Apnea of PrematurityNCT03292562
A Comparison of Methods of Discontinuing Nasal CPAP in Premature Infants <30 Weeks Gestation
A study testing Discontinue NCPAP after weaning pressures and Discontinue NCPAP without weaning pressures in people with Apnea of Prematurity and Respiratory Distress Syndrome, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to determine if among infants <30 weeks gestational age on nasal continuous positive airway pressure (NCPAP), whether discontinuing CPAP after gradual reduction in continuous positive airway pressure (CPAP) pressure leads to successful weaning off CPAP when compared to discontinuing CPAP… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Apnea of Prematurity, Respiratory Distress Syndrome
- What is being tested?
- Discontinue NCPAP after weaning pressures and Discontinue NCPAP without weaning pressures
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2017to 31 Mar 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- All infants < 30 weeks by dates, on NCPAP therapy, on caffeine 10mg/kg daily
- Meet CPAP stability criteria for ≥ 12hours (CPAP 6 cm water (H2O), FiO2 </=0.25 and stable (to maintain sats 85-95%), Respiratory rate consistently less than 60, Mild to no subcostal/intercostal retractions, No Apnea or bradycardia event that requires bag mask ventilation, Less than 3 apnea/brady/desat episodes in any 1 hour period for previous 6 hours, Tolerated time off CPAP during routine CPAP care (~15 min)
Who cannot join
- Major congenital anomalies including congenital heart disease
- Anomalies that prevent discontinuation of NCPAP
- Undergoing current evaluation for and/or treatment of sepsis
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: A Comparison of Methods of Discontinuing Nasal CPAP in Premature Infants <30 Weeks Gestation - a Feasibility Study
The purpose of this study is to determine if among infants <30 weeks gestational age on nasal continuous positive airway pressure (NCPAP), whether discontinuing CPAP after gradual reduction in continuous positive airway pressure (CPAP) pressure leads to successful weaning off CPAP when compared to discontinuing CPAP without weaning pressure.
- Being tested
- Discontinue NCPAP after weaning pressures, Discontinue NCPAP without weaning pressures
- Medical subject headings
- Apnea, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Discontinue NCPAP after weaning pressuresDevice
After randomization, CPAP pressure will be weaned by 1 every 24hours as long as the subjects continue to meet stability criteria after each wean, until CPAP of 4. If after decrease in CPAP pressure, the subject meets CPAP failure criteria pressure will be increased back to the previous level and after stabilization for 24 hours weaning process will be started again. Once the subject meets stability criteria on CPAP of 4, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1 Liter flow, 30% FiO2).
Discontinue NCPAP without weaning pressuresDevice
After randomization, once the subject meets stability criteria, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1 Liter flow, 30% FiO2).
| Study group | Role | What they receive |
|---|---|---|
| Discontinue NCPAP after weaning pressures | Active comparator | After randomization, CPAP pressure will be weaned by 1 every 24hours as long as the subjects continue to meet stability criteria after each wean, until CPAP of 4. If after decrease in CPAP pressure, the subject meets CPAP failure criteria pressure will be increased back to the previous level and after stabilization for 24 hours weaning process will be started again. Once the subject meets stability criteria on CPAP of 4, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1 Liter flow, 30% FiO2). Receives: Device: Discontinue NCPAP after weaning pressures |
| Discontinue NCPAP without weaning pressures | Active comparator | After randomization, once the subject meets stability criteria, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1 Liter flow, 30% FiO2). Receives: Device: Discontinue NCPAP without weaning pressures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Days on NCPAP or Mechanical Ventilation
Subjects might go on and off NCPAP or mechanical ventilation throughout the 28 days after randomization, and the total number of days will be reported.
Measured: from randomization until 28 days post-randomization
Secondary outcomes (7)
Duration of Endotracheal Ventilation
Subjects might go on and off endotracheal ventilation throughout the 28 days after randomization, and the total number of days will be reported.
Measured: from randomization until 28 days post-randomization
Number of Participants Who Failed to Wean Off NCPAP
Measured: from randomization until discharge (about 92 days)
Number of Participants Who Developed Bronchopulmonary Dysplasia
Measured: from randomization until discharge (about 92 days)
Number of Participants Who Developed Necrotizing Enterocolitis
Measured: from randomization until discharge (about 92 days)
Number of Days of Life at Which Infant Starting Taking All Feeds by Mouth
Measured: from randomization until discharge (about 92 days)
Length of Hospital Stay
Measured: from admission to hospital until discharge (about 92 days)
Number of Participants Who Developed Air Leak Disorders
Air leak disorders include pneumothorax, pneumomediastinum, and pulmonary interstitial emphysema.
Measured: from randomization until discharge (about 92 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study start19 Sep 2017
- Primary completion1 Mar 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Apnea of PrematurityStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amir Mustafa Khan, The University of Texas Health Science Center, Houston
- Investigators
- Brittany Duyka, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03292562
- Sponsor's protocol ID
- HSC-MS-17-0334
- Status last verified
- Feb 2020
- First submitted
- 21 Sep 2017
- Last updated
- 17 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Methods of Discontinuing Nasal CPAP in Premature Infants <30 Weeks Gestation - a Feasibility Study
- ClinicalTrials.gov ID
- NCT03292562
- Acronym / sponsor ID
- HSC-MS-17-0334
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 19 Sep 2017 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 25 Sep 2017 (actual)
- Results
- Posted 17 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if among infants <30 weeks gestational age on nasal continuous positive airway pressure (NCPAP), whether discontinuing CPAP after gradual reduction in continuous positive airway pressure (CPAP) pressure leads to successful weaning off CPAP when compared to discontinuing CPAP without weaning pressure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Discontinue NCPAP after weaning pressures | Active comparator | Device: Discontinue NCPAP after weaning pressuresAfter randomization, CPAP pressure will be weaned by 1 every 24hours as long as the subjects continue to meet stability criteria after each wean, until CPAP of 4. If after decrease in CPAP pressure, the subject meets CPAP failure criteria pressure will be increased back to the previous level and after stabilization for 24 hours weaning process will be started again. Once the subject meets stability criteria on CPAP of 4, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1 Liter flow, 30% FiO2). |
| Discontinue NCPAP without weaning pressures | Active comparator | Device: Discontinue NCPAP without weaning pressuresAfter randomization, once the subject meets stability criteria, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1 Liter flow, 30% FiO2). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- All infants < 30 weeks by dates, on NCPAP therapy, on caffeine 10mg/kg daily
- Meet CPAP stability criteria for ≥ 12hours (CPAP 6 cm water (H2O), FiO2 </=0.25 and stable (to maintain sats 85-95%), Respiratory rate consistently less than 60, Mild to no subcostal/intercostal retractions, No Apnea or bradycardia event that requires bag mask ventilation, Less than 3 apnea/brady/desat episodes in any 1 hour period for previous 6 hours, Tolerated time off CPAP during routine CPAP care (~15 min)
Key exclusion criteria (3 listed)
- Major congenital anomalies including congenital heart disease
- Anomalies that prevent discontinuation of NCPAP
- Undergoing current evaluation for and/or treatment of sepsis
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 |
|---|---|---|
| Discontinue NCPAP after weaning pressuresAfter randomization, CPAP pressure will be weaned by 1 every 24hours as long as the subjects continue to meet stability criteria after each wean, until CPAP of 4. If after decrease in CPAP pressure, the subject meets CPAP failure criteria pressure will be increased back to the previous level and after stabilization for 24 hours weaning process will be started again. Once the subject meets stability criteria on CPAP of 4, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1 Liter flow, 30% FiO2). | Device | Discontinue NCPAP after weaning pressures |
| Discontinue NCPAP without weaning pressuresAfter randomization, once the subject meets stability criteria, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1 Liter flow, 30% FiO2). | Device | Discontinue NCPAP without weaning pressures |
Primary outcome
Number of Days on NCPAP or Mechanical Ventilation
Time frame: from randomization until 28 days post-randomization
Subjects might go on and off NCPAP or mechanical ventilation throughout the 28 days after randomization, and the total number of days will be reported.
7 secondary outcomes
Duration of Endotracheal Ventilation
Time frame: from randomization until 28 days post-randomization
Number of Participants Who Failed to Wean Off NCPAP
Time frame: from randomization until discharge (about 92 days)
Number of Participants Who Developed Bronchopulmonary Dysplasia
Time frame: from randomization until discharge (about 92 days)
Number of Participants Who Developed Necrotizing Enterocolitis
Time frame: from randomization until discharge (about 92 days)
Number of Days of Life at Which Infant Starting Taking All Feeds by Mouth
Time frame: from randomization until discharge (about 92 days)
Length of Hospital Stay
Time frame: from admission to hospital until discharge (about 92 days)
Number of Participants Who Developed Air Leak Disorders
Time frame: from randomization until discharge (about 92 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Brittany Duyka, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Discontinue NCPAP after weaning pressures and Discontinue NCPAP without weaning pressures in people with Apnea of Prematurity and Respiratory Distress Syndrome, run by The University of Texas Health Science Center, Houston 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 2 inclusion and 3 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 17 Mar 2020. 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?
Yes. Results are posted in the registry (first posted 17 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Days on NCPAP or Mechanical Ventilation (time frame: from randomization until 28 days post-randomization). 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 17 Mar 2020.