First In Human Study on Synthetic Surfactant CHF 5633 in Respiratory Distress Syndrome

Chiesi

Status and phase

Completed

Phase 1

Conditions

Respiratory Distress Syndrome in Premature Infants

Treatments

Drug: synthetic surfactant (CHF5633)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01651637

CCD-1011-PR-0059

Details and patient eligibility

About

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.

Full description

The study will be a multicentre, open-label, single escalating dose, per-cohort design.

Enrollment

40 patients

Sex

All

Ages

27 to 34 weeks old

Volunteers

No Healthy Volunteers

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