Bronchopulmonary Dysplasia, Infant, Premature, Diseases, Respiratory Distress Syndrome, Newborn
Conditions
Keywords
Very premature infant, Surfactant, Respiratory Distress, Bronchopulmonary Dysplasia
Brief 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.
Interventions
DRUGCurosurf
2.5 ml/kg instilled in the trachea
OTHERAir
2.5ml/kg of Air will be instilled in the trachea
Sponsors
ARAIRLOR
Chiesi Farmaceutici S.p.A.
Jean Michel Hascoet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Days to 16 Days
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| duration of assisted ventilation | days | 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. |
Secondary
| Measure | Time frame |
|---|---|
| to reduce the incidence of BPD | 36 weeks post conceptional age |
| to improve the inflammatory status of the lung and to restore its capacities for healing and growth | one month |
| to improve development in stature and weight, psychomotor development, and to reduce respiratory sequelae leading to re-hospitalisation | 2 years of age |
| to improve height development, psychomotor development and respiratory function | 7 years of age |
Countries
France
Outcome results
None listed