Study On Safety And Efficacy Of A New Drug CHF 5633 To Treat Respiratory Failure In Premature Babies

Phase 1

• Conditions: Preterm neonates with Respiratory Distress Syndrome (RDS); MedDRA version: 14.1Level: LLTClassification code 10038690Term: Respiratory distress syndrome (neonatal)System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 14.1Level: PTClassification code 10028974Term: Neonatal respiratory distress syndromeSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]

• Registration Number: EUCTR2011-001331-22-GB
• Lead Sponsor: Chiesi Farmaceutici S.p.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-04-02
• Study Completion: 2015-01-23
• Last Update Posted: 13 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1.Written informed consent obtained by parents/legal representative (according to local regulation) prior to any study-related procedures
2.Inborn and outborn, preterm neonates of either sex with a gestational age of 27 weeks up to 33 weeks+6
3.Clinical and radiological findings typical of RDS
4.Test treatment administration within 48 hours from birth
5.Requirement for endotracheal surfactant administration
6.Fraction of inspired oxygen (FiO2) =0.35 to maintain SpO2 between 90–95 %
7.Documentation of normal cranial ultrasound scan.

Are the trial subjects under 18? yes
Number of subjects for this age range: 40
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Use of surfactant prior to study entry and need for intratracheal administration of any other treatment (e.g. nitric oxide)
2.Known genetic or chromosomal disorders, major congenital anomalies (cardiac malformations, myelomeningocele etc)
3.Maternal drug abuse (heroin, methadone, methamphetamine, or cocaine) or significant alcohol consumption during pregnancy
4.Strong suspicion of congenital pneumonia/infection, sepsis
5.Evidence of severe birth asphyxia or a 5 minutes Apgar score =3
6.Presence of air leaks prior to study entry
7.Neonatal seizures prior to study entry
8.Mothers with prolonged rupture of the membranes (> 3 weeks duration)
9.Any condition that, in the opinion of the Investigator, would place the neonate at undue risk
10.Participation in another clinical trial of any placebo, drug or biological substance conducted under the provisions of a protocol.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary aim of this study is to evaluate the safety and tolerability of intratracheal administration of two different single doses of CHF 5633 in preterm neonates with RDS, in terms of adverse events (AEs) and adverse drug reactions (ADRs), haematology and biochemistry values and incidence of major neonatal morbidities and mortality. ;Secondary Objective: To explore the effect of the drug on oxygenation and ventilatory requirements and need for rescue surfactant treatment.<br>To evaluate the extent of systemic exposure to SP-B analogue (CHF 5736.03) and SP-C analogue (CHF 4902.03) contained in CHF 5633.<br>To assess immunogenicity through the measurement of antibodies to SP-B analogue (CHF 5736.03) and SP-C analogue (CHF 4902.03) contained in CHF 5633.;Primary end point(s): Due to the nature of this study design an end point is not defined; please refer to the study objectives (E.2);Timepoint(s) of evaluation of this end point: None

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): None;Timepoint(s) of evaluation of this end point: None