Respiratory Distress Syndrome in Premature Infants
Conditions
Keywords
Respiratory Distress syndrome, Complications of prematurity
Brief summary
The aim of this study is to investigate 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, adverse drug reactions, hematology and biochemistry values, the incidence of major neonatal morbidities including bronchopulmonary dysplasia (BPD) and mortality.
Detailed description
The study will be a multicentre, open-label, single escalating dose, per-cohort design.
Interventions
DRUGsynthetic surfactant (CHF5633)
CHF5633 100 mg/kg; CHF5633 200 mg/kg synthetic surfactant sterile suspension in 3.0 ml glass vials with a total concentration of 80 mg/ml for intratracheal administration. Single administration
Sponsors
Chiesi Farmaceutici S.p.A.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
27 Weeks to 34 Weeks
Healthy volunteers
No
Inclusion criteria
* Written informed consent obtained by parents/legal representative (according to local regulation) prior to any study-related procedures * Inborn and outborn, preterm neonates of either sex with a gestational age of 27 weeks up to 33 weeks+6 * Clinical and radiological findings typical of RDS * Age on admission to the study \< 24 hours from birth * Requirement of endotracheal intubation for surfactant administration * Fraction of inspired oxygen (FiO2) \> 0.35 to maintain SpO2 between 90-95 % * Documentation of normal cranial ultrasound scan
Exclusion criteria
* Use of surfactant prior to study entry and need for intratracheal administration of any other treatment (e.g. nitric oxide) * Known genetic or chromosomal disorders, major congenital anomalies (cardiac malformations, myelomeningocele etc) * Maternal drug abuse (heroin, methadone, methamphetamine, or cocaine) or significant alcohol consumption during pregnancy * Clinical chorioamnionitis (Appendix III) * Strong suspicion of congenital pneumonia/infection, sepsis * Evidence of severe birth asphyxia or a 5 minutes Apgar score less / equal 3 * Presence of air leaks prior to study entry * Neonatal seizures prior to study entry * Mothers with prolonged rupture of the membranes (\> 3 weeks duration) * Any condition that, in the opinion of the Investigator, would place the neonate at undue risk * 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 |
|---|---|
| Monitoring of adverse events following CHF5633 administration | For duration of hospital stay (expected average of 9 weeks) |
Secondary
| Measure | Time frame |
|---|---|
| CHF 5633 efficacy profile (oxygenation , ventilatory requirements and need for rescue surfactant treatment),systemic absorption and immunogenicity assesment | At min 30, at hrs 1, 3, 6, 12, 24, at days 2, 3, 7 and at days 10, 28, at 36 weeks pma post dosing for ventilatory requirements, at pre-dose and 3 hrs and 24 hrs post dosing for systemic absorption and at 8 wks after administration for immunogenicity |
Countries
United Kingdom
Outcome results
None listed