NCT01039285

Exogenous Surfactant in Very Preterm Neonates in Prevention of Bronchopulmonary Dysplasia

Exogenous Surfactant in Very Preterm Neonates Presenting With Severe Respiratory Distress in Prevention of Bronchopulmonary Dysplasia

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 118 (actual)
• Sponsor: Jean Michel Hascoet · Academic / Other
• Sex: All
• Age: 12 Days – 16 Days
• Healthy volunteers: Not accepted

Summary

Advances in perinatal care have made it possible to improve the survival of the most immature neonates, but at the cost of an increase in the population at risk of developing bronchopulmonary dysplasia (BPD). Measures that have attempted to limit the development of BPD are not always effective, or related to major side effects. The physiopathological factors that are identified in BPD should, in theory, respond to surfactant. Therefore, the use of an exogenous surfactant in neonates presenting with pulmonary disease requiring mechanical ventilation, leading to a significant risk of BPD, should allow earlier extubation and thus promote pulmonary healing and growth.

Conditions

• Infant, Premature, Diseases
• Respiratory Distress Syndrome, Newborn
• Bronchopulmonary Dysplasia

Interventions

Type	Name	Description
DRUG	Curosurf	2.5 ml/kg instilled in the trachea
OTHER	Air	2.5ml/kg of Air will be instilled in the trachea

Timeline

• Start date: 2009-12-01
• Primary completion: 2021-09-01
• Completion: 2022-06-01
• First posted: 2009-12-24
• Last updated: 2022-08-24

Locations

13 sites across 1 country: France