1. Results

    McCarthy LK, Twomey AR, Molloy EJ, Murphy JF, O'Donnell CP, A randomized trial of nasal prong or face mask for respiratory support for preterm newborns., Pediatrics, 2013, 132, 2, e389-95, doi: 10.1542/peds.2013-0446.

Additional files

Editorial Notes