A first-in-human clinical study of a new SP-B and SP-C enriched synthetic surfactant (CHF5633) in preterm babies with respiratory distress syndrome.

ABSTRACT:

Objective

CHF5633 (Chiesi Farmaceutici S.p.A., Parma, Italy) is the first fully synthetic surfactant enriched by peptide analogues of two human surfactant proteins. We planned to assess safety and tolerability of CHF5633 and explore preliminary efficacy.

Design

Multicentre cohort study.

Patients

Forty infants from 27⁺⁰ to 33⁺⁶ weeks gestation with respiratory distress syndrome requiring fraction of inspired oxygen (FiO₂) ≥0.35 were treated with a single dose of CHF5633 within 48 hours after birth. The first 20 received 100 mg/kg and the second 20 received 200 mg/kg.

Outcome measures

Adverse events (AEs) and adverse drug reactions (ADRs) were monitored with complications of prematurity considered AEs if occurring after dos

SUBMITTER: Sweet DG 

PROVIDER: S-EPMC5739829 | biostudies-literature | 2017 Nov

REPOSITORIES: biostudies-literature