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ISRCTN
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ISRCTN41781424
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ClinicalTrials.gov identifier
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Public title
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'Early selective treatment of RDS with Curosurf guided by lamellar body counts
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Scientific title
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Early selective treatment with Curosurf. Treatment of respiratory distress syndrome with Curosurf guided by lamellar body counts on gastric aspirate compared to treatment at arterial to alveolar oxygen tension ratio (a/APO2) <0.36. A Danish-Swedish randomised controlled study in infants at 24-29 weeks of gestation.
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Acronym
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N/A
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Serial number at source
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Prot-Cur 3
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Study hypothesis
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Early treatment with surfactant betters the outcome of respiratory distress syndrome (RDS). However, only about half of preterm infants less than 30 week-gestation need surfactant when supported by early nasal continuous positive airway pressure (CPAP) or mechanical ventilation. Therefore, there is a need for a rapid and easily accessible method to predict RDS. Lamellar body counts (LBC) on gastric aspirate using automatic blood cell counters have been shown to fulfil this condition.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Research Ethics Committee of the Videnskabsetiske Committee for Bornhoms Regionskommune and Frederiksborg, Roskilde, Storstroms and Vestsjaelands Amter on 31/01/2006, (ref: Ø-2006-2-02G). All suction procedures for gastric aspirate were secure and tested. There were no serious adverse effects of Curosurf. All infants with RDS will receive Curosurf later as in our classical regiment and we have had very good results with this regiment.
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Study design
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Phase IV international multicenter randomised controlled study
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Countries of recruitment
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Denmark, Sweden
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Disease/condition/study domain
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Respiratory distress syndrome (RDS) and gestational age less than 30 weeks
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Participants - inclusion criteria
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1. Gastric aspirate (GA) 24 + 0 to 29 + 9 weeks
2. Early nasal CPAP
3. Gastric aspirate obtained not later than 45 min after birth
4. Informed consent before birth or latest 1 h after birth
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Participants - exclusion criteria
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1. Prolonged rupture of the membranes >3 weeks
2. Therapeutic infusions in the amniotic cave
3. Lethal malformations
4. Intubation in the delivery room or before randomisation
5. Meconium or pus contamination of the gastric aspirate
6. The neonatal ward too busy with other patients
7. No gastric aspirate
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Anticipated start date
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22/03/2007
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Anticipated end date
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01/08/2011
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Status of trial
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Completed |
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Patient information material
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Please use the contact details below to request a patient information sheet
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Target number of participants
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Prior to 24/09/09: 260. Interim calculation after 130 patients
Amended 24/09/09: 380. Interim calculation after 190 patients
Last Patient included on 26/04/2011
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Interventions
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Randomisation to:
1. Selective treatment with Curosurf 200 mg/kg (intubation and extubation) 1-2 h after birth, guided by LBC
2. Classical Scandinavian regimen i.e. treatment with Curosurf 200 mg/kg (intubation and extubation) 5-6 h after birth when a/APO2 decreases below 0.36
Trial start and end dates were amended on 24/09/09 (used to be 01/09/06 to 01/03/08).
As of 28/06/2011 the end date has again been extended from 31/12/2010 to 01/08/2011.
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Primary outcome measure(s)
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Mechanical ventilation or death within the first 5 days of life
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Secondary outcome measure(s)
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1. Mortality before discharge
2. a/APO2 after 6 days
3. Mechanical ventilation before discharge
4. Pneumothorax
5. Lung haemorrhage
6. Diastolic arterial pressure (DAP)
7. Necrotising enterocolitis (NEC)
8. Chronic lung disease (CLD) or bronchopulmonary dysplasia (BPD)
9. Intraventricular hemorrhage (IVH)
10. Periventricular leukomalacia (PVL)
11. Retinopathy of prematurity (ROP)
12. Duration of oxygen treatment (days)
13. Duration of nasal CPAP (days)
14. Duration of mechanical ventilation (days)
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Sources of funding
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1. Danish Medical Research Foundation for Region 3 (Denmark)
2. Cheisi Farmaceutici (Italy)
3. Nycomed (Denmark)
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Trial website
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Publications
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Contact name
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Dr
Henrik
Verder
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Address
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Department of Pediatrics
Holbaek University Hospital
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City/town
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Holbaek
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Zip/Postcode
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4300
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Country
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Denmark
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Sponsor
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Individual Sponsor (Denmark)
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Address
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Henrik Verder MD, PhD
Head of the Neonatal Ward
Department of Pediatrics
Holbaek University Hospital
Smedelundsgade 60
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City/town
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Holbaek
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Zip/Postcode
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4300
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Country
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Denmark
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Date applied
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28/03/2006
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Last edited
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28/06/2011
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Date ISRCTN assigned
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08/05/2006
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