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

ISRCTN	ISRCTN59061709
DOI	https://doi.org/10.1186/ISRCTN59061709
Protocol serial number	NMH002
Sponsor	The National Children's Research Centre (Ireland)
Funder	The National Children's Research Centre (Ireland)

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

Primary study design	Interventional
Study design	Randomised active controlled parallel group trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Respiratory support for preterm infants in the delivery room: Single nasal prong or face mask? A randomised controlled trial
Study acronym	DROPOM
Study objectives	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(s)	The Ethics Committee of The National Maternity Hospital, Dublin, approved on the 22nd February 2010
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Intubation and mechanical ventilation in the delivery room
Key secondary outcome measure(s)	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
Completion date	30/06/2012

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	All
Target sample size at registration	142
Key inclusion criteria	Infants born at The National Maternity Hospital at < 31 weeks gestation who receive respiratory support at birth
Key exclusion criteria	Infants with congenital anomalies
Date of first enrolment	19/07/2010
Date of final enrolment	30/06/2012

Locations

Countries of recruitment

Ireland

Study participating centre

Consultant neonatologist

Dublin
12
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	01/08/2013		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes