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

Primary Purpose

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

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Curosurf
Air
Sponsored by
Jean Michel Hascoet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infant, Premature, Diseases focused on measuring Very premature infant, Surfactant, Respiratory Distress, Bronchopulmonary Dysplasia

Eligibility Criteria

12 Days - 16 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Hopital Nord
  • CHU
  • Centre Hospitalier
  • CHU Hopital Clemenceau
  • CHU hopital d'enfants
  • Centre Hospitalier
  • CHU Hopital Jeanne de Flandre
  • CHU Hopital de la Croix Rousse
  • APHM hopital de la conception
  • CHI Andre Gregoire
  • Maternite Regionale Universitaire
  • AP-HP Hopital Port Royal
  • CHU Hopital Gatien de Clocheville

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Surfactant instillation

Placebo instillation

Arm Description

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

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

Outcomes

Primary Outcome Measures

duration of assisted ventilation
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
to improve the inflammatory status of the lung and to restore its capacities for healing and growth
to improve development in stature and weight, psychomotor development, and to reduce respiratory sequelae leading to re-hospitalisation
to improve height development, psychomotor development and respiratory function

Full Information

First Posted
December 23, 2009
Last Updated
August 23, 2022
Sponsor
Jean Michel Hascoet
Collaborators
ARAIRLOR, Chiesi Farmaceutici S.p.A.
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1. Study Identification

Unique Protocol Identification Number
NCT01039285
Brief Title
Exogenous Surfactant in Very Preterm Neonates in Prevention of Bronchopulmonary Dysplasia
Acronym
CURDYS
Official Title
Exogenous Surfactant in Very Preterm Neonates Presenting With Severe Respiratory Distress in Prevention of Bronchopulmonary Dysplasia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
December 2009 (Actual)
Primary Completion Date
September 2021 (Actual)
Study Completion Date
June 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jean Michel Hascoet
Collaborators
ARAIRLOR, Chiesi Farmaceutici S.p.A.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant, Premature, Diseases, Respiratory Distress Syndrome, Newborn, Bronchopulmonary Dysplasia
Keywords
Very premature infant, Surfactant, Respiratory Distress, Bronchopulmonary Dysplasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
118 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Surfactant instillation
Arm Type
Experimental
Arm Description
2.5 ml/kg of Surfactant will be instilled in the trachea
Arm Title
Placebo instillation
Arm Type
Placebo Comparator
Arm Description
2.5 ml/kg of Air will be instilled in the trachea
Intervention Type
Drug
Intervention Name(s)
Curosurf
Intervention Description
2.5 ml/kg instilled in the trachea
Intervention Type
Other
Intervention Name(s)
Air
Intervention Description
2.5ml/kg of Air will be instilled in the trachea
Primary Outcome Measure Information:
Title
duration of assisted ventilation
Description
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.
Time Frame
days
Secondary Outcome Measure Information:
Title
to reduce the incidence of BPD
Time Frame
36 weeks post conceptional age
Title
to improve the inflammatory status of the lung and to restore its capacities for healing and growth
Time Frame
one month
Title
to improve development in stature and weight, psychomotor development, and to reduce respiratory sequelae leading to re-hospitalisation
Time Frame
2 years of age
Title
to improve height development, psychomotor development and respiratory function
Time Frame
7 years of age

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Days
Maximum Age & Unit of Time
16 Days
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Michel HASCOET, MD
Organizational Affiliation
Maternite Regionale Universitaire NANCY
Official's Role
Study Director
Facility Information:
Facility Name
CHU Hopital Nord
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
CHU
City
Angers
ZIP/Postal Code
49033
Country
France
Facility Name
Centre Hospitalier
City
Arras
ZIP/Postal Code
62000
Country
France
Facility Name
CHU Hopital Clemenceau
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
CHU hopital d'enfants
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Centre Hospitalier
City
Lens
ZIP/Postal Code
62037
Country
France
Facility Name
CHU Hopital Jeanne de Flandre
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
CHU Hopital de la Croix Rousse
City
Lyon
ZIP/Postal Code
69004
Country
France
Facility Name
APHM hopital de la conception
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
CHI Andre Gregoire
City
Montreuil
ZIP/Postal Code
93105
Country
France
Facility Name
Maternite Regionale Universitaire
City
Nancy
ZIP/Postal Code
54042
Country
France
Facility Name
AP-HP Hopital Port Royal
City
Paris
ZIP/Postal Code
75179
Country
France
Facility Name
CHU Hopital Gatien de Clocheville
City
Tours
ZIP/Postal Code
37044
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
26928567
Citation
Hascoet JM, Picaud JC, Ligi I, Blanc T, Moreau F, Pinturier MF, Zupan V, Guilhoto I, Hamon IR, Alexandre C, Bouissou A, Storme L, Patkai J, Pomedio M, Rouabah M, Coletto L, Vieux R. Late Surfactant Administration in Very Preterm Neonates With Prolonged Respiratory Distress and Pulmonary Outcome at 1 Year of Age: A Randomized Clinical Trial. JAMA Pediatr. 2016 Apr;170(4):365-72. doi: 10.1001/jamapediatrics.2015.4617.
Results Reference
result
PubMed Identifier
29193276
Citation
Hascoet JM, Picaud JC, Ligi I, Blanc T, Daoud P, Zupan V, Moreau F, Guilhoto I, Rouabah M, Alexandre C, Saliba E, Storme L, Patkai J, Pomedio M, Hamon I. Review shows that using surfactant a number of times or as a vehicle for budesonide may reduce the risk of bronchopulmonary dysplasia. Acta Paediatr. 2018 Jul;107(7):1140-1144. doi: 10.1111/apa.14171. Epub 2017 Dec 22.
Results Reference
result

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Exogenous Surfactant in Very Preterm Neonates in Prevention of Bronchopulmonary Dysplasia

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