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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23897911
Publication citations
-
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.