Less Invasive Beractant Administration in Preterm Infants

Infant, Premature Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02611284
• Other study ID #: 2015-01
• Status: Completed
• Phase: N/A
• Start date: October 2013
• Est. completion date: March 2015

Study information

• Verified date: August 2021
• Source: Hospital General Universitario Gregorio Marañon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Days

Eligibility

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.

Related Conditions & MeSH terms

• Infant, Premature
• Premature Birth

Intervention

Procedure:
• LISA
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.
• INSURE
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General Universitario Gregorio Marañon

Outcome

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