Surfactant application during spontaneous breathing in premature infants <27 weeks

Surfactant application during spontaneous breathing with continuous positive airway pressure (CPAP) or during mechanical ventilation in the therapy of infant respiratory distress syndrome (IRDS) in premature infants <27 weeks

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN64011614

Enrollment

210

Registered

2008-03-27

Start date

2008-08-01

Completion date

Unknown

Last updated

2016-10-17

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

Conditions

Mortality and chronic lung disease in very immature infants Neonatal Diseases Respiratory distress of newborn

Interventions

Experimental intervention: Surfactant application via a thin endotracheal catheter during spontaneous breathing with CPAP, followed by respiratory support with CPAP Control intervention: Conventional

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Gender: both 2. IRDS with Silverman-Score >= 5 and/or FiO2 >= 0.3 3. Postnatal age of more than 10 min and less than 2 hours 4. Gestational age >= 23+0 and <27+0 weeks

Exclusion criteria

Exclusion criteria: 1. Primary cardio-pulmonary resuscitation 2. Prenatally diagnosed severe malformation 3. No parental consent 4. Participation in another interventional trial

Design outcomes

Primary

Measure	Time frame
Survival until term without CLD	—

Secondary

Measure	Time frame
The following will be followed up until 36 weeks of gestational age: 1. Survival until term without CLD, intraventricular hemorrhage (IVH)> grade II, cystic periventricular leukomalacia (PVL), retinopathy of prematurity (ROP) with need for surgery 2. Air leak syndrome (pneumothorax, pneumopericardium, pulmonary interstitial emphysema) 3. Necrotizing enterocolitis (NEC) with need for surgery 4. IVH (all grades) 5. Cystic PVL 6. ROP with need for surgery 7. Persistent ductus arteriosus (PDA) with need for surgery 8. Intubation and any mechanical ventilation during the first 96 hours 9. Days on mechanical ventilation 10. Days on nasal CPAP (nCPAP) 11. Days on supplemental oxygen 12. Duration of hospital stay 13. Daily increase in body weight	—

Measure

Time frame

The following will be followed up until 36 weeks of gestational age: 1. Survival until term without CLD, intraventricular hemorrhage (IVH)> grade II, cystic periventricular leukomalacia (PVL), retinopathy of prematurity (ROP) with need for surgery 2. Air leak syndrome (pneumothorax, pneumopericardium, pulmonary interstitial emphysema) 3. Necrotizing enterocolitis (NEC) with need for surgery 4. IVH (all grades) 5. Cystic PVL 6. ROP with need for surgery 7. Persistent ductus arteriosus (PDA) with need for surgery 8. Intubation and any mechanical ventilation during the first 96 hours 9. Days on mechanical ventilation 10. Days on nasal CPAP (nCPAP) 11. Days on supplemental oxygen 12. Duration of hospital stay 13. Daily increase in body weight

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Countries

Germany

Outcome results

None listed

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