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ECALMIST Versus InSurE in Preterm Infant < 32 Weeks,Multicenter, Multinational RCT — ECALMIST  

Respiratory Distress Syndrome Clinical Trial

Official title:
ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant Therapy) Versus InSurE (Intubate, Surfactant, Extubate) in Preterm Infants With Respiratory Distress Syndrome (RDS): Prospective Randomised Control Clinical Trial

Clinical Trial Summary

Minimally invasive surfactant therapy via a small vascular catheter - ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant Therapy) versus InSurE (Intubate, Surfactant Extubate) in preterm infants with Respiratory Distress Syndrome (RDS): A prospective randomized clinical trial.

Clinical Trial Description

After meeting all the inclusion criteria, eligible infants will be randomized to receive surfactant either through the ECALMIST or the InSurE methods. The attending neonatologist or neonatal team will have full discretion to decide when to intubate and when to extubate or wean the infant off the ventilator or NCPAP.

General guidelines for reintubation include persistent pH<7.20, PaCO2 > 65 mmHg, very frequent apnea (>2-3/hour of apneic or bradycardic spells not responsive to corrective therapy), frequent desaturations >3/hour not responding to increase in FiO2 or increase in FiO2 to 100%), or apneas requiring prolonged PPV. For the purpose of the study a successful outcome for the primary objective will have occurred if the infant has not been reintubated and ventilated during the initial 3 days of life. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01848262
Study type Interventional
Source University of Manitoba
Contact Yahya Ethawi, MD
Phone 2049634721
Email yalethawi@hsc.mb.ca
Status Recruiting
Phase N/A
Start date June 2013
Completion date June 2015
View Details
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