Creating and maintaining functional residual capacity in preterm neonates with Respiratory Distress Syndrome (RDS)
| ISRCTN | ISRCTN12757724 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12757724 |
| Secondary identifying numbers | N/A |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 03/08/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Arjan B. Pas, te
Scientific
Scientific
Department of Pediatrics, Leiden University Medical Center, J6-S, P.O. Box 9600
Leiden
2300 RC
Netherlands
| Phone | +31 (0)71 5262909 |
|---|---|
| a.b.te_pas@lumc.nl |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study acronym | EFURCI |
| Study objectives | A sustained inflation with a mechanical device and early nasal continuous positive airway pressure is a more effective management strategy for RDS in preterm infants than conventional intervention with a self-inflating mask and bag, and reduces the requirement for mechanical ventilation and surfactant treatment. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Respiratory Distress Syndrome, Preterm neonates |
| Intervention | Resuscitation at birth when necessary: Group A: Prolonged inflation of 10 seconds with a mechanical device (Neopuff t-piece resuscitator) and early CPAP treatment. Group B: Inflation with self-inflating mask and bag conform international resuscitation guidelines. |
| Intervention type | Other |
| Primary outcome measure | Need of endotracheal intubation within 3 days after birth. |
| Secondary outcome measures | 1. Death 2. Bronchopulmonary Dysplasia (BPD) |
| Overall study start date | 01/04/2005 |
| Completion date | 01/07/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Not Specified |
| Target number of participants | 200 |
| Key inclusion criteria | 1. Preterm neonates 2. Gestational age range 25 - 32 weeks (more than 24 weeks and 6 days and not more than 32 weeks and 6 days) |
| Key exclusion criteria | Antenatal diagnosed congenital anomalies of the cardio or respiratory system or anomalies incompatible with survival. |
| Date of first enrolment | 01/04/2005 |
| Date of final enrolment | 01/07/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Department of Pediatrics, Leiden University Medical Center, J6-S, P.O. Box 9600
Leiden
2300 RC
Netherlands
2300 RC
Netherlands
Sponsor information
Leiden University Medical Centre (LUMC) (Netherlands)
University/education
University/education
Albinusdreef 2
P.O. Box 9600
Leiden
2300 RC
Netherlands
| Website | http://www.lumc.nl/ |
|---|---|
"ROR" |
https://ror.org/027bh9e22 |
Funders
Funder type
Hospital/treatment centre
Leiden University Medical Centre (The Netherlands)
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 | 01/08/2007 | Yes | No |
