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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01039285
First Posted: December 24, 2009
Last Update Posted: August 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
ARAIRLOR
Chiesi Farmaceutici S.p.A.
Information provided by (Responsible Party):
Jean Michel Hascoet, Maternite Regionale Universitaire
  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
Infant, Premature, Diseases Respiratory Distress Syndrome, Newborn Bronchopulmonary Dysplasia Drug: Curosurf Other: Air Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 Jean Michel Hascoet, Maternite Regionale Universitaire:

Primary Outcome Measures:
  • duration of assisted ventilation [ Time Frame: days ]
    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 ]
  • 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 ]

Estimated Enrollment: 100
Actual 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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 16 Days   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 ( Registry Identifier: EUDRACT )
First Submitted: December 23, 2009
First Posted: December 24, 2009
Last Update Posted: August 29, 2017
Last Verified: August 2017

Keywords provided by Jean Michel Hascoet, Maternite Regionale Universitaire:
Very premature infant
Surfactant
Respiratory Distress
Bronchopulmonary Dysplasia

Additional relevant MeSH terms:
Hyperplasia
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Bronchopulmonary Dysplasia
Infant, Premature, Diseases
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Newborn, Diseases
Ventilator-Induced Lung Injury
Lung Injury
Pulmonary Surfactants
Poractant alfa
Respiratory System Agents