Condition category
Neonatal Diseases
Date applied
25/02/2008
Date assigned
27/03/2008
Last edited
12/06/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Angela Kribs

ORCID ID

Contact details

University of Cologne
Clinic for Paediatrics
Cologne
D-50937
Germany
+49 (0)221 478 5998
angela.kribs@uk-koeln.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00751959

Protocol/serial number

Uni-Koeln-439

Study information

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

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

Ethics Committee of the University of Cologne – submission pending

Study design

Prospective randomised controlled multi-centre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/08/2008

Overall trial end date

21/06/2012

Reason abandoned

Eligibility

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 type

Patient

Age group

Neonate

Gender

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 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

Trial participating centre

University of Cologne
Cologne
D-50937
Germany

Sponsor information

Organisation

University of Cologne (Germany)

Sponsor details

c/o Prof. Dr. Bernhard Roth
Clinic for Paediatrics
Kerpener Str. 62
Cologne
D-50937
Germany
+49 (0)221 478 5064
bernhard.roth@uk-koeln.de

Sponsor type

University/education

Website

http://www.uni-koeln.de

Funders

Funder type

Government

Funder name

Bundesministerium für Bildung und Forschung

Alternative name(s)

Federal Ministry of Education and Research, BMBF

Funding Body Type

government organisation

Funding Body Subtype

federal

Location

Germany

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26053341

Publication citations

Additional files

Editorial Notes