Exogenous Surfactant in Very Preterm Neonates in Prevention of Bronchopulmonary Dysplasia

NCT01039285 | Completed Phase 4 DMC

• 2 other identifiers: MRU-09-022009-012817-23
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 13

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.

Conditions

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

Keywords

Very premature infant; Surfactant; Respiratory Distress; Bronchopulmonary Dysplasia

Outcome Measures

Primary Outcomes (1)

• 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.

  days

Secondary Outcomes (4)

• to reduce the incidence of BPD

  36 weeks post conceptional age

• to improve the inflammatory status of the lung and to restore its capacities for healing and growth

  one month

• to improve development in stature and weight, psychomotor development, and to reduce respiratory sequelae leading to re-hospitalisation

  2 years of age

• to improve height development, psychomotor development and respiratory function

  7 years of age

Study Arms (2)

Surfactant instillation

EXPERIMENTAL

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

Drug: Curosurf

Placebo instillation

PLACEBO COMPARATOR

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

Other: Air

Interventions

Curosurf DRUG

2.5 ml/kg instilled in the trachea

Surfactant instillation

Air OTHER

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

Placebo instillation

Eligibility Criteria

• Age: 12 Days - 16 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jean Michel Hascoet: lead
• ARAIRLOR: collaborator
• Chiesi Farmaceutici S.p.A.: collaborator

Study Sites (13)

CHU Hopital Nord

Amiens, 80054, France

Location

CHU

Angers, 49033, France

Location

Centre Hospitalier

Arras, 62000, France

Location

CHU Hopital Clemenceau

Caen, 14033, France

Location

CHU hopital d'enfants

Dijon, 21079, France

Location

Centre Hospitalier

Lens, 62037, France

Location

CHU Hopital Jeanne de Flandre

Lille, 59037, France

Location

CHU Hopital de la Croix Rousse

Lyon, 69004, France

Location

APHM hopital de la conception

Marseille, 13385, France

Location

CHI Andre Gregoire

Montreuil, 93105, France

Location

Maternite Regionale Universitaire

Nancy, 54042, France

Location

AP-HP Hopital Port Royal

Paris, 75179, France

Location

CHU Hopital Gatien de Clocheville

Tours, 37044, France

Location

Related Publications (2)

• 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.

  PMID: 26928567 RESULT

• 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.

  PMID: 29193276 RESULT

MeSH Terms

Conditions

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

Interventions

poractant alfa; Air

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Respiratory Distress Syndrome; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Ventilator-Induced Lung Injury; Lung Injury; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment and Public Health

Study Officials

• Jean-Michel HASCOET, MD

  Maternite Regionale Universitaire NANCY

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 23, 2009
• First Posted: December 24, 2009
• Study Start: December 1, 2009
• Primary Completion: September 1, 2021
• Study Completion: June 1, 2022
• Last Updated: August 24, 2022

Record last verified: 2022-08

Locations

FR (13)