Surfactant application during spontaneous breathing in premature infants <27 weeks

ISRCTN	ISRCTN64011614
DOI	https://doi.org/10.1186/ISRCTN64011614
ClinicalTrials.gov (NCT)	NCT00751959
Protocol serial number	Uni-Koeln-439
Sponsor	University of Cologne (Germany)
Funder	Bundesministerium für Bildung und Forschung

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 of protocol

Not provided at time of registration

Contact information

Dr Angela Kribs
Scientific

University of Cologne
Clinic for Paediatrics
Cologne
D-50937
Germany

Phone	+49 (0)221 478 5998
Email	angela.kribs@uk-koeln.de

Study information

Primary study design	Interventional
Study design	Prospective randomised controlled multi-centre trial
Secondary study design	Randomised controlled trial
Study type	Participant 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 objectives	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
Health condition(s) or problem(s) studied	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(s)	Survival until term without CLD
Key secondary outcome measure(s)	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
Completion date	21/06/2012

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	All
Target sample size at registration	210
Key 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
Key exclusion criteria	1. Primary cardio-pulmonary resuscitation 2. Prenatally diagnosed severe malformation 3. No parental consent 4. Participation in another interventional trial
Date of first enrolment	01/08/2008
Date of final enrolment	25/03/2012

Locations

Countries of recruitment

Germany

Study participating centre

University of Cologne

Cologne
D-50937
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes