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Respiratory support for preterm infants in the delivery room: Single nasal prong or face mask?
ISRCTN ISRCTN59061709
DOI 10.1186/ISRCTN59061709
ClinicalTrials.gov identifier
EudraCT number
Public title Respiratory support for preterm infants in the delivery room: Single nasal prong or face mask?
Scientific title Respiratory support for preterm infants in the delivery room: Single nasal prong or face mask? A randomised controlled trial
Acronym DROPOM
Serial number at source NMH002
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)
Lay summary Not provided at time of registration
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
Countries of recruitment Ireland
Disease/condition/study domain Respiratory support of preterm infants at birth
Participants - inclusion criteria Infants born at The National Maternity Hospital at < 31 weeks gestation who receive respiratory support at birth
Participants - exclusion criteria Infants with congenital anomalies
Anticipated start date 19/07/2010
Anticipated end date 30/06/2012
Status of trial Completed
Patient information material Not available in web format, please use contact details below to request a patient information sheet
Target number of participants 142
Interventions 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.
Primary outcome measure(s) Intubation and mechanical ventilation in the delivery room
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
Sources of funding The National Children's Research Centre (Ireland)
Trial website
Publications 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23897911
Contact name Dr  Colm  O'Donnell
  Address Consultant neonatologist
The National Maternity Hospital
Holles Street
  City/town Dublin
  Zip/Postcode 12
  Country Ireland
  Tel +353 (0)1 637 3100
  Fax +353 (0)1 661 4623
  Email codonnell@nmh.ie
Sponsor The National Children's Research Centre (Ireland)
  Address Our Lady's Children's Hospital
Crumlin
  City/town Dublin
  Zip/Postcode 12
  Country Ireland
Date applied 19/07/2010
Last edited 25/10/2013
Date ISRCTN assigned 25/10/2010
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