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Less Invasive Beractant Administration in Preterm Infants

Primary Purpose

Infant, Premature

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
LISA
INSURE
Sponsored by
Hospital General Universitario Gregorio Marañon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Infant, Premature focused on measuring Beractant, Feasibility Studies, Infant, Premature, Noninvasive Ventilation

Eligibility Criteria

1 Minute - 3 Days (Child)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Treatment Cohort (LISA)

    Historical Cohort (INSURE)

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    % patients >1 h of mechanical ventilation
    The percentage of patients that required more than 1 hour of mechanical ventilation during the first three days of age.

    Secondary Outcome Measures

    need for intermittent mechanical ventilation (iMV)
    need for iMV at any time and its duration
    second dose of surfactant
    the requirement of a second dose of surfactant
    bradycardia episodes
    the number of bradycardia episodes (<100 bpm) needing pressure inflations (PPI) during instillation
    attempts to catheterize
    the number of attempts to catheterize the trachea was recorded
    surfactant reflux cases
    the number of surfactant reflux cases

    Full Information

    First Posted
    November 16, 2015
    Last Updated
    August 23, 2021
    Sponsor
    Hospital General Universitario Gregorio Marañon
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02611284
    Brief Title
    Less Invasive Beractant Administration in Preterm Infants
    Official Title
    Less Invasive Beractant Administration in Preterm Infants: a Pilot Study.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2013 (undefined)
    Primary Completion Date
    November 2014 (Actual)
    Study Completion Date
    March 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital General Universitario Gregorio Marañon

    4. Oversight

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Infant, Premature
    Keywords
    Beractant, Feasibility Studies, Infant, Premature, Noninvasive Ventilation

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment Cohort (LISA)
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    Historical Cohort (INSURE)
    Arm Type
    Other
    Arm 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.
    Intervention Type
    Procedure
    Intervention Name(s)
    LISA
    Intervention Description
    All infants were supported with nCPAP while breathing spontaneously during instillation. A 5Frenchgamma sterilized multi-access catheter specifically designed to deliver surfactants for Neonates was placed 1-2 cm below the vocal cords by direct laryngoscopy without the use of a Magill forceps. Beractant was used as exogenous natural surfactant, (100mg/kg; 4ml/kg) and administered in two aliquots during 1-3 minutes. Positive pressure inflations were given by a mask and bag only if the infant was apneic or bradycardia develops despite the interruption of the procedure. The surfactant administration catheter was removed after surfactant instillation and nCPAP support was maintained. A second dose of surfactant was administered during the first 3 days of life if more than 40% of FiO2 was needed while on nCPAP with at least 6 cm H2O pressure.
    Intervention Type
    Procedure
    Intervention Name(s)
    INSURE
    Intervention Description
    The INSURE technique was performed using Beractant (4ml/kg) after endotracheal intubation. A multi-access catheter for Neonates/Pediatrics designed to deliver surfactants (KimVentTrach Care Technology ®, United Kingdom) was pre-connected to the endotracheal tube and used for surfactant administration without having to disconnect the ventilator. While surfactant was administered all infants were connected to pressure support ventilation modality (PSV) combined with volume guarantee (VG), Dräger ventilator). A tidal volume of 4ml/kg was initially adjusted. After surfactant administration, all infants were to be extubated, in accordance with our institutional extubation guidelines, if FiO2< 0.35; for a target Oxygen Saturation (SpO2) of >90%, and if a consistent respiratory effort was present. Extubation was supported with nCPAP in all patients.
    Primary Outcome Measure Information:
    Title
    % patients >1 h of mechanical ventilation
    Description
    The percentage of patients that required more than 1 hour of mechanical ventilation during the first three days of age.
    Time Frame
    through study completion, an average of 1 year
    Secondary Outcome Measure Information:
    Title
    need for intermittent mechanical ventilation (iMV)
    Description
    need for iMV at any time and its duration
    Time Frame
    through study completion, an average of 1 year
    Title
    second dose of surfactant
    Description
    the requirement of a second dose of surfactant
    Time Frame
    through study completion, an average of 1 year
    Title
    bradycardia episodes
    Description
    the number of bradycardia episodes (<100 bpm) needing pressure inflations (PPI) during instillation
    Time Frame
    through study completion, an average of 1 year
    Title
    attempts to catheterize
    Description
    the number of attempts to catheterize the trachea was recorded
    Time Frame
    through study completion, an average of 1 year
    Title
    surfactant reflux cases
    Description
    the number of surfactant reflux cases
    Time Frame
    through study completion, an average of 1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Minute
    Maximum Age & Unit of Time
    3 Days
    Accepts Healthy Volunteers
    No
    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.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    27074172
    Citation
    Ramos-Navarro C, Sanchez-Luna M, Zeballos-Sarrato S, Gonzalez-Pacheco N. Less invasive beractant administration in preterm infants: a pilot study. Clinics (Sao Paulo). 2016 Mar;71(3):128-34. doi: 10.6061/clinics/2016(03)02.
    Results Reference
    derived

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