High Flow Nasal Cannula in Comparison With Nasal Continuous Positive Airway Pressure in the Management of Respiratory Distress Syndrome

NCT02587832 | Completed

• 1 other identifier: 081110
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the primary outcome, failure of extubation defined by the need for re-intubation and mechanical ventilation within 5 days of initial extubation and secondary outcomes, morbidities and mortality after using of heated humidity high flow nasal cannula (HHHFNC) and Nasal Continuous Positive Airway Pressure (NCPAP) in the immediate post-extubation period for preterm infants between 24 and 28 weeks gestation with respiratory distress syndrome.

Conditions

Respiratory Distress Syndrome

Keywords

cpap; HHHFNC; RDS; ELBW

Outcome Measures

Primary Outcomes (1)

• the need for re-intubation

  The primary outcome measured was failed extubation defined by the need for re-intubation and mechanical ventilation within five days of initial extubation.

  5 DAYS

Secondary Outcomes (5)

• Duration of respiratory support using HHHFNC /NCPAP.

  through study completion, an average of 1 year.

• Incidence of nasal breakdown

  through study completion, an average of 24 weeks

• sepsis

  through study completion, an average of 1 year.

• intraventricular hemorrhage (IVH),

  through study completion, an average of 24 weeks

• retinopathy of prematurity (ROP)

  through study completion, an average of 24 weeks

Study Arms (2)

HHHFNC

ACTIVE COMPARATOR

Randomized to HHHFNC

Device: HHHFNC

NCPAP

ACTIVE COMPARATOR

Randomized to NCPAP

Device: NCPAP

Interventions

HHHFNC DEVICE

Tri-Anim Vaptherm the Precision Flow, which is a self contained unit that provides flow rates up to or 8 LPM (Infants) of blended oxygen that is heated and humidified

Also known as: VAPOTHERM

HHHFNC

NCPAP DEVICE

Bubble CPAP System.

NCPAP

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Preterm neonates with gestational age of 24 to 28 completed weeks.
• In the case of twins, both neonates were included in the same treatment arm.
• Success to wean with 24 hours to extubate.
• Parental written informed consent for participation in the study obtained on admission into the hospital or prior to delivery.

You may not qualify if:

• Evidence of severe birth asphyxia.
• Known genetic or chromosomal disorders.
• Infants delivered to mothers with ruptured membranes of more than three weeks duration.
• Potentially life-threatening conditions unrelated to prematurity.
• Participation in another clinical trial of any placebo, drug, biological, or device conducted under the provisions of a protocol.

Sponsors & Collaborators

• Sidra Medicine: lead
• Akron Children's Hospital: collaborator

Study Sites (1)

Akron Children's Hospital

Akron, Ohio, 44308, United States

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome; Microcephaly, Primary Autosomal Recessive, 6

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Mohammed Elkhwad, MD

  Akron Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 20, 2015
• First Posted: October 27, 2015
• Study Start: July 1, 2009
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: October 27, 2015

Record last verified: 2015-10

Locations

US (1)