Exogenous Surfactant in Very Preterm Neonates in Prevention of Bronchopulmonary Dysplasia

• Status: Active, not recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jean Michel Hascoet
• Collaborators: ARAIRLOR; Chiesi Farmaceutici S.p.A.
• Treatments: Poractant alfa; Pulmonary Surfactants

Criteria

Inclusion Criteria:

• any neonate of gestational age less than 33 weeks of amenorrhea still on conventional assisted ventilation or HFOV (High Frequency Oscillatory Ventilation), after 14 ± 2 days of life

Exclusion Criteria:

• active infection (CRP > 30 mg/L) not controlled by appropriate antibiotic treatment

• use of corticosteroids in the postnatal period

• significant neurological or malformative disease

• surgical intervention < 72 hours

• refusal of parental approval