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

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
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
NCT ID
NCT02611284
First Posted
November 16, 2015
Last Updated
August 23, 2021
Sponsor
Hospital General Universitario Gregorio Marañon
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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Less Invasive Beractant Administration in Preterm Infants
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