Respiratory Distress SyndromeNCT02587832
High Flow Nasal Cannula in Comparison With Nasal Continuous Positive Airway Pressure in the Management of Respiratory Distress Syndrome
A study testing HHHFNC and NCPAP in people with Respiratory Distress Syndrome, run by Sidra Medicine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Respiratory Distress Syndrome
- What is being tested?
- HHHFNC and NCPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Apr 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Respiratory Distress Syndrome
- Being tested
- HHHFNC, NCPAP
- Keywords
- cpap, HHHFNC, RDS, ELBW
- Medical subject headings
- Respiratory Distress Syndrome, Microcephaly, Primary Autosomal Recessive, 6
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HHHFNCDevice
Also called VAPOTHERM
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
NCPAPDevice
Bubble CPAP System.
| Study group | Role | What they receive |
|---|---|---|
| HHHFNC | Active comparator | Randomized to HHHFNC Receives: Device: HHHFNC |
| NCPAP | Active comparator | Randomized to NCPAP Receives: Device: NCPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 DAYS
Secondary outcomes (5)
Duration of respiratory support using HHHFNC /NCPAP.
Measured: through study completion, an average of 1 year.
Incidence of nasal breakdown
Measured: through study completion, an average of 24 weeks
sepsis
Measured: through study completion, an average of 1 year.
intraventricular hemorrhage (IVH),
Measured: through study completion, an average of 24 weeks
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.
Measured: through study completion, an average of 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2015 (estimated)
- Study startJul 2009
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidra Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Akron Children's Hospital
- Responsible party
- Principal investigator, Mohammed Elkhwad, Akron Children's Hospital
- Investigators
- Mohammed Elkhwad, MD, Principal investigator, Akron Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02587832
- Sponsor's protocol ID
- 081110
- Status last verified
- Oct 2015
- First submitted
- 20 Oct 2015
- Last updated
- 27 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02587832
- Acronym / sponsor ID
- 081110
- Conditions
- Respiratory Distress Syndrome
- Keywords
- cpap, HHHFNC, RDS, ELBW
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sidra MedicineUniversity, hospital or other
- Collaborators
- Akron Children's Hospital
- Study start
- Jul 2009
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 27 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HHHFNC | Active comparator | Device: HHHFNCRandomized to HHHFNC |
| NCPAP | Active comparator | Device: NCPAPRandomized to NCPAP |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HHHFNCAlso: VAPOTHERMTri-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 | Device | HHHFNC |
| NCPAPBubble CPAP System. | Device | NCPAP |
Primary outcome
the need for re-intubation
Time frame: 5 DAYS
The primary outcome measured was failed extubation defined by the need for re-intubation and mechanical ventilation within five days of initial extubation.
5 secondary outcomes
Duration of respiratory support using HHHFNC /NCPAP.
Time frame: through study completion, an average of 1 year.
Incidence of nasal breakdown
Time frame: through study completion, an average of 24 weeks
sepsis
Time frame: through study completion, an average of 1 year.
intraventricular hemorrhage (IVH),
Time frame: through study completion, an average of 24 weeks
retinopathy of prematurity (ROP)
Time frame: through study completion, an average of 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammed Elkhwad, MD principal investigator
Akron Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HHHFNC and NCPAP in people with Respiratory Distress Syndrome, run by Sidra Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the need for re-intubation (time frame: 5 DAYS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2015.