A Phase 4 interventional study of Curosurf and Air in Infant, Premature, Diseases, Respiratory Distress Syndrome, Newborn and Bronchopulmonary Dysplasia, sponsored by Jean Michel Hascoet. Completed at 13 sites in France. Open to participants aged 12 Days to 16 Days. Per ClinicalTrials.gov, last updated 2022-08-24.
Sponsored by Jean Michel Hascoet · Phase 4, Interventional, and Treatment
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.
1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.
This study's enrollment of 118 is above the median of 60 across 961 interventional studies indexed under Respiratory Distress Syndrome.
Browse Respiratory Distress Syndrome studies →Jean Michel Hascoet is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
2.5 ml/kg of Surfactant will be instilled in the trachea
Drug: Curosurf
2.5 ml/kg of Air will be instilled in the trachea
Other: Air
2.5 ml/kg instilled in the trachea
2.5ml/kg of Air will be instilled in the trachea
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
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Respiratory Distress Syndrome→
Jean Michel Hascoet