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Completed

NCT Number: NCT01039285

Exogenous Surfactant in Very Preterm Neonates 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.

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Key information

Conditions

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

Age range

12 day–16 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHU Hopital Nord, Amiens, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Curosurf

Drug

2.5 ml/kg instilled in the trachea

Air

Other

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

Primary outcomes

  1. duration of assisted ventilation

    Time frame: 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 outcomes

  1. to reduce the incidence of BPD

    Time frame: 36 weeks post conceptional age

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

    Time frame: one month

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

    Time frame: 2 years of age

  4. to improve height development, psychomotor development and respiratory function

    Time frame: 7 years of age

Sponsors and collaborators

Lead sponsor

Jean Michel Hascoet

Other

Collaborators

  • ARAIRLOR
  • Chiesi Farmaceutici S.p.A.

Registry information

Official study title

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

Acronym: CURDYS

Important dates

Study start
2009
Primary completion
2021
Study completion
2022
First posted
Dec 24, 2009
Registry last updated
Aug 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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