Overview

This trial is active, not recruiting.

Conditions infant, premature, diseases, respiratory distress syndrome, newborn, bronchopulmonary dysplasia
Treatments curosurf, air
Phase phase 4
Sponsor Jean Michel Hascoet
Collaborator ARAIRLOR
Start date December 2009
End date December 2012
Trial size 100 participants
Trial identifier NCT01039285, 2009-012817-23, MRU-09-02

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
2.5 ml/kg of Surfactant will be instilled in the trachea
curosurf
2.5 ml/kg instilled in the trachea
(Placebo Comparator)
2.5 ml/kg of Air will be instilled in the trachea
air
2.5ml/kg of Air will be instilled in the trachea

Primary Outcomes

Measure
duration of assisted ventilation
time frame: days

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants up to 16 days old.

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

Additional Information

Official title Exogenous Surfactant in Very Preterm Neonates Presenting With Severe Respiratory Distress in Prevention of Bronchopulmonary Dysplasia
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Maternite Regionale Universitaire.