Exogenous Surfactant in Very Preterm Neonates in Prevention of Bronchopulmonary Dysplasia (CURDYS)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
ARAIRLOR
Chiesi Farmaceutici S.p.A.
Information provided by (Responsible Party):
Jean Michel Hascoet, Maternite Regionale Universitaire
ClinicalTrials.gov Identifier:
NCT01039285
First received: December 23, 2009
Last updated: February 4, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Prematurity
Respiratory Distress Syndrome, Newborn
Bronchopulmonary Dysplasia
Drug: Curosurf
Other: Air
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Exogenous Surfactant in Very Preterm Neonates Presenting With Severe Respiratory Distress in Prevention of Bronchopulmonary Dysplasia

Resource links provided by NLM:


Further study details as provided by Maternite Regionale Universitaire:

Primary Outcome Measures:
  • duration of assisted ventilation [ Time Frame: days ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • to reduce the incidence of BPD [ Time Frame: 36 weeks post conceptional age ] [ Designated as safety issue: No ]
  • to improve the inflammatory status of the lung and to restore its capacities for healing and growth [ Time Frame: one month ] [ Designated as safety issue: No ]
  • to improve development in stature and weight, psychomotor development, and to reduce respiratory sequelae leading to re-hospitalisation [ Time Frame: 2 years of age ] [ Designated as safety issue: No ]
  • to improve height development, psychomotor development and respiratory function [ Time Frame: 7 years of age ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: December 2009
Estimated Study Completion Date: December 2019
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Surfactant instillation
2.5 ml/kg of Surfactant will be instilled in the trachea
Drug: Curosurf
2.5 ml/kg instilled in the trachea
Placebo Comparator: Placebo instillation
2.5 ml/kg of Air will be instilled in the trachea
Other: Air
2.5ml/kg of Air will be instilled in the trachea

  Eligibility

Ages Eligible for Study:   up to 16 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01039285

Locations
France
CHU Hopital Nord
Amiens, France, 80054
CHU
Angers, France, 49033
Centre Hospitalier
Arras, France, 62000
CHU Hopital Clemenceau
Caen, France, 14033
CHU hopital d'enfants
Dijon, France, 21079
Centre Hospitalier
Lens, France, 62037
CHU Hopital Jeanne de Flandre
Lille, France, 59037
CHU Hopital de la Croix Rousse
Lyon, France, 69004
APHM hopital de la conception
Marseille, France, 13385
CHI Andre Gregoire
Montreuil, France, 93105
Maternite Regionale Universitaire
Nancy, France, 54042
AP-HP Hopital Port Royal
Paris, France, 75179
CHU Hopital Gatien de Clocheville
Tours, France, 37044
Sponsors and Collaborators
Jean Michel Hascoet
ARAIRLOR
Chiesi Farmaceutici S.p.A.
Investigators
Study Director: Jean-Michel HASCOET, MD Maternite Regionale Universitaire NANCY
  More Information

No publications provided

Responsible Party: Jean Michel Hascoet, Professor, Maternite Regionale Universitaire
ClinicalTrials.gov Identifier: NCT01039285     History of Changes
Other Study ID Numbers: MRU-09-02, 2009-012817-23
Study First Received: December 23, 2009
Last Updated: February 4, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Maternite Regionale Universitaire:
Very premature infant
Surfactant
Respiratory Distress
Bronchopulmonary Dysplasia

Additional relevant MeSH terms:
Bronchopulmonary Dysplasia
Respiratory Distress Syndrome, Newborn
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Respiration Disorders
Pulmonary Surfactants
Poractant alfa
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014