Trial | NCT01039285  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    118
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.
Study Started
Dec 31
2009
Primary Completion
Sep 30
2021
Study Completion
Jun 30
2022
Last Update
Aug 24
2022

Drug Curosurf

2.5 ml/kg instilled in the trachea

Other Air

2.5ml/kg of Air will be instilled in the trachea

Surfactant instillation Experimental

2.5 ml/kg of Surfactant will be instilled in the trachea

Placebo instillation Placebo Comparator

2.5 ml/kg of Air will be instilled in the trachea

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
No Results Posted