Less Invasive Beractant Administration in Preterm Infants

H

Hospital General Universitario Gregorio Marañon

Status

Completed

Conditions

Infant, Premature

Treatments

Procedure: LISA
Procedure: INSURE

Study type

Interventional

Funder types

Other

Identifiers

NCT02611284
2015-01

Details and patient eligibility

About

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).

Enrollment

60 patients

Sex

All

Ages

1 minute to 3 days old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Treatment Cohort (LISA)
Experimental group
Description:
All preterm infants born at < 32 WG between October 2013 and November 2014 who met inclusion criteria were managed by the new LISA technique.
Treatment:
Procedure: LISA
Historical Cohort (INSURE)
Other group
Description:
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.
Treatment:
Procedure: INSURE

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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