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
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University of Manitoba
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Incidence of early ventilation hours
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 24 Weeks to 31 Weeks (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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
Intervention: ECALMIST (Procedure)
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
Intervention: InSure (Procedure)
Outcomes
Primary Outcomes
Incidence of early ventilation hours
Time Frame: 3 days
The number of the newborn infants needed ventilation in the 1st 3 days of life
Secondary Outcomes
- Apnea(15 minutes)
- Desaturation(15 minutes)
- Bradycardia(15 minutes)
- Total ventilation hours(hospital admition days)
- Early ventilation hours(3 days)
- Incidence of Chronic lung disease(1st 2 months of life)
Investigators
Yahya Al Ethawi
Dr
University of Manitoba