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

Primary Purpose

Respiratory Distress Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HHHFNC
NCPAP
Sponsored by
Sidra Medical and Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Distress Syndrome focused on measuring cpap, HHHFNC, RDS, ELBW

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Akron Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

HHHFNC

NCPAP

Arm Description

Randomized to HHHFNC

Randomized to NCPAP

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Duration of respiratory support using HHHFNC /NCPAP.
Incidence of nasal breakdown
sepsis
intraventricular hemorrhage (IVH),
retinopathy of prematurity (ROP)
number of participants with sepsis will be compared between the two arms. Sepsis was defined as a positive culture result from blood with concomitant clinical symptoms. Positive cultures were defined as having positive growth from the cerebrospinal fluid, tracheal, blood, or urine specimens.

Full Information

First Posted
October 20, 2015
Last Updated
October 25, 2015
Sponsor
Sidra Medical and Research Center
Collaborators
Akron Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02587832
Brief Title
High Flow Nasal Cannula in Comparison With Nasal Continuous Positive Airway Pressure in the Management of Respiratory Distress Syndrome
Official Title
Randomized Control Trial: Heated Humidity High Flow Nasal Cannula in Comparison With Nasal Continuous Positive Airway Pressure in the Management of Respiratory Distress Syndrome in Extreme Low Birth Infants in Immediate Post Extubation Period
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sidra Medical and Research Center
Collaborators
Akron Children's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Inclusion criteria were: 1) Preterm neonates with gestational age of 24 to 28 completed weeks. 2) In the case of twins, both neonates were included in the same treatment arm. 3) Success to wean with 24 hours to extubate. 4) Parental written informed consent for participation in the study obtained on admission into the hospital or prior to delivery. Exclusion criteria were: 1) Evidence of severe birth asphyxia. 2) Known genetic or chromosomal disorders. 3) Infants delivered to mothers with ruptured membranes of more than three weeks duration. 4) Potentially life-threatening conditions unrelated to prematurity. 5) Participation in another clinical trial of any placebo, drug, biological, or device conducted under the provisions of a protocol. Randomization A computer-generated block-randomization sequence with random block sizes was used. Infants who were part of multiple births underwent individual randomization. Clinicians opened consecutively numbered, sealed, brown envelopes immediately before extubation to determine the study-group assignment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome
Keywords
cpap, HHHFNC, RDS, ELBW

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HHHFNC
Arm Type
Active Comparator
Arm Description
Randomized to HHHFNC
Arm Title
NCPAP
Arm Type
Active Comparator
Arm Description
Randomized to NCPAP
Intervention Type
Device
Intervention Name(s)
HHHFNC
Other Intervention Name(s)
VAPOTHERM
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
NCPAP
Intervention Description
Bubble CPAP System.
Primary Outcome Measure Information:
Title
the need for re-intubation
Description
The primary outcome measured was failed extubation defined by the need for re-intubation and mechanical ventilation within five days of initial extubation.
Time Frame
5 DAYS
Secondary Outcome Measure Information:
Title
Duration of respiratory support using HHHFNC /NCPAP.
Time Frame
through study completion, an average of 1 year.
Title
Incidence of nasal breakdown
Time Frame
through study completion, an average of 24 weeks
Title
sepsis
Time Frame
through study completion, an average of 1 year.
Title
intraventricular hemorrhage (IVH),
Time Frame
through study completion, an average of 24 weeks
Title
retinopathy of prematurity (ROP)
Description
number of participants with sepsis will be compared between the two arms. Sepsis was defined as a positive culture result from blood with concomitant clinical symptoms. Positive cultures were defined as having positive growth from the cerebrospinal fluid, tracheal, blood, or urine specimens.
Time Frame
through study completion, an average of 24 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammed Elkhwad, MD
Organizational Affiliation
Akron Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Akron Children's Hospital
City
Akron
State/Province
Ohio
ZIP/Postal Code
44308
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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