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

Not Applicable

• Conditions: Respiratory Distress Syndrome
• Interventions: Procedure: ECALMIST; Procedure: InSure

• Registration Number: NCT01848262
• Lead Sponsor: University of Manitoba

Brief 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.

Detailed 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 Timeline

• Study First Submitted: 2013-05-02
• Study First Submitted QC: 2013-05-06
• Study First Posted: 2013-05-07
• Study Start: 2013-06
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-09
• Last Update Posted: 2014-02-11
• Primary Completion: 2015-06
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

All should apply:

• Newborn less than 32 weeks gestation at birth
• Postnatal age < 24 hrs of life
• Clinical diagnosis of RDS
• Spontaneously breathing on NCPAP
• Clinical decision to give surfactant.

Exclusion Criteria

• Lack of parental consent.
• Need for mechanical ventilation
• Major congenital malformation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ECALMIST	ECALMIST	ECALMIST will be used in preterm infants between 24 weeks to 31 weeks in the 1st day of life with RDS and spontaneously breathing with decision to give surfactant
InSurE	InSure	InSurE will be used in preterm infants between 24 weeks to 31 weeks in the 1st day of life with RDS and spontaneously breathing with decision to give surfactant

Primary Outcome Measures

Name	Time	Method
Incidence of early ventilation hours	3 days	The number of the newborn infants needed ventilation in the 1st 3 days of life

Secondary Outcome Measures

Name	Time	Method
Apnea	15 minutes	Pause or stop of breathing for more than 20 seconds or stop of breathing that associated with decrease oxygen saturation below 75% or decrease heart rate below 100 during ECALMIST or InSurE method of surfactant therapy
Desaturation	15 minutes	Decreased level of oxygen saturation measured by pulse oximeter to below 75% for more than 20 seconds during either ECALMIST or InSurE
Bradycardia	15 minutes	Decreased heart rate below 100 beat per minutes during ECALMIST or InSurE procedure
Total ventilation hours	hospital admition days	Number of total hours during which the newborn are ventilated during hospital admission (form delivery till discharge home)
Early ventilation hours	3 days	The mean of ventilation hours
Incidence of Chronic lung disease	1st 2 months of life	The incidence of Chronic lung disease (CLD) both definitions; the need for oxygen support at 28 days of postnatal life and at the 36 weeks of corrected postnatal age

Trial Locations

Locations (2)

St Boniface Hospital; 🇨🇦 Winnipeg, Manitoba, Canada

Health sciences Center; 🇨🇦 Winnipeg, Manitoba, Canada