CURDYS: Exogenous Surfactant in Very Preterm Neonates in Prevention of Bronchopulmonary Dysplasia

Sponsor

Jean Michel Hascoet (Other)

Overall Status

Completed

CT.gov ID

NCT01039285

Collaborator

ARAIRLOR (Other), Chiesi Farmaceutici S.p.A. (Industry)

118

Enrollment

Locations

Arms

150

Actual Duration (Months)

9.1

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Infant, Premature, Diseases Respiratory Distress Syndrome, Newborn Bronchopulmonary Dysplasia	Drug: Curosurf Other: Air	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

118 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 1, 2009

Actual Primary Completion Date :

Sep 1, 2021

Actual Study Completion Date :

Jun 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

duration of assisted ventilation [days]
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 [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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Days to 16 Days

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	CHU Hopital Nord	Amiens	France	80054
2	CHU	Angers	France	49033
3	Centre Hospitalier	Arras	France	62000
4	CHU Hopital Clemenceau	Caen	France	14033
5	CHU hopital d'enfants	Dijon	France	21079
6	Centre Hospitalier	Lens	France	62037
7	CHU Hopital Jeanne de Flandre	Lille	France	59037
8	CHU Hopital de la Croix Rousse	Lyon	France	69004
9	APHM hopital de la conception	Marseille	France	13385
10	CHI Andre Gregoire	Montreuil	France	93105
11	Maternite Regionale Universitaire	Nancy	France	54042
12	AP-HP Hopital Port Royal	Paris	France	75179
13	CHU Hopital Gatien de Clocheville	Tours	France	37044