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

NCT01848262 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2014-02-11

No results posted yet for this study

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.

Conditions

  • Respiratory Distress Syndrome

Interventions

PROCEDURE

ECALMIST

Surfactant administration via 17 (5 French) gauge, 133 mm length vascular catheter. 5 ml/kg will be drawn up in a 5 or 10 ml syringe. The vascular catheter will be inserted through the vocal cords under direct vision using a standard laryngoscope with the appropriate blade for gestational age. The procedure will be done without removing the NCPAP. A bolus of surfactant of 0.25-0.5 ml will be administered, after observing the surfactant moving up and down as indication of accurate intubation of the trachea. The surfactant will be slowly injected by small pulses of 0.25-0.5 ml over 20-30 seconds, each bolus with 10 seconds apart. At the end of the procedure, the operator will flush the catheter with 0.5 ml of air before removing the catheter.

PROCEDURE

InSure

Patients who will receive surfactant via this technique will have their NCPAP removed and then they will be orally intubated with a standard endotracheal tube (ETT) using standard endotracheal intubation procedures using appropriate size ETT according to the birth weight. Bovine surfactant will be administered through the ETT using the same technique described above for arm 1. Manual lung inflation using a Jackson -Rees anesthesia bag at 20/5-cm H2O pressure will be performed during the surfactant instillation after which the patient will be extubated promptly as per the discretion of the neonatal team. Immediately following extubation, nCPAP support will be recommenced. No premedication, such as sedation or atropine, will be used during either procedure.

Sponsors & Collaborators

  • University of Manitoba

    lead OTHER

Principal Investigators

  • Yahya Ethawi, MD · University of Manitoba

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
24 Weeks
Max Age
31 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01848262 on ClinicalTrials.gov