Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Prot-Cur 3
Study information
Scientific title
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.
Acronym
Study hypothesis
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.
Ethics approval
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.
Study design
Phase IV international multicenter randomised controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Please use the contact details below to request a patient information sheet
Condition
Respiratory distress syndrome (RDS) and gestational age less than 30 weeks
Intervention
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.
Intervention type
Drug
Phase
Phase IV
Drug names
Curosurf
Primary outcome measure
Mechanical ventilation or death within the first 5 days of life
Secondary outcome measures
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)
Overall trial start date
22/03/2007
Overall trial end date
01/08/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
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
Participant exclusion criteria
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
Recruitment start date
22/03/2007
Recruitment end date
01/08/2011
Locations
Countries of recruitment
Denmark, Sweden
Trial participating centre
Department of Pediatrics
Holbaek
4300
Denmark
Funders
Funder type
Industry
Funder name
Danish Medical Research Foundation for Region 3 (Denmark)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Cheisi Farmaceutici (Italy)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Nycomed (Denmark)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
Basic results (scientific)
Publication list