Infant, PrematurePre-VentNCT03174301
Prematurity-Related Ventilatory Control: Role in Respiratory Outcomes
An observational study of Infant, Premature, run by University of Virginia at 1 site in United States.
Trial summary
The objective of this common multicenter protocol is to test the hypothesis that algorithmic tools using clinical Neonatal Intensive Care Unit (NICU) cardiorespiratory monitoring data can detect ventilatory control instability and predict chronic and acute respiratory consequences of ventilatory control instability… Read more about this study
- Who is it for?
- Ages Up to 1 week
- Conditions the study is for
- Infant, Premature
- How many people
- 739 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2018to 4 Jun 2021
- Phase
- Observational
- 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 Up to 1 week
- All sexes
- No healthy volunteers
- Child
Study population: All races and ethnicities will be recruited and distribution is expected to be similar to the populations represented in the NICU at each site. Age of all infants will be less than 29 weeks Gestational Age and less than 1 week Chronological Age, at the time of enrollment. The study population will be drawn from inpatients in NICUs at participating hospital sites with cardiorespiratory monitoring. The subjects will be in variable states of health since they are premature and in the intensive care unit. There will be no pre-screening of infants. Data will be collected on all infants placed in a bed for which monitoring and data collection capabilities are set up. Therefore all such infants will technically be enrolled in the study, regardless of meeting the inclusion/exclusion criteria. Each enrolled infant will be screened for inclusion/exclusion criteria to determine whether the site will collect further data from the medical record.
Who may be able to join
- Neonatal Intensive Care Unit patient on cardiorespiratory monitor which has been configured to collect data to store for this study
- < 29 wks Gestational Age
- < 1 wk Chronological
Who cannot join
- Unlikely to survive or decision not to pursue full care
- Major congenital or chromosomal anomaly
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22908
About this study
The objective of this common multicenter protocol is to test the hypothesis that algorithmic tools using clinical Neonatal Intensive Care Unit (NICU) cardiorespiratory monitoring data can detect ventilatory control instability and predict chronic and acute respiratory consequences of ventilatory control instability and autonomic dysregulation.
- Conditions
- Infant, Premature
- Medical subject headings
- Premature Birth
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Outcome
"Favorable": Either (1) an inpatient at 40 weeks post-menstrual age and not on oxygen, nor on other flow/pressure respiratory support, nor on inhaled/oral/IV respiratory medications, OR (2) discharged prior to 40 weeks post-menstrual age not on respiratory meds, oxygen, or other respiratory support.
"Unfavorable": Either (1) Deceased at 40 weeks , (2) inpatient on meds/O2/support at 40 weeks post-menstrual age, or (3) previously discharged prior to 40 weeks on meds/O2/support
Measured: 40 weeks post-menstrual age.
Physiological Outcome
Reported Value will be the percentile value of scores, as plotted on a standard curve of scores for peers. The score is calculated by aggregating the following measurements:
- Periodic Breathing Percentage (%)
- Number of Apnea events (#)
- Number of Bradycardia events (#)
- Number of Desaturation events (#)
- Number of combined events (example Apnea with Bradycardia and Desaturation (#)
Measured: 36 weeks and 1 day to 37 weeks and 0 days, post-menstrual age
Secondary outcomes (5)
time on respiratory support and medications
Measured: before 52 weeks post-menstrual age
chronic lung disease
Measured: before 52 weeks post-menstrual age
pulmonary hypertension
Measured: before 52 weeks post-menstrual age
sepsis
Measured: before 52 weeks post-menstrual age
necrotizing enterocolitis
Measured: before 52 weeks post-menstrual age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2017
- Study start9 Mar 2018
- Primary completion4 Jun 2021
- Study completion4 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 VirginiaThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 739 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- Case Western Reserve University, Northwestern University, University of Alabama at Birmingham, University of Miami, Washington University School of Medicine, National Heart, Lung, and Blood Institute (NHLBI), Brown University
- Responsible party
- Principal investigator, Joseph R Moorman, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03174301
- Sponsor's protocol ID
- 19606
- Other IDs
- U01HL133708
- Acronym
- Pre-Vent
- Status last verified
- Nov 2022
- First submitted
- 19 May 2017
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data and linked DNA samples will be stored at NHLBI Biorepository BIO-LINCC. Data will include continuous cardio-respiratory monitoring, demographics, clinical events, co-morbidities, respiratory status, and other clinical data.
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 39147903Kausch SL, Lake DE, Di Fiore JM, Weese-Mayer DE, Claure N, Ambalavanan N, Vesoulis ZA, Fairchild KD, Dennery PA, Hibbs AM, Martin RJ, Indic P, Travers CP, Bancalari E, Hamvas A, Kemp JS, Carroll JL, Moorman JR, Sullivan BA; Prematurity-Related Ventilatory Control (Pre-Vent) Investigators. Apnea, Intermittent Hypoxemia, and Bradycardia Events Predict Late-Onset Sepsis in Infants Born Extremely Preterm. J Pediatr. 2024 Aug;271:114042. doi: 10.1016/j.jpeds.2024.114042. Epub 2024 Apr 2.
PubMed 38570031Kausch SL, Lake DE, Di Fiore JM, Weese-Mayer DE, Claure N, Ambalavanan N, Vesoulis ZA, Fairchild KD, Dennery PA, Hibbs AM, Martin RJ, Indic P, Travers CP, Bancalari E, Hamvas A, Kemp JS, Carroll JL, Moorman JR, Sullivan BA; Prematurity-Related Ventilatory Control (Pre-Vent) Investigators. Apnea, Intermittent Hypoxemia, and Bradycardia Events Predict Late-Onset Sepsis in Extremely Preterm Infants. medRxiv [Preprint]. 2024 Jan 27:2024.01.26.24301820. doi: 10.1101/2024.01.26.24301820.
PubMed 38343825
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prematurity-Related Ventilatory Control: Role in Respiratory Outcomes
- ClinicalTrials.gov ID
- NCT03174301
- Acronym / sponsor ID
- Pre-Vent / 19606
- Conditions
- Infant, Premature
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 739 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- Case Western Reserve University, Northwestern University, University of Alabama at Birmingham, University of Miami, Washington University School of Medicine, National Heart, Lung, and Blood Institute (NHLBI), Brown University
- Study start
- 9 Mar 2018 (actual)
- Primary completion
- 4 Jun 2021 (actual)
- Study completion
- 4 Jun 2021 (actual)
- First posted
- 2 Jun 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.
The objective of this common multicenter protocol is to test the hypothesis that algorithmic tools using clinical Neonatal Intensive Care Unit (NICU) cardiorespiratory monitoring data can detect ventilatory control instability and predict chronic and acute respiratory consequences of ventilatory control instability and autonomic dysregulation.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 1 week
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All races and ethnicities will be recruited and distribution is expected to be similar to the populations represented in the NICU at each site. Age of all infants will be less than 29 weeks Gestational Age and less than 1 week Chronological Age, at the time of enrollment. The study population will be drawn from inpatients in NICUs at participating hospital sites with cardiorespiratory monitoring. The subjects will be in variable states of health since they are premature and in the intensive care unit. There will be no pre-screening of infants. Data will be collected on all infants placed in a bed for which monitoring and data collection capabilities are set up. Therefore all such infants will technically be enrolled in the study, regardless of meeting the inclusion/exclusion criteria. Each enrolled infant will be screened for inclusion/exclusion criteria to determine whether the site will collect further data from the medical record.
Key inclusion criteria (3 listed)
- Neonatal Intensive Care Unit patient on cardiorespiratory monitor which has been configured to collect data to store for this study
- < 29 wks Gestational Age
- < 1 wk Chronological
Key exclusion criteria (2 listed)
- Unlikely to survive or decision not to pursue full care
- Major congenital or chromosomal anomaly
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical Outcome
Time frame: 40 weeks post-menstrual age.
"Favorable": Either (1) an inpatient at 40 weeks post-menstrual age and not on oxygen, nor on other flow/pressure respiratory support, nor on inhaled/oral/IV respiratory medications, OR (2) discharged prior to 40 weeks post-menstrual age not on respiratory meds, oxygen, or other respiratory support. "Unfavorable": Either (1) Deceased at 40 weeks , (2) inpatient on meds/O2/support at 40 weeks post-menstrual age, or (3) previously discharged prior to 40 weeks on meds/O2/support
Physiological Outcome
Time frame: 36 weeks and 1 day to 37 weeks and 0 days, post-menstrual age
Reported Value will be the percentile value of scores, as plotted on a standard curve of scores for peers. The score is calculated by aggregating the following measurements: 1. Periodic Breathing Percentage (%) 2. Number of Apnea events (#) 3. Number of Bradycardia events (#) 4. Number of Desaturation events (#) 5. Number of combined events (example Apnea with Bradycardia and Desaturation (#)
5 secondary outcomes
time on respiratory support and medications
Time frame: before 52 weeks post-menstrual age
chronic lung disease
Time frame: before 52 weeks post-menstrual age
pulmonary hypertension
Time frame: before 52 weeks post-menstrual age
sepsis
Time frame: before 52 weeks post-menstrual age
necrotizing enterocolitis
Time frame: before 52 weeks post-menstrual age
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 2 Nov 2022.
- 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.
- Derived from this study: PubMed 38570031Kausch SL, Lake DE, Di Fiore JM, Weese-Mayer DE, Claure N, Ambalavanan N, Vesoulis ZA, Fairchild KD, Dennery PA, Hibbs AM, Martin RJ, Indic P, Travers CP, Bancalari E, Hamvas A, Kemp JS, Carroll JL, Moorman JR, Sullivan BA; Prematurity-Related Ventilatory Control (Pre-Vent) Investigators. Apnea, Intermittent Hypoxemia, and Bradycardia Events Predict Late-Onset Sepsis in Infants Born Extremely Preterm. J Pediatr. 2024 Aug;271:114042. doi: 10.1016/j.jpeds.2024.114042. Epub 2024 Apr 2.
- Derived from this study: PubMed 38343825Kausch SL, Lake DE, Di Fiore JM, Weese-Mayer DE, Claure N, Ambalavanan N, Vesoulis ZA, Fairchild KD, Dennery PA, Hibbs AM, Martin RJ, Indic P, Travers CP, Bancalari E, Hamvas A, Kemp JS, Carroll JL, Moorman JR, Sullivan BA; Prematurity-Related Ventilatory Control (Pre-Vent) Investigators. Apnea, Intermittent Hypoxemia, and Bradycardia Events Predict Late-Onset Sepsis in Extremely Preterm Infants. medRxiv [Preprint]. 2024 Jan 27:2024.01.26.24301820. doi: 10.1101/2024.01.26.24301820.
- Individual participant dataSharing planned: Yes. De-identified data and linked DNA samples will be stored at NHLBI Biorepository BIO-LINCC. Data will include continuous cardio-respiratory monitoring, demographics, clinical events, co-morbidities, respiratory status, and other clinical data.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infant, Premature, run by University of Virginia 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 3 inclusion and 2 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 2 Nov 2022. 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?
Clinical Outcome (time frame: 40 weeks post-menstrual age.). 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 NCT03174301, which also lists 3 linked publications.
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 2 Nov 2022.