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ISRCTN
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ISRCTN64011614
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ClinicalTrials.gov identifier
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Public title
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Surfactant application during spontaneous breathing in premature infants <27 weeks
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Scientific title
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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
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Acronym
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NINSAPP
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Serial number at source
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Uni-Koeln-439
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Study hypothesis
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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.
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Ethics approval
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Application for ethics approval is planned for March 2008 with the Ethics Committee of the University of Cologne as of 25/02/2008.
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Study design
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Prospective randomised controlled multi-centre trial.
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Countries of recruitment
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Germany
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Disease/condition/study domain
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Mortality and chronic lung disease in very immature infants
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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1. Primary cardio-pulmonary resuscitation
2. Prenatally diagnosed severe malformation
3. No parental consent
4. Participation in another interventional trial
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Anticipated start date
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01/08/2008
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Anticipated end date
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31/07/2011
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Status of trial
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Ongoing
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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180
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Interventions
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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
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Primary outcome measure(s)
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Survival until term without CLD
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Secondary outcome measure(s)
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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
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Sources of funding
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German Federal Ministry of Education and Research (BMBF) (Germany)
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Trial website
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Publications
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Contact name
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Dr
Angela
Kribs
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Address
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University of Cologne
Clinic for Paediatrics
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City/town
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Cologne
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Zip/Postcode
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D-50937
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Country
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Germany
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Tel
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+49 221 478 5998
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Fax
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+49 221 478 6451
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Email
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angela.kribs@uk-koeln.de
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Sponsor
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University of Cologne (Germany)
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Address
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c/o Prof. Dr. Bernhard Roth
Clinic for Paediatrics
Kerpener Str. 62
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City/town
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Cologne
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Zip/Postcode
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D-50937
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Country
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Germany
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Tel
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+49 221 478 5064
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Fax
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+49 221 478 3618
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Email
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bernhard.roth@uk-koeln.de
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Sponsor website:
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http://www.uni-koeln.de
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Date applied
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25/02/2008
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Last edited
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01/04/2008
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Date ISRCTN assigned
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27/03/2008
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