Less Invasive Beractant Administration in Preterm Infants

Not Applicable

Completed

• Conditions: Infant, Premature
• Interventions: Procedure: LISA; Procedure: INSURE

• Registration Number: NCT02611284
• Lead Sponsor: Hospital General Universitario Gregorio Marañon

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Primary Completion: 2014-11
• Study Completion: 2015-03
• Study First Submitted: 2015-11-16
• Study First Submitted QC: 2015-11-18
• Study First Posted: 2015-11-20
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-23
• Last Update Posted: 2021-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Cohort (LISA)	LISA	All preterm infants born at \< 32 WG between October 2013 and November 2014 who met inclusion criteria were managed by the new LISA technique.
Historical Cohort (INSURE)	INSURE	The control group was collected from the period immediately before the study's initiation (from Jun 2012 to September 2013). This cohort was comprised of preterm infants of less than 32 WG who met the inclusion criteria.

Primary Outcome Measures

Name	Time	Method
% patients >1 h of mechanical ventilation	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 Outcome Measures

Name	Time	Method
need for intermittent mechanical ventilation (iMV)	through study completion, an average of 1 year	need for iMV at any time and its duration
second dose of surfactant	through study completion, an average of 1 year	the requirement of a second dose of surfactant
attempts to catheterize	through study completion, an average of 1 year	the number of attempts to catheterize the trachea was recorded
bradycardia episodes	through study completion, an average of 1 year	the number of bradycardia episodes (\<100 bpm) needing pressure inflations (PPI) during instillation
surfactant reflux cases	through study completion, an average of 1 year	the number of surfactant reflux cases