Evaluating the efficacy of Seattle-PAP for the respiratory support of premature neonates: study protocol for a randomized controlled trial.
Trials
; 20(1): 63, 2019 Jan 18.
Article
in En
| MEDLINE
| ID: mdl-30658678
ABSTRACT
BACKGROUND:
At birth, the majority of neonates born at <30 weeks of gestation require respiratory support to facilitate transition and ensure adequate gas exchange. Although the optimal approach to the initial respiratory management is uncertain, the American Academy of Pediatrics endorses noninvasive respiratory support with nasal continuous positive airway pressure (nCPAP) for premature neonates with respiratory insufficiency. Despite evidence for its use, nCPAP failure, requiring intubation and mechanical ventilation, is common. Recently, investigators have described a novel method to deliver bubble nCPAP, termed Seattle-PAP. While preclinical and pilot studies are encouraging regarding the potential value of Seattle-PAP, a large trial is needed to compare Seattle-PAP directly with the current standard of care for bubble nCPAP (Fisher & Paykel CPAP or FP-CPAP). METHODS/DESIGN:
We designed a multicenter, non-blinded, randomized controlled trial that will enroll 230 premature infants (220/7 to 296/7 weeks of gestation). Infants will be randomized to receive Seattle-PAP or FP-CPAP. The primary outcome is respiratory failure requiring intubation and mechanical ventilation. Secondary outcomes include measures of short- and long-term respiratory morbidity and cost-effectiveness.DISCUSSION:
This trial will assess whether Seattle-PAP is more efficacious and cost-effective than FP-CPAP in real-world practice among premature neonates. TRIAL REGISTRATION ClinicalTrials.gov, NCT03085329 . Registered on 21 March 2017.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Respiration
/
Respiratory Distress Syndrome, Newborn
/
Infant, Premature
/
Continuous Positive Airway Pressure
/
Premature Birth
/
Lung
Type of study:
Clinical_trials
/
Etiology_studies
Limits:
Humans
/
Newborn
Country/Region as subject:
America do norte
Language:
En
Journal:
Trials
Journal subject:
MEDICINA
/
TERAPEUTICA
Year:
2019
Document type:
Article
Affiliation country: