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
Scientific
Consultant neonatologist
The National Maternity Hospital
Holles Street
Dublin
12
Ireland
| Phone | +353 (0)1 637 3100 |
|---|---|
| codonnell@nmh.ie |
Study information
| Study design | Randomised active controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a patient 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 | 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 study start date | 19/07/2010 |
| Completion date | 30/06/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 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
12
Ireland
Sponsor information
The National Children's Research Centre (Ireland)
Hospital/treatment centre
Hospital/treatment centre
Our Lady's Children's Hospital
Crumlin
Dublin
12
Ireland
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
