Apnea of PrematurityNCT03298035

A Comparison of Non-invasive Ventilation Methods Used to Prevent Endotracheal Intubation Due to Apnea in Very Low Birth Weight Infants

A study testing NCPAP as mode for apnea prevention and NIPPV as rescue mode for apnea prevention in people with Apnea of Prematurity, run by The University of Texas Health Science Center, Houston at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine whether nasal intermittent positive pressure ventilation (NIPPV) reduces the need for endotracheal intubation in very low birth weight infants with persistent apnea who fail nasal continuous positive airway pressure (NCPAP). Read more about this study

Who is it for?: Any age
Conditions the study is for: Apnea of Prematurity
What is being tested?: NCPAP as mode for apnea prevention and NIPPV as rescue mode for apnea prevention
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 19 participants
Where: 1 siteUnited States
Study dates: 11 Nov 2017to 31 Dec 2018
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

Infants born at < 30 weeks gestational age who develop clinically significant apnea while on NCPAP > 6cm H2O or whose team is considering intubation due to apnea. Consider clinically significant apnea as 1 or more events treated with bag-mask ventilation or 3 episodes of apnea requiring stimulation within 1 hour.
Infants on maximum caffeine therapy (10mg/kg/day)

Who cannot join

Major congenital anomalies including congenital heart disease

Trial locations and contacts

1 site in 1 country.

United States1 site

The University of Texas Health Science Center at Houston
Houston, Texas, 70030

Other trials in United States

About this study

Conditions: Apnea of Prematurity
Being tested: NCPAP as mode for apnea prevention, NIPPV as rescue mode for apnea prevention
Medical subject headings: Apnea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NCPAP as mode for apnea preventionDevice
With recurrence of apneic events, infants on NCPAP will have changes made in NCPAP settings per the clinical team's discretion in attempt to prevent future apneic events. If apneic events persist despite NCPAP adjustments, clinicians may intubate based on clinical judgment.
NIPPV as rescue mode for apnea preventionDevice
With recurrence of apneic events, infants will be placed on NIPPV with settings and adjustments per the clinical team's discretion. If apneic events persist despite NIPPV placement and setting adjustments, clinicians may intubate based on clinical judgment.

Study groups in NCT03298035
Study group	Role	What they receive
NCPAP as mode for apnea prevention	Active comparator	With recurrence of apneic events, infants on NCPAP will have changes made in NCPAP settings per the clinical team's discretion in attempt to prevent future apneic events. If apneic events persist despite NCPAP adjustments, clinicians may intubate based on clinical judgment. Receives: Device: NCPAP as mode for apnea prevention
NIPPV as rescue mode for apnea prevention	Experimental	With recurrence of apneic events, infants will be placed on NIPPV with settings and adjustments per the clinical team's discretion. If apneic events persist despite NIPPV placement and setting adjustments, clinicians may intubate based on clinical judgment. Receives: Device: NIPPV as rescue mode for apnea prevention

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Who Were Intubated
Measured: 28 days after randomization
Duration of Intubation
Measured: 28 days after randomization

Secondary outcomes (7)

Number of Apneic Events
Measured: 28 days after randomization
Number of Participants With Bronchopulmonary Dysplasia (BPD)
Measured: 36 weeks corrected gestational age
Number of Participants With Necrotizing Enterocolitis (NEC)
Measured: 36 weeks corrected gestational age
Number of Participants With Air Leak Disorders
Air leak disorders include pneumothorax and/or pneumomediastinum.
Measured: 36 weeks corrected gestational age
Weight Gain
Measured: 36 weeks corrected gestational age
Length of Hospital Stay
Measured: about 10 to 18 weeks
Number of Participants Who Died
Measured: until discharge (about 10 to 18 weeks) or death

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Nov 201731 Dec 2018

First posted29 Sep 2017
Study start11 Nov 2017
Primary completion31 Dec 2018
Study completion31 Dec 2018

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.
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: None (open label)
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03298035
Sponsor's protocol ID: HSC-MS-17-0458
Status last verified: Jan 2020
First submitted: 26 Sep 2017
Last updated: 7 Feb 2020
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Strap To Reduce Apnea in Preterm Infants: A Randomized Crossover Trial
Apnea of Prematurity, Intermittent Hypoxemia
Recruiting
Manual T-piece Versus Ventilator Positive Pressure Ventilation During Resuscitation of Extremely Premature Neonates
Neonatal Resuscitation, Apnea Neonatal
RecruitingObservational study
Post-Vent, the Sequelae: Personalized Prognostic Modeling for Consequences of Neonatal Intermittent Hypoxemia in Preterm Infants at Pre-School Age
Premature Birth, Asthma in Children
Not yet recruitingObservational study
Automated Apnoea Detection in Preterms on Non-invasive Ventilation
Apnoea, Prematurity
Not yet recruiting
MICropsampling for CAffeine in PREMature Newborns
Apnea of Prematurity

All Apnea of Prematurity trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Comparison of Non-invasive Ventilation Methods Used to Prevent Endotracheal Intubation Due to Apnea in Very Low Birth Weight Infants
ClinicalTrials.gov ID: NCT03298035
Acronym / sponsor ID: HSC-MS-17-0458
Conditions: Apnea of Prematurity
Study type: Interventional
Recruitment status: Completed
Enrolment: 19 participants (actual)
Lead sponsor: The University of Texas Health Science Center, HoustonUniversity, hospital or other
Study start: 11 Nov 2017 (actual)
Primary completion: 31 Dec 2018 (actual)
Study completion: 31 Dec 2018 (actual)
First posted: 29 Sep 2017 (actual)
Results: Posted 7 Feb 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
NCPAP as mode for apnea prevention	Active comparator	Device: NCPAP as mode for apnea preventionWith recurrence of apneic events, infants on NCPAP will have changes made in NCPAP settings per the clinical team's discretion in attempt to prevent future apneic events. If apneic events persist despite NCPAP adjustments, clinicians may intubate based on clinical judgment.
NIPPV as rescue mode for apnea prevention	Experimental	Device: NIPPV as rescue mode for apnea preventionWith recurrence of apneic events, infants will be placed on NIPPV with settings and adjustments per the clinical team's discretion. If apneic events persist despite NIPPV placement and setting adjustments, clinicians may intubate based on clinical judgment.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (2 listed)

Infants born at < 30 weeks gestational age who develop clinically significant apnea while on NCPAP > 6cm H2O or whose team is considering intubation due to apnea. Consider clinically significant apnea as 1 or more events treated with bag-mask ventilation or 3 episodes of apnea requiring stimulation within 1 hour.
Infants on maximum caffeine therapy (10mg/kg/day)

Key exclusion criteria (1 listed)

Major congenital anomalies including congenital heart disease

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
NCPAP as mode for apnea preventionWith recurrence of apneic events, infants on NCPAP will have changes made in NCPAP settings per the clinical team's discretion in attempt to prevent future apneic events. If apneic events persist despite NCPAP adjustments, clinicians may intubate based on clinical judgment.	Device	NCPAP as mode for apnea prevention
NIPPV as rescue mode for apnea preventionWith recurrence of apneic events, infants will be placed on NIPPV with settings and adjustments per the clinical team's discretion. If apneic events persist despite NIPPV placement and setting adjustments, clinicians may intubate based on clinical judgment.	Device	NIPPV as rescue mode for apnea prevention

Primary outcome

Number of Participants Who Were Intubated
Time frame: 28 days after randomization
Duration of Intubation
Time frame: 28 days after randomization

7 secondary outcomes

Number of Apneic Events
Time frame: 28 days after randomization
Number of Participants With Bronchopulmonary Dysplasia (BPD)
Time frame: 36 weeks corrected gestational age
Number of Participants With Necrotizing Enterocolitis (NEC)
Time frame: 36 weeks corrected gestational age
Number of Participants With Air Leak Disorders
Time frame: 36 weeks corrected gestational age
Weight Gain
Time frame: 36 weeks corrected gestational age
Length of Hospital Stay
Time frame: about 10 to 18 weeks
Number of Participants Who Died
Time frame: until discharge (about 10 to 18 weeks) or death

Results and safety

Results posted to the registry on 7 Feb 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
NIPPV as Rescue Mode for Apnea Prevention	10	9
NCPAP as Mode for Apnea Prevention	9	7

Primary outcome: Number of Participants Who Were Intubated

Time frame: 28 days after randomization. Count of participants. Unit: Participants

Measure	NIPPV as Rescue Mode for Apnea Prevention n = 10	NCPAP as Mode for Apnea Prevention n = 9
Value	6	8

Primary outcome: Duration of Intubation

Time frame: 28 days after randomization. Mean (Standard Deviation). Unit: days

Measure	NIPPV as Rescue Mode for Apnea Prevention n = 10	NCPAP as Mode for Apnea Prevention n = 9
Value	10.6 (10.2)	17.5 (11.4)

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: 28 days. Serious and other adverse events were considered as those specifically occurring during the 28-day intervention period; however, mortality was evaluated over the maximum of an 18 week duration. The patient death that occurred happened to be within the 28-day study period.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
NIPPV as Rescue Mode for Apnea Prevention	0 of 10 (0%)	0 of 10 (0%)	1 of 10
NCPAP as Mode for Apnea Prevention	0 of 9 (0%)	0 of 9 (0%)	0 of 9

Limitations and caveats (from the sponsor): This was a pragmatic trial with inherent bias, as blinding was not possible. There was a small sample size (intent was to enroll 50, but only a few of all screened qualified for escalation of care).

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Apnea of Prematurity

Not yet recruiting
Strap To Reduce Apnea in Preterm Infants: A Randomized Crossover Trial
Apnea of Prematurity, Intermittent Hypoxemia
Recruiting
Manual T-piece Versus Ventilator Positive Pressure Ventilation During Resuscitation of Extremely Premature Neonates
Neonatal Resuscitation, Apnea Neonatal
RecruitingObservational study
Post-Vent, the Sequelae: Personalized Prognostic Modeling for Consequences of Neonatal Intermittent Hypoxemia in Preterm Infants at Pre-School Age
Premature Birth, Asthma in Children
Not yet recruitingObservational study
Automated Apnoea Detection in Preterms on Non-invasive Ventilation
Apnoea, Prematurity
Not yet recruiting
MICropsampling for CAffeine in PREMature Newborns
Apnea of Prematurity

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.

Claire Beaullieu, 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?

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 1 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 7 Feb 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 7 Feb 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 Participants Who Were Intubated (time frame: 28 days after randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03298035.

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 7 Feb 2020.