Condition category
Respiratory
Date applied
28/03/2006
Date assigned
08/05/2006
Last edited
28/06/2011
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 Henrik Verder

ORCID ID

Contact details

Department of Pediatrics
Holbaek University Hospital
Holbaek
4300
Denmark

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 measures

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

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

Sponsor information

Organisation

Individual Sponsor (Denmark)

Sponsor details

Henrik Verder MD
PhD
Head of the Neonatal Ward
Department of Pediatrics
Holbaek University Hospital
Smedelundsgade 60
Holbaek
4300
Denmark

Sponsor type

University/education

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes