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
About this trial
This is an interventional treatment trial for Respiratory Distress Syndrome focused on measuring cpap, HHHFNC, RDS, ELBW
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.
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
NCT ID
NCT02587832
First Posted
October 20, 2015
Last Updated
October 25, 2015
Sponsor
Sidra Medical and Research Center
Collaborators
Akron Children's Hospital
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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