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

University of Manitoba

Status: Unknown

Conditions: Respiratory Distress Syndrome

Treatments: Procedure: InSure; Procedure: ECALMIST

Study type: Interventional

Funder types: Other

Identifiers

NCT01848262

B2013:054

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 24 to 31 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

ECALMIST

Active Comparator group

Description:

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

Treatment:

Procedure: ECALMIST

InSurE

Experimental group

Description:

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

Treatment:

Procedure: InSure