Exogenous Surfactant in Very Preterm Neonates in Prevention of Bronchopulmonary Dysplasia (CURDYS)

Jean Michel Hascoet

Status and phase

Completed

Phase 4

Conditions

Infant, Premature, Diseases

Respiratory Distress Syndrome, Newborn

Bronchopulmonary Dysplasia

Treatments

Other: Air

Drug: Curosurf

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01039285

2009-012817-23 (Registry Identifier)

MRU-09-02

Details and patient eligibility

About

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.

Enrollment

118 patients

Sex

All

Ages

12 to 16 days old

Volunteers

No Healthy Volunteers

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