Exogenous Surfactant in Very Preterm Neonates in Prevention of Bronchopulmonary Dysplasia

Bronchopulmonary Dysplasia Clinical Trial

— CURDYS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01039285
• Other study ID #: MRU-09-02
• Secondary ID: 2009-012817-23
• Status: Completed
• Phase: Phase 4
• Start date: December 2009
• Est. completion date: June 2022

Study information

• Verified date: August 2022
• Source: Maternite Regionale Universitaire
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: June 2022
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Days to 16 Days

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Curosurf
2.5 ml/kg instilled in the trachea

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

Locations

Country	Name	City	State
France	CHU Hopital Nord	Amiens
France	CHU	Angers
France	Centre Hospitalier	Arras
France	CHU Hopital Clemenceau	Caen
France	CHU hopital d'enfants	Dijon
France	Centre Hospitalier	Lens
France	CHU Hopital Jeanne de Flandre	Lille
France	CHU Hopital de la Croix Rousse	Lyon
France	APHM hopital de la conception	Marseille
France	CHI Andre Gregoire	Montreuil
France	Maternite Regionale Universitaire	Nancy
France	AP-HP Hopital Port Royal	Paris
France	CHU Hopital Gatien de Clocheville	Tours

Sponsors (3)

Lead Sponsor	Collaborator
Jean Michel Hascoet	ARAIRLOR, Chiesi Farmaceutici S.p.A.

Country where clinical trial is conducted

France, 

References & Publications (2)

Hascoët 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 ri — View Citation

Hascoët 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 Re — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	to reduce the incidence of BPD		36 weeks post conceptional age
Secondary	to improve the inflammatory status of the lung and to restore its capacities for healing and growth		one month
Secondary	to improve development in stature and weight, psychomotor development, and to reduce respiratory sequelae leading to re-hospitalisation		2 years of age
Secondary	to improve height development, psychomotor development and respiratory function		7 years of age