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Exogenous Surfactant in Very Preterm Neonates in Prevention of Bronchopulmonary Dysplasia

NCT01039285 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2022-08-24

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Curosurf

2.5 ml/kg instilled in the trachea

OTHER

Air

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

Sponsors & Collaborators

  • ARAIRLOR

    collaborator UNKNOWN

  • Chiesi Farmaceutici S.p.A.

    collaborator INDUSTRY

  • Jean Michel Hascoet

    lead OTHER

Principal Investigators

  • Jean-Michel HASCOET, MD · Maternite Regionale Universitaire NANCY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Days
Max Age
16 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2021-09-30
Completion
2022-06-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01039285 on ClinicalTrials.gov