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

Exogenous Surfactant in Very Preterm Neonates Presenting With Severe Respiratory Distress in Prevention of Bronchopulmonary Dysplasia

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.

Study Overview

• Status: Completed
• Conditions: Infant, Premature, Diseases; Respiratory Distress Syndrome, Newborn; Bronchopulmonary Dysplasia
• Intervention / Treatment: Drug: Curosurf; Other: Air

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Amiens, France, 80054
    • CHU Hôpital Nord
  • Angers, France, 49033
    • CHU
  • Arras, France, 62000
    • Centre Hospitalier
  • Caen, France, 14033
    • CHU Hôpital Clemenceau
  • Dijon, France, 21079
    • CHU Hôpital d'Enfants
  • Lens, France, 62037
    • Centre Hospitalier
  • Lille, France, 59037
    • CHU Hopital Jeanne de Flandre
  • Lyon, France, 69004
    • CHU Hopital de la Croix Rousse
  • Marseille, France, 13385
    • APHM Hôpital de la Conception
  • Montreuil, France, 93105
    • CHI André Grégoire
  • Nancy, France, 54042
    • Maternite Regionale Universitaire
  • Paris, France, 75179
    • AP-HP Hopital Port Royal
  • Tours, France, 37044
    • CHU Hopital Gatien de Clocheville

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 week to 2 weeks (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Jean Michel Hascoet
• Collaborators: Chiesi Farmaceutici S.p.A.; ARAIRLOR
• Investigators: Study Director: Jean-Michel HASCOET, MD, Maternite Regionale Universitaire NANCY

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2009
• Primary Completion (Actual): September 1, 2021
• Study Completion (Actual): June 1, 2022

Study Registration Dates

• First Submitted: December 23, 2009
• First Submitted That Met QC Criteria: December 23, 2009
• First Posted (Estimate): December 24, 2009

Study Record Updates

• Last Update Posted (Actual): August 24, 2022
• Last Update Submitted That Met QC Criteria: August 23, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Surfactant; Bronchopulmonary Dysplasia; Respiratory Distress; Very premature infant
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Lung Injury; Ventilator-Induced Lung Injury; Infant, Premature, Diseases; Hyperplasia; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Bronchopulmonary Dysplasia; Respiratory System Agents; Pulmonary Surfactants; Poractant alfa
• Other Study ID Numbers: MRU-09-02; 2009-012817-23 (Registry Identifier: EUDRACT)