Surfactant application during spontaneous breathing in premature infants <27 weeks
| ISRCTN | ISRCTN64011614 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN64011614 |
| ClinicalTrials.gov number | NCT00751959 |
| Secondary identifying numbers | Uni-Koeln-439 |
- Submission date
- 25/02/2008
- Registration date
- 27/03/2008
- Last edited
- 12/06/2015
- 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
Not provided at time of registration
Contact information
Dr Angela Kribs
Scientific
Scientific
University of Cologne
Clinic for Paediatrics
Cologne
D-50937
Germany
| Phone | +49 (0)221 478 5998 |
|---|---|
| angela.kribs@uk-koeln.de |
Study information
| Study design | Prospective randomised controlled multi-centre 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 the contact details below to request a patient information sheet |
| Scientific title | Surfactant application during spontaneous breathing with continuous positive airway pressure (CPAP) or during mechanical ventilation in the therapy of infant respiratory distress syndrome (IRDS) in premature infants <27 weeks |
| Study acronym | NINSAPP |
| Study hypothesis | This study investigates the efficacy of surfactant application during spontaneous breathing with CPAP in avoiding death and chronic lung disease (CLD) in very immature infants with a gestational age of less than 27 weeks. On 27/03/2012, the following changes were made on the trial record: 1. The overall trial end date of trial was changed from 31/07/2011 to 31/12/2012. 2. The target number of participants has been amended from 180 to 210. On 18/07/2012 the overall trial end date was changed from 31/12/2012 to 21/06/2012. |
| Ethics approval(s) | Ethics Committee of the University of Cologne – submission pending |
| Condition | Mortality and chronic lung disease in very immature infants |
| Intervention | Experimental intervention: Surfactant application via a thin endotracheal catheter during spontaneous breathing with CPAP, followed by respiratory support with CPAP Control intervention: Conventional therapy with intubation, initiation of mechanical ventilation and surfactant application |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Survival until term without CLD |
| Secondary outcome measures | The following will be followed up until 36 weeks of gestational age: 1. Survival until term without CLD, intraventricular hemorrhage (IVH)> grade II, cystic periventricular leukomalacia (PVL), retinopathy of prematurity (ROP) with need for surgery 2. Air leak syndrome (pneumothorax, pneumopericardium, pulmonary interstitial emphysema) 3. Necrotizing enterocolitis (NEC) with need for surgery 4. IVH (all grades) 5. Cystic PVL 6. ROP with need for surgery 7. Persistent ductus arteriosus (PDA) with need for surgery 8. Intubation and any mechanical ventilation during the first 96 hours 9. Days on mechanical ventilation 10. Days on nasal CPAP (nCPAP) 11. Days on supplemental oxygen 12. Duration of hospital stay 13. Daily increase in body weight |
| Overall study start date | 01/08/2008 |
| Overall study end date | 21/06/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 210 (Due to a protocol amendment 30 more participants had to be recruited. Recruitment completed on 25/03/2012 with a total of 213 participants). |
| Participant inclusion criteria | 1. Gender: both 2. IRDS with Silverman-Score >= 5 and/or FiO2 >= 0.3 3. Postnatal age of more than 10 min and less than 2 hours 4. Gestational age >= 23+0 and <27+0 weeks |
| Participant exclusion criteria | 1. Primary cardio-pulmonary resuscitation 2. Prenatally diagnosed severe malformation 3. No parental consent 4. Participation in another interventional trial |
| Recruitment start date | 01/08/2008 |
| Recruitment end date | 25/03/2012 |
Locations
Countries of recruitment
- Germany
Study participating centre
University of Cologne
Cologne
D-50937
Germany
D-50937
Germany
Sponsor information
University of Cologne (Germany)
University/education
University/education
c/o Prof. Dr. Bernhard Roth
Clinic for Paediatrics
Kerpener Str. 62
Cologne
D-50937
Germany
| Phone | +49 (0)221 478 5064 |
|---|---|
| bernhard.roth@uk-koeln.de | |
| Website | http://www.uni-koeln.de |
"ROR" |
https://ror.org/00rcxh774 |
Funders
Funder type
Government
Bundesministerium für Bildung und Forschung
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Federal Ministry of Education and Research, BMBF
- Location
- Germany
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 | 01/08/2015 | Yes | No |
