Less Invasive Beractant Administration in Preterm Infants

NCT02611284 | Completed

• 1 other identifier: 2015-01
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Infant, Premature

Keywords

Beractant; Feasibility Studies; Infant, Premature; Noninvasive Ventilation

Outcome Measures

Primary Outcomes (1)

• % 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 Outcomes (5)

• need for intermittent mechanical ventilation (iMV)

  through study completion, an average of 1 year

• second dose of surfactant

  through study completion, an average of 1 year

• bradycardia episodes

  through study completion, an average of 1 year

• attempts to catheterize

  through study completion, an average of 1 year

• surfactant reflux cases

  through study completion, an average of 1 year

Study Arms (2)

Treatment Cohort (LISA)

EXPERIMENTAL

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

Historical Cohort (INSURE)

OTHER

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

Interventions

LISA PROCEDURE

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.

Treatment Cohort (LISA)

INSURE PROCEDURE

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.

Historical Cohort (INSURE)

Eligibility Criteria

• Age: 1 Minute - 3 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Infants who met intubation criteria (Table 1) at the moment of the surfactant administration were excluded in both groups.

Sponsors & Collaborators

• Hospital General Universitario Gregorio Marañon: lead

Related Publications (1)

• 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.

  PMID: 27074172 DERIVED

MeSH Terms

Conditions

Premature Birth

Interventions

Insure Cement

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: November 16, 2015
• First Posted: November 20, 2015
• Study Start: October 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: March 1, 2015
• Last Updated: August 27, 2021

Record last verified: 2021-08