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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
118
CHU Hopital Nord
Amiens, France
CHU
Angers, France
Centre Hospitalier
Arras, France
CHU Hopital Clemenceau
Caen, France
CHU hopital d'enfants
Dijon, France
Centre Hospitalier
Lens, France
CHU Hopital Jeanne de Flandre
Lille, France
CHU Hopital de la Croix Rousse
Lyon, France
APHM hopital de la conception
Marseille, France
CHI Andre Gregoire
Montreuil, France
...and 3 more locations
duration of assisted ventilation
we aim to demonstrate a significant reduction in the duration of assisted ventilation in children presenting with severe respiratory distress at 14+/-2 days of life.
Time frame: days
to reduce the incidence of BPD
Time frame: 36 weeks post conceptional age
to improve the inflammatory status of the lung and to restore its capacities for healing and growth
Time frame: one month
to improve development in stature and weight, psychomotor development, and to reduce respiratory sequelae leading to re-hospitalisation
Time frame: 2 years of age
to improve height development, psychomotor development and respiratory function
Time frame: 7 years of age
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