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Exogenous Surfactant in Very Preterm Neonates in Prevention of Bronchopulmonary Dysplasia

NCT ID: NCT01039285

Last Updated: 2022-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2022-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Surfactant instillation

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

Group Type EXPERIMENTAL

Curosurf

Intervention Type DRUG

2.5 ml/kg instilled in the trachea

Placebo instillation

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

Group Type PLACEBO_COMPARATOR

Air

Intervention Type OTHER

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

Interventions

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Curosurf

2.5 ml/kg instilled in the trachea

Intervention Type DRUG

Air

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

12 Days

Maximum Eligible Age

16 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ARAIRLOR

UNKNOWN

Sponsor Role collaborator

Chiesi Farmaceutici S.p.A.

INDUSTRY

Sponsor Role collaborator

Jean Michel Hascoet

OTHER

Sponsor Role lead

Responsible Party

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Jean Michel Hascoet

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jean-Michel HASCOET, MD

Role: STUDY_DIRECTOR

Maternite Regionale Universitaire NANCY

Locations

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CHU Hopital Nord

Amiens, , France

Site Status

CHU

Angers, , France

Site Status

Centre Hospitalier

Arras, , France

Site Status

CHU Hopital Clemenceau

Caen, , France

Site Status

CHU hopital d'enfants

Dijon, , France

Site Status

Centre Hospitalier

Lens, , France

Site Status

CHU Hopital Jeanne de Flandre

Lille, , France

Site Status

CHU Hopital de la Croix Rousse

Lyon, , France

Site Status

APHM hopital de la conception

Marseille, , France

Site Status

CHI Andre Gregoire

Montreuil, , France

Site Status

Maternite Regionale Universitaire

Nancy, , France

Site Status

AP-HP Hopital Port Royal

Paris, , France

Site Status

CHU Hopital Gatien de Clocheville

Tours, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 26928567 (View on PubMed)

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.

Reference Type RESULT
PMID: 29193276 (View on PubMed)

Other Identifiers

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2009-012817-23

Identifier Type: REGISTRY

Identifier Source: secondary_id

MRU-09-02

Identifier Type: -

Identifier Source: org_study_id

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