NCT01651637

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2012

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2012

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 27, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2015

Completed
Last Updated

July 31, 2020

Status Verified

July 1, 2020

Enrollment Period

2.3 years

First QC Date

April 20, 2012

Last Update Submit

July 30, 2020

Conditions

Respiratory Distress Syndrome in Premature Infants

Keywords

Respiratory Distress syndromeComplications of prematurity

Outcome Measures

Primary Outcomes (1)

  • Monitoring of adverse events following CHF5633 administration

    For duration of hospital stay (expected average of 9 weeks)

Secondary Outcomes (1)

  • 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

Study Arms (1)

Synthetic Surfactant

EXPERIMENTAL

Cohort Design

Drug: synthetic surfactant (CHF5633)

Interventions

synthetic surfactant (CHF5633)DRUG

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

Synthetic Surfactant

Eligibility Criteria

Age27 Weeks - 34 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liverpool Women's Hospital Neonatal Unit Liverpool Women's Hospital

Liverpool, United Kingdom

Location

Related Publications (1)

  • Sweet DG, Turner MA, Stranak Z, Plavka R, Clarke P, Stenson BJ, Singer D, Goelz R, Fabbri L, Varoli G, Piccinno A, Santoro D, Speer CP. 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. Arch Dis Child Fetal Neonatal Ed. 2017 Nov;102(6):F497-F503. doi: 10.1136/archdischild-2017-312722. Epub 2017 May 2.

    PMID: 28465315RESULT

Related Links

MeSH Terms

Conditions

Respiratory Distress Syndrome In Premature InfantsRespiratory Distress Syndrome

Interventions

Surface-Active AgentsCHF5633

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Intervention Hierarchy (Ancestors)

Specialty Uses of ChemicalsChemical Actions and Uses

Study Officials

  • Christian Speer, MD

    Universitäts-Kinderklinik Würzburg (Germany)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2012

First Posted

July 27, 2012

Study Start

October 1, 2012

Primary Completion

January 23, 2015

Study Completion

January 23, 2015

Last Updated

July 31, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)