Exogenous Surfactant in Very Preterm Neonates in Prevention of Bronchopulmonary Dysplasia

Study Overview
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Brief Summary
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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.

Official Title
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Exogenous Surfactant in Very Preterm Neonates Presenting With Severe Respiratory Distress in Prevention of Bronchopulmonary Dysplasia

Conditions
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Infant, Premature, Diseases, Respiratory Distress Syndrome, Newborn, Bronchopulmonary Dysplasia

Intervention / Treatment
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* Drug: Curosurf
* Other: Air


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Days
Maximum Age: 16 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Surfactant instillation<br>2.5 ml/kg of Surfactant will be instilled in the trachea | Drug: Curosurf<br>* 2.5 ml/kg instilled in the trachea<br>|
| Placebo Comparator: Placebo instillation<br>2.5 ml/kg of Air will be instilled in the trachea | Other: Air<br>* 2.5ml/kg of Air will be instilled in the trachea<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Very premature infant, Surfactant, Respiratory Distress, Bronchopulmonary Dysplasia