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

NCT ID: NCT01848262

Last Updated: 2014-02-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2015-06-30

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.

Conditions

Respiratory Distress Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

ECALMIST

Intervention Type: PROCEDURE

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.

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

Group Type: EXPERIMENTAL

InSure

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

CPAP and Minimal Invasive Surfactant Therapy; Intubate surfcatant extubate

Eligibility Criteria

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

• Minimum Eligible Age: 24 Weeks
• Maximum Eligible Age: 31 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Manitoba

OTHER

Sponsor Role: lead

Responsible Party

Yahya Al Ethawi

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yahya Ethawi, MD

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Locations

Health sciences Center

Winnipeg, Manitoba, Canada

Site Status: RECRUITING

St Boniface Hospital

Winnipeg, Manitoba, Canada

Site Status: NOT_YET_RECRUITING

Countries

Canada

Central Contacts

Yahya Ethawi, MD

Role: CONTACT

yalethawi@hsc.mb.ca

2049634721

Abrar Hussain, MD

Role: CONTACT

ahussain3@hsc.mb.ca

2047719301

Facility Contacts

Yahya Ethawi, MD

Role: primary

yalethawi@hsc.mb.ca

12049634721

Mohamed Tagin, MD

Role: backup

mtagin@hsc.mb.ca

12044304250

Yahya Ethawi, MD

Role: primary

yalethawi@hsc.mb.ca

10249634721

Mohamed Tagin, MD

Role: backup

mtagin@hsc.m.ca

12044304250

Other Identifiers

B2013:054

Identifier Type: -

Identifier Source: org_study_id