Infant,PrematureNCT03333174
Prematurity Related Ventilatory Control (PRE-VENT) - Specific Aim 3
A study testing Cardiorespiratory monitoring in people with Infant,Premature, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
To determine if servo-controlled oxygen environment is associated with reduction in (a) bradycardia events, (b) hypoxemic time, (c) bradycardia time, (d) apneic episodes Read more about this study
- Who is it for?
- Ages 1 day to 98 days
- Conditions the study is for
- Infant,Premature
- What is being tested?
- Cardiorespiratory monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2018to 1 Jul 2021
- 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 1 day to 98 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Inborn infants weighing 401-1,000 grams on admission and/or 22w 0/7d to 28w 6/7d (<29 weeks) inclusive completed weeks of gestation
- Infants eligible for full care and resuscitation as necessary, and surviving beyond 24 h of age
- Enrollment in main study protocol (Aim 1 of PreVENT Apnea) at <1 week post-natal age
- This study will enroll the subset of infants from Aim 1 who are receiving oxygen supplementation at 32w and 36w PMA, and are not judged too unstable by the Attending neonatologist
- Informed consent from parent/guardian
Who cannot join
- Refusal or withdrawal of consent Major congenital malformations (e.g., not including patent ductus arteriosus, small hernia)
Trial locations and contacts
1 site in 1 country.
United States1 site
Regional Neonatal ICU and CCN, University of Alabama at Birmingham
Birmingham, Alabama, 35233
About this study
Official title: Prematurity-Related Ventilatory Control (PRE-VENT): Role in Respiratory Outcomes Clinical Research Centers (CRC) - Specific Aim 3
To determine if servo-controlled oxygen environment is associated with reduction in (a) bradycardia events, (b) hypoxemic time, (c) bradycardia time, (d) apneic episodes
Read the detailed description
This study will enroll the subset of infants enrolled in the main study (PreVENT Aim 1; 401-1000g at birth and/or 22w 0d-28w 6d; enrolled at <1 week postnatal age; eligible for full care and surviving beyond 24 hours, with informed consent; and with no major malformations) who are receiving oxygen supplementation at 32w and 36w postmenstrual age (PMA), and are not judged too unstable by the Attending neonatologist.
For infants on oxygen supplementation at 32w PMA, the investigators will use data from the 96 hours of intensive multiparametric physiologic monitoring at 32w PMA. For infants on oxygen supplementation at 36w PMA, we will use the 96 hours of intensive multiparametric physiologic monitoring at 36w PMA as well as data from the sleep study.
The first 24 hours of data collection will be the baseline data. Over the next 72 hours, the investigators will evaluate 3 interventions in a cross-over manner with the initial intervention (cannula or oxygen environment) randomly assigned: Intervention 1 (24-48h of data), Intervention 2 (48-72h of data) and Intervention 3 (72-96h of data).
- Conditions
- Infant,Premature
- Being tested
- Cardiorespiratory monitoring
- Keywords
- apnea of prematurity, bradycardia, hypoxemic episode, oxygen delivery
- Medical subject headings
- Premature Birth, Apnea, Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiorespiratory monitoringDiagnostic test
The investigators will use high resolution physiologic monitoring of Heart Rate, Respiratory Rate, Pulse oximetry, (and near-infrared monitoring as well as microcapnography in selected infants) to evaluate control of breathing (apnea, bradycardia, desaturations)
| Study group | Role | What they receive |
|---|---|---|
| Servo-controlled Oxygen Environment | Experimental | Oxygen will be provided by servo-controlled oxygen environment with adjustment of oxygen concentration (FiO2) to keep infant's oxygen saturation target range at 91-95% in a cross-over manner for 24 hours at a time, over a 4-day period, and use Cardiorespiratory Monitoring to evaluate control of breathing. Receives: Diagnostic Test: Cardiorespiratory monitoring |
| Nasal Cannula Oxygen | Active comparator | Oxygen will be provided by nasal cannula with adjustment of flow rate and FiO2 to keep infant's oxygen saturation target range at 91-95% in a cross-over manner for 24 hours at a time, over a 4-day period, and use Cardiorespiratory Monitoring to evaluate control of breathing. Receives: Diagnostic Test: Cardiorespiratory monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoxemic episode
Hypoxemic episode defined as as oxygen saturation by pulse oximetry (SpO2) <85% for >10 seconds
Measured: During 24 hour time periods with either intervention (nasal cannula vs. oxygen environment)
Secondary outcomes (3)
Bradycardic episode
Bradycardic episode defined as heart rate (HR) <100/min for >10 seconds
Measured: During 24 hour time periods with either intervention (nasal cannula vs. oxygen environment)
Apnea episodes
Apnea defined as Respiratory Rate (RR)=0 for >20 seconds, or RR=0 for >10 seconds + oxygen saturation by pulse oximetry (SpO2) <85% or heart rate (HR) <100/min
Measured: During 24 hour time periods with either intervention (nasal cannula vs. oxygen environment)
Hypoxemic time defined as duration of time with SpO2 <85%
Hypoxemic time defined as duration of time with SpO2 <85%
Measured: During 24 hour time periods with either intervention (nasal cannula vs. oxygen environment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start9 Apr 2018
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infant,PrematureStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- (b) The first 24h of the data collection will be the baseline data. Over the next 72h, we will evaluate 3 interventions in a cross-over manner: Intervention 1 (24-48h of data), Intervention 2 (48-72h), and Intervention 3 (72-96h; same as intervention 1). Initial intervention will be by random assignment (computer-generated). The intervention will be to provide oxygen either by nasal cannula or by servo-controlled oxygen environment, followed by cross-over to other intervention for 24h, and then back to original intervention.
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Namasivayam Ambalavanan, University of Alabama at Birmingham
- Investigators
- Namasivayam Ambalavanan, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03333174
- Sponsor's protocol ID
- UAB Neo 020
- Status last verified
- Sep 2021
- First submitted
- 2 Nov 2017
- Last updated
- 21 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Travers CP, Chahine R, Nakhmani A, Aban I, Carlo WA, Ambalavanan N. Control of breathing in preterm infants on incubator oxygen or nasal cannula oxygen. Pediatr Res. 2025 Feb;97(3):1166-1170. doi: 10.1038/s41390-024-03460-5. Epub 2024 Aug 15.
PubMed 39147903
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prematurity-Related Ventilatory Control (PRE-VENT): Role in Respiratory Outcomes Clinical Research Centers (CRC) - Specific Aim 3
- ClinicalTrials.gov ID
- NCT03333174
- Acronym / sponsor ID
- UAB Neo 020
- Conditions
- Infant,Premature
- Keywords
- apnea of prematurity, bradycardia, hypoxemic episode, oxygen delivery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 9 Apr 2018 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 6 Nov 2017 (actual)
- 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 determine if servo-controlled oxygen environment is associated with reduction in (a) bradycardia events, (b) hypoxemic time, (c) bradycardia time, (d) apneic episodes
Detailed description
This study will enroll the subset of infants enrolled in the main study (PreVENT Aim 1; 401-1000g at birth and/or 22w 0d-28w 6d; enrolled at <1 week postnatal age; eligible for full care and surviving beyond 24 hours, with informed consent; and with no major malformations) who are receiving oxygen supplementation at 32w and 36w postmenstrual age (PMA), and are not judged too unstable by the Attending neonatologist.
For infants on oxygen supplementation at 32w PMA, the investigators will use data from the 96 hours of intensive multiparametric physiologic monitoring at 32w PMA. For infants on oxygen supplementation at 36w PMA, we will use the 96 hours of intensive multiparametric physiologic monitoring at 36w PMA as well as data from the sleep study.
The first 24 hours of data collection will be the baseline data. Over the next 72 hours, the investigators will evaluate 3 interventions in a cross-over manner with the initial intervention (cannula or oxygen environment) randomly assigned: Intervention 1 (24-48h of data), Intervention 2 (48-72h of data) and Intervention 3 (72-96h of data).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- (b) The first 24h of the data collection will be the baseline data. Over the next 72h, we will evaluate 3 interventions in a cross-over manner: Intervention 1 (24-48h of data), Intervention 2 (48-72h), and Intervention 3 (72-96h; same as intervention 1). Initial intervention will be by random assignment (computer-generated). The intervention will be to provide oxygen either by nasal cannula or by servo-controlled oxygen environment, followed by cross-over to other intervention for 24h, and then back to original intervention.
| Arm | Type | Receives |
|---|---|---|
| Servo-controlled Oxygen Environment | Experimental | Diagnostic Test: Cardiorespiratory monitoringOxygen will be provided by servo-controlled oxygen environment with adjustment of oxygen concentration (FiO2) to keep infant's oxygen saturation target range at 91-95% in a cross-over manner for 24 hours at a time, over a 4-day period, and use Cardiorespiratory Monitoring to evaluate control of breathing. |
| Nasal Cannula Oxygen | Active comparator | Diagnostic Test: Cardiorespiratory monitoringOxygen will be provided by nasal cannula with adjustment of flow rate and FiO2 to keep infant's oxygen saturation target range at 91-95% in a cross-over manner for 24 hours at a time, over a 4-day period, and use Cardiorespiratory Monitoring to evaluate control of breathing. |
Who may qualify
- Ages
- 1 day to 98 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Inborn infants weighing 401-1,000 grams on admission and/or 22w 0/7d to 28w 6/7d (<29 weeks) inclusive completed weeks of gestation
- Infants eligible for full care and resuscitation as necessary, and surviving beyond 24 h of age
- Enrollment in main study protocol (Aim 1 of PreVENT Apnea) at <1 week post-natal age
- This study will enroll the subset of infants from Aim 1 who are receiving oxygen supplementation at 32w and 36w PMA, and are not judged too unstable by the Attending neonatologist
- Informed consent from parent/guardian
Key exclusion criteria (1 listed)
- Refusal or withdrawal of consent Major congenital malformations (e.g., not including patent ductus arteriosus, small hernia)
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 |
|---|---|---|
| Cardiorespiratory monitoringThe investigators will use high resolution physiologic monitoring of Heart Rate, Respiratory Rate, Pulse oximetry, (and near-infrared monitoring as well as microcapnography in selected infants) to evaluate control of breathing (apnea, bradycardia, desaturations) | Diagnostic test | Nasal Cannula Oxygen, Servo-controlled Oxygen Environment |
Primary outcome
Hypoxemic episode
Time frame: During 24 hour time periods with either intervention (nasal cannula vs. oxygen environment)
Hypoxemic episode defined as as oxygen saturation by pulse oximetry (SpO2) <85% for >10 seconds
3 secondary outcomes
Bradycardic episode
Time frame: During 24 hour time periods with either intervention (nasal cannula vs. oxygen environment)
Apnea episodes
Time frame: During 24 hour time periods with either intervention (nasal cannula vs. oxygen environment)
Hypoxemic time defined as duration of time with SpO2 <85%
Time frame: During 24 hour time periods with either intervention (nasal cannula vs. oxygen environment)
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 21 Sep 2021.
- Derived from this study: PubMed 39147903Travers CP, Chahine R, Nakhmani A, Aban I, Carlo WA, Ambalavanan N. Control of breathing in preterm infants on incubator oxygen or nasal cannula oxygen. Pediatr Res. 2025 Feb;97(3):1166-1170. doi: 10.1038/s41390-024-03460-5. Epub 2024 Aug 15.
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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.
Namasivayam Ambalavanan principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiorespiratory monitoring in people with Infant,Premature, run by University of Alabama at Birmingham 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 5 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 21 Sep 2021. 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?
Hypoxemic episode (time frame: During 24 hour time periods with either intervention (nasal cannula vs. oxygen environment)). 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 NCT03333174, which also lists 1 linked publication.
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 21 Sep 2021.