preterm neonates with Respiratory Distress Syndrome (RDS) MedDRA version: 16.0 Level: LLT Classification code 10038690 Term: Respiratory distress syndrome (neonatal) System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 16.0 Level: PT Classification code 10028974 Term: Neonatal respiratory distress syndrome System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Code: CHF5633
Pharmaceutical Form: Endotracheopulmonary instillation, suspension
INN or Proposed INN: colfosceril palmitate
Current Sponsor code: CHF 5300.00
Other descriptive name: 1.2 DIPALM
acetate salt
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 0.16-
Sponsors
Chiesi Farmaceutici S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. 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. 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): None;Timepoint(s) of evaluation of this end point: None | — |
Countries
Czech Republic, Germany, United Kingdom
Contacts
Public ContactGuido Varoli
Chiesi Farmaceutici S.p.A.
Outcome results
None listed