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

Respiratory Distress Syndrome Clinical Trial

— ECALMIST  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01848262
• Other study ID #: B2013:054
• Status: Recruiting
• Phase: N/A
• First received: May 2, 2013
• Last updated: February 9, 2014
• Start date: June 2013
• Est. completion date: June 2015

Study information

• Verified date: February 2014
• Source: University of Manitoba
• Contact: Yahya Ethawi, MD
• Phone: 2049634721
• Email: yalethawi[@]hsc.mb.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 24 Weeks to 31 Weeks

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Health sciences Center	Winnipeg	Manitoba
Canada	St Boniface Hospital	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hospital stay	The number of days that newborn spent in the hospital after delivery	1st three months of life	No
Primary	Incidence of early ventilation hours	The number of the newborn infants needed ventilation in the 1st 3 days of life	3 days	No
Secondary	Apnea	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	15 minutes	Yes
Secondary	Bradycardia	Decreased heart rate below 100 beat per minutes during ECALMIST or InSurE procedure	15 minutes	Yes
Secondary	Desaturation	Decreased level of oxygen saturation measured by pulse oximeter to below 75% for more than 20 seconds during either ECALMIST or InSurE	15 minutes	Yes
Secondary	Total ventilation hours	Number of total hours during which the newborn are ventilated during hospital admission (form delivery till discharge home)	hospital admition days	No
Secondary	Incidence of Chronic lung disease	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	1st 2 months of life	No
Secondary	Early ventilation hours	The mean of ventilation hours	3 days	No