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Tidlig selektiv behandling med Curosurf. Behandling af RDS efter bestemmelse af lamellar body counts på ventrikelaspirat sammenholdt med behandling ved a/APO2 <0,36 En randomiseret kontrolleret multicenterundersøgelse af børn efter 24-29 uger - Tidlig selektiv behandling med Curosurf

Tidlig selektiv behandling med Curosurf. Behandling af RDS efter bestemmelse af lamellar body counts på ventrikelaspirat sammenholdt med behandling ved a/APO2 <0,36 En randomiseret kontrolleret multicenterundersøgelse af børn efter 24-29 uger - Tidlig selektiv behandling med Curosurf

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-001563-37-SE
Enrollment
380
Registered
2010-02-25
Start date
2010-03-25
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

Respiratory Distress Syndrome (RDS) in infants 24-29 weeks`gestation

Interventions

Sponsors

Department of Pediatrics Holbaek Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. GA 24 + 0 to 29 + 9 wk 2. Early nasal CPAP 3. Gastric aspirate not later than 45 min after birth 4. Informed consent (written and orally) before birth or lates 1 h after birth Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Prolonged rupture of the membranes > 3 wk 2. Therapeutic infusions in the amniotic cave 3. Lethal malformations 4. Intubation in the delivery room 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

MeasureTime frame
Main Objective: To better the outcome of RDS including survival and survival without sequelae by very early selective treatment of infants on nasal CPAP with Curosurf.;Secondary Objective: ;Primary end point(s): Mechanical ventilation or death within the first 5 days of life

Countries

Sweden

Outcome results

None listed

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