Less Invasive Beractant Administration in Preterm Infants

Study Overview
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Brief Summary
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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).

Official Title
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Less Invasive Beractant Administration in Preterm Infants: a Pilot Study.

Conditions
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Infant, Premature

Intervention / Treatment
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* Procedure: LISA
* Procedure: INSURE


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Minute
Maximum Age: 3 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Cohort (LISA)<br>All preterm infants born at < 32 WG between October 2013 and November 2014 who met inclusion criteria were managed by the new LISA technique. | Procedure: LISA<br>* 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.<br>|
| Other: Historical Cohort (INSURE)<br>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. | Procedure: INSURE<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % 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. | through study completion, an average of 1 year | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Beractant, Feasibility Studies, Infant, Premature, Noninvasive Ventilation