Clinical trial NCT01039285: Exogenous Surfactant in Very Preterm Neonates in Prevention of Bronchopulmonary Dysplasia
Official title: Exogenous Surfactant in Very Preterm Neonates Presenting With Severe Respiratory Distress in Prevention of Bronchopulmonary Dysplasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infant, Premature, Diseases
Respiratory Distress Syndrome, Newborn
Bronchopulmonary Dysplasia
Keywords: Very premature infant
Surfactant
Respiratory Distress
Bronchopulmonary Dysplasia
Lead sponsor: Maternite Regionale Universitaire
Sponsor class: OTHER
Collaborators: name: ARAIRLOR
name: Chiesi Farmaceutici S.p.A.
First posted: 2009-12-24
Enrollment: 118
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: duration of assisted ventilation
timeFrame: days
Secondary outcomes:
measure: to reduce the incidence of BPD
timeFrame: 36 weeks post conceptional age
measure: to improve the inflammatory status of the lung and to restore its capacities for healing and growth
timeFrame: one month
measure: to improve development in stature and weight, psychomotor development, and to reduce respiratory sequelae leading to re-hospitalisation
timeFrame: 2 years of age
measure: to improve height development, psychomotor development and respiratory function
timeFrame: 7 years of age
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Hopital Nord
city: Angers
country: France
facility: CHU
city: Arras
country: France
facility: Centre Hospitalier
city: Caen
country: France
facility: CHU Hopital Clemenceau
city: Dijon
country: France
facility: CHU hopital d'enfants
city: Lens
country: France
facility: Centre Hospitalier
city: Lille
country: France
facility: CHU Hopital Jeanne de Flandre
city: Lyon
country: France
facility: CHU Hopital de la Croix Rousse
city: Marseille
country: France
facility: APHM hopital de la conception
city: Montreuil
country: France
facility: CHI Andre Gregoire
city: Nancy
country: France
facility: Maternite Regionale Universitaire
city: Paris
country: France
facility: AP-HP Hopital Port Royal
city: Tours
country: France
facility: CHU Hopital Gatien de Clocheville
Study officials:
affiliation: Maternite Regionale Universitaire NANCY
name: Jean-Michel HASCOET, MD
role: STUDY_DIRECTOR
References:
citation: Hascoet JM, Picaud JC, Ligi I, Blanc T, Moreau F, Pinturier MF, Zupan V, Guilhoto I, Hamon IR, Alexandre C, Bouissou A, Storme L, Patkai J, Pomedio M, Rouabah M, Coletto L, Vieux R. Late Surfactant Administration in Very Preterm Neonates With Prolonged Respiratory Distress and Pulmonary Outcome at 1 Year of Age: A Randomized Clinical Trial. JAMA Pediatr. 2016 Apr;170(4):365-72. doi: 10.1001/jamapediatrics.2015.4617.
citation: Hascoet JM, Picaud JC, Ligi I, Blanc T, Daoud P, Zupan V, Moreau F, Guilhoto I, Rouabah M, Alexandre C, Saliba E, Storme L, Patkai J, Pomedio M, Hamon I. Review shows that using surfactant a number of times or as a vehicle for budesonide may reduce the risk of bronchopulmonary dysplasia. Acta Paediatr. 2018 Jul;107(7):1140-1144. doi: 10.1111/apa.14171. Epub 2017 Dec 22.