Less Invasive Beractant Administration in Preterm Infants: a Pilot Study.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Infant, Premature
- Sponsor
- Hospital General Universitario Gregorio Marañon
- Enrollment
- 60
- Primary Endpoint
- % patients >1 h of mechanical ventilation
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The aim of this study is to assess the efficacy and feasibility of a new less invasive surfactant administration (LISA) technique with a specific designed cannula for surfactant administration using Beractant replacement in preterm infants <32 weeks of gestation and compare short and long term outcomes with the intubation, administration of surfactant and extubation method (INSURE).
This was a single-center, prospective, open-label, non-randomized, controlled study with an experimental cohort of 30 patients treated with LISA and a retrospective control group comprising the 30 most recently treated patients with INSURE. Beractant (4 ml/Kg) was administered as exogenous surfactant in both groups if patients on nasal continuous positive airway pressure (nCPAP) during the first three days of life were needed of more than 30% of fraction of inspired oxygen inspired oxygen fraction (FiO2).
Investigators
Manuel Sanchez Luna
Dr
Hospital General Universitario Gregorio Marañon
Eligibility Criteria
Inclusion Criteria
- •Preterm infants of less than 32 weeks of gestation (WG)breathing spontaneously on nCPAP during the first three days of life that met exogenous surfactant administration criteria (Table l) were eligible to enroll in the study
Exclusion Criteria
- •Infants who met intubation criteria (Table 1) at the moment of the surfactant administration were excluded in both groups.
Outcomes
Primary Outcomes
% patients >1 h of mechanical ventilation
Time Frame: through study completion, an average of 1 year
The percentage of patients that required more than 1 hour of mechanical ventilation during the first three days of age.
Secondary Outcomes
- need for intermittent mechanical ventilation (iMV)(through study completion, an average of 1 year)
- second dose of surfactant(through study completion, an average of 1 year)
- attempts to catheterize(through study completion, an average of 1 year)
- bradycardia episodes(through study completion, an average of 1 year)
- surfactant reflux cases(through study completion, an average of 1 year)