The role of recombinant human CC10 in the prevention of chronic pulmonary insufficiency of prematurity.
Anti-Inflammatory Agents
/ therapeutic use
Chronic Disease
Double-Blind Method
Female
Genetic Predisposition to Disease
Gestational Age
Humans
Infant, Newborn
Infant, Premature
Infant, Premature, Diseases
Lung
/ drug effects
Lung Diseases
/ drug therapy
Male
Patient Readmission
Patient Safety
Pulmonary Surfactants
/ administration & dosage
Recombinant Proteins
/ therapeutic use
Respiration
Respiratory Distress Syndrome, Newborn
/ drug therapy
Risk Factors
Treatment Outcome
Uteroglobin
/ therapeutic use
Journal
Pediatric research
ISSN: 1530-0447
Titre abrégé: Pediatr Res
Pays: United States
ID NLM: 0100714
Informations de publication
Date de publication:
08 2019
08 2019
Historique:
received:
05
12
2018
accepted:
21
04
2019
revised:
16
02
2019
pubmed:
16
5
2019
medline:
11
7
2020
entrez:
16
5
2019
Statut:
ppublish
Résumé
Preterm neonates can develop chronic pulmonary insufficiency of prematurity (CPIP) later in infancy. Recombinant human CC10 protein (rhCC10) is an anti-inflammatory agent that could potentially prevent CPIP. The safety and efficacy of a single intratracheal dose of rhCC10 in reducing CPIP at 12 months corrected gestational age (CGA) was evaluated in a Phase II double-blind, randomized, placebo-controlled, multisite clinical trial. Eighty-eight neonates were randomized: 22 to placebo and 22 to 1.5 mg/kg rhCC10 in the first cohort and 21 to placebo and 23 to 5 mg/kg rhCC10 in the second cohort. Neonates were followed to 12 months CGA. With CPIP defined as signs/symptoms, medical visits, hospital readmissions, and use of medications for respiratory complications at 12 months CGA, no significant differences were observed between rhCC10 or placebo groups. Only 5% of neonates had no evidence of CPIP at 12 months CGA. A single dose of rhCC10 was not effective in reducing CPIP at 12 CGA. Since most neonates had evidence of CPIP using these exploratory endpoints, it is essential to develop more robust outcome measures for clinical trials of respiratory medications in high-risk premature neonates.
Sections du résumé
BACKGROUND
Preterm neonates can develop chronic pulmonary insufficiency of prematurity (CPIP) later in infancy. Recombinant human CC10 protein (rhCC10) is an anti-inflammatory agent that could potentially prevent CPIP.
METHODS
The safety and efficacy of a single intratracheal dose of rhCC10 in reducing CPIP at 12 months corrected gestational age (CGA) was evaluated in a Phase II double-blind, randomized, placebo-controlled, multisite clinical trial. Eighty-eight neonates were randomized: 22 to placebo and 22 to 1.5 mg/kg rhCC10 in the first cohort and 21 to placebo and 23 to 5 mg/kg rhCC10 in the second cohort. Neonates were followed to 12 months CGA.
RESULTS
With CPIP defined as signs/symptoms, medical visits, hospital readmissions, and use of medications for respiratory complications at 12 months CGA, no significant differences were observed between rhCC10 or placebo groups. Only 5% of neonates had no evidence of CPIP at 12 months CGA.
CONCLUSIONS
A single dose of rhCC10 was not effective in reducing CPIP at 12 CGA. Since most neonates had evidence of CPIP using these exploratory endpoints, it is essential to develop more robust outcome measures for clinical trials of respiratory medications in high-risk premature neonates.
Identifiants
pubmed: 31086287
doi: 10.1038/s41390-019-0419-3
pii: 10.1038/s41390-019-0419-3
pmc: PMC9487981
mid: NIHMS1528574
doi:
Substances chimiques
Anti-Inflammatory Agents
0
Pulmonary Surfactants
0
Recombinant Proteins
0
SCGB1A1 protein, human
0
Uteroglobin
9060-09-7
Types de publication
Clinical Trial, Phase II
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, U.S. Gov't, P.H.S.
Langues
eng
Sous-ensembles de citation
IM
Pagination
254-260Subventions
Organisme : FDA HHS
ID : R01 FD003899
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR001064
Pays : United States
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