Multicentre, randomised trial of preterm infants receiving caffeine and less invasive surfactant administration compared with caffeine and early continuous positive airway pressure (CaLI trial): study protocol.
Caffeine
/ therapeutic use
Continuous Positive Airway Pressure
Humans
Infant
Infant, Newborn
Infant, Premature
Multicenter Studies as Topic
Pulmonary Surfactants
/ therapeutic use
Randomized Controlled Trials as Topic
Respiratory Distress Syndrome, Newborn
/ therapy
Surface-Active Agents
/ therapeutic use
neonatal intensive & critical care
neonatology
respiratory medicine (see thoracic medicine)
Journal
BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874
Informations de publication
Date de publication:
22 01 2021
22 01 2021
Historique:
entrez:
23
1
2021
pubmed:
24
1
2021
medline:
15
5
2021
Statut:
epublish
Résumé
Respiratory distress syndrome (RDS) or surfactant deficiency occurs primarily in premature infants resulting in composite outcomes of death or bronchopulmonary dysplasia. Initial management strategies for preterm infants with RDS includes early initiation of continuous positive airway pressure (CPAP) and titration of fractional inspired oxygen (FiO CaLI is an unblinded multicentre, randomised controlled, trial of 180 preterm infants (24+0-29+6 weeks corrected GA). Criteria for intubation/treatment failure will follow guidelines for the management of RDS, including: (1) CPAP level of 6-8 cmH20 and FiO Chiesi Farmaceutici, S.p.A is the sponsor of CaLI. Ethical approval has been obtained. Results will be submitted for publication in peer reviewed journals. www.Clinicaltrials.gov: NCT04209946; Pre-results.
Identifiants
pubmed: 33483435
pii: bmjopen-2020-038343
doi: 10.1136/bmjopen-2020-038343
pmc: PMC7825253
doi:
Substances chimiques
Pulmonary Surfactants
0
Surface-Active Agents
0
Caffeine
3G6A5W338E
Banques de données
ClinicalTrials.gov
['NCT04209946']
Types de publication
Clinical Trial Protocol
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e038343Informations de copyright
© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: The principal investigator for the overall trial and each study site declare no financial or other competing interests.
Références
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