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

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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN41781424

Enrollment

380

Registered

2006-05-08

Start date

2007-03-22

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory distress syndrome (RDS) and gestational age less than 30 weeks Respiratory Respiratory distress syndrome

Interventions

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 (

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Mechanical ventilation or death within the first 5 days of life	—

Secondary

Measure	Time frame
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)	—

Measure

Time frame

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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Countries

Denmark, Sweden

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026