'Early selective treatment of RDS with Curosurf guided by lamellar body counts

ISRCTN	ISRCTN41781424
DOI	https://doi.org/10.1186/ISRCTN41781424
Protocol serial number	Prot-Cur 3
Sponsor	Individual Sponsor (Denmark)
Funders	Danish Medical Research Foundation for Region 3 (Denmark), Cheisi Farmaceutici (Italy), Nycomed (Denmark)

Submission date: 28/03/2006
Registration date: 08/05/2006
Last edited: 28/06/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Henrik Verder
Scientific

Department of Pediatrics
Holbaek University Hospital
Holbaek
4300
Denmark

Study information

Primary study design	Interventional
Study design	Phase IV international multicenter randomised controlled study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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.
Study objectives	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(s)	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.
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Curosurf
Primary outcome measure(s)	Mechanical ventilation or death within the first 5 days of life
Key secondary outcome measure(s)	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)
Completion date	01/08/2011

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	All
Target sample size at registration	380
Key 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
Key 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
Date of first enrolment	22/03/2007
Date of final enrolment	01/08/2011

Locations

Countries of recruitment

Denmark
Sweden

Study participating centre

Department of Pediatrics

Holbaek
4300
Denmark

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?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes