Infant,PrematureNCT03445689
Oxygenation Instability and Maturation of Control of Breathing in Premature Infants
An observational study of Infant,Premature, run by University of Miami at 1 site in United States.
Trial summary
Premature infants present with significant oxygenation instability in the form of frequent spontaneous episodes of hypoxemia during the first weeks after birth. These infants are also exposed to hyperoxemia. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infant,Premature
- What is being tested?
- Assessment of oxygenation instability, Determination of mechanisms of hypoxemia episodes and Assessment of respiratory instability
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Sep 2018to 1 Nov 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Preterm infants admitted to the neonatal intensive care unit will be screened and will be considered eligible for inclusion if they fulfill all of the following inclusion and none of the exclusion criteria.
Who may be able to join
- Premature infants born at 23 0/7- 28 6/7 weeks gestational age
- Postnatal age up to equivalent to 36 weeks postmenstrual age
- Requiring supplemental oxygen and/or receiving mechanical ventilation, CPAP, nasal ventilation or nasal cannula
Who cannot join
- Severe congenital anomalies that may affect life expectancy or pulmonary or neurosensory development
- Severe CNS pathology that may alter respiratory control function
Trial locations and contacts
1 site in 1 country.
United States1 site
NICU at Holtz Children's Hospital
Miami, Florida, 33136
About this study
Premature infants present with significant oxygenation instability in the form of frequent spontaneous episodes of hypoxemia during the first weeks after birth. These infants are also exposed to hyperoxemia.
The objective of this study is to determine the extent to which exposure to frequent episodes of hypoxemia and hyperoxemia in extreme premature infants during the early stages of their evolving lung disease is associated with altered maturation and function of their respiratory control system.
This study is part of the Prematurity-Related Ventilatory Control (Pre-Vent): Role in Respiratory Outcomes Clinical Research Centers (CRC) (U01) cooperative program of the National Heart Lung and Blood Institute (NHLBI) of the National Institutes of Health (NIH).
Read the detailed description
Most extreme premature infants present with respiratory failure due to altered lung function compounded by breathing instability due to an immature respiratory control function.
Premature infants present with significant oxygenation instability in the form of frequent spontaneous episodes of hypoxemia during the first weeks after birth. As a result, these infants receive oxygen supplementation but this is often excessive and these infants are also exposed to hyperoxemia. The extent to which these episodes of hypoxemia or the exposure to hyperoxemia impact on the maturation and function of the control of breathing system in extreme premature infants during the evolving stages of their respiratory disease is unknown. This is a prospective study that will systematically evaluate such association in extreme premature infants.
The main objective of this study is to determine the extent to which exposure to frequent episodes of hypoxemia and hyperoxemia in extreme premature infants during the early stages of their evolving lung disease is associated with altered maturation and function of their respiratory control system.
This study is part of the Prematurity-Related Ventilatory Control (Pre-Vent): Role in Respiratory Outcomes Clinical Research Centers (CRC) (U01) cooperative program of the National Heart Lung and Blood Institute (NHLBI) of the National Institutes of Health (NIH).
- Conditions
- Infant,Premature
- Being tested
- Assessment of oxygenation instability, Determination of mechanisms of hypoxemia episodes, Assessment of respiratory instability, apneic threshold of CO2, Assessment of peripheral chemoreceptor function
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of oxygenation instabilityOther
Recordings of SpO2 and heart rate will be analyzed by dedicated software to obtain frequency, duration and severity of episodes of hypoxemia and hyperoxemia.
Determination of mechanisms of hypoxemia episodesOther
Recordings of SpO2, heart rate, esophageal pressure, tidal volume, minute volume, respiratory rate and transcutaneous PCO2 will be analyzed to determine the prevalence, severity and duration of hypoxemia episodes produced by the different mechanisms.
Assessment of respiratory instabilityOther
Recordings of tidal volume, minute volume and respiratory rate will be analyzed to determine frequency of apnea, periodic breathing, distribution of inter-breath intervals.
apneic threshold of CO2Other
In mechanically ventilated infants the apneic threshold of CO2 will be measured by transcutaneous PCO2 following a step wise increase in ventilator rate until spontaneous breathing ceases transiently. In spontaneously breathing infants the apnea threshold of CO2 will be measured during episodes central apnea.
Assessment of peripheral chemoreceptor functionOther
Also called Dejours test
The Dejours test will be used to assess peripheral chemoreceptor function by measuring the immediate ventilatory response to high-inspired oxygen.
Assessment of central chemo-receptor functionOther
Also called Ventilatory response to CO2
Central chemo-receptor function will be assessed by measuring the ventilatory response to inspired CO2.
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripheral chemoreceptor control of breathing function
Ventilatory response to oxygen (Dejours test)
Measured: at 32 weeks corrected postmenstrual age
Peripheral chemoreceptor control of breathing function
Ventilatory response to oxygen (Dejours test)
Measured: at 36 weeks corrected postmenstrual age
Central chemoreceptor control of breathing function
Ventilatory response to carbon dioxide
Measured: at 32 weeks corrected postmenstrual age
Central chemoreceptor control of breathing function
Ventilatory response to carbon dioxide
Measured: at 36 weeks corrected postmenstrual age
Change in peripheral chemoreceptor control of breathing function
Ventilatory response to oxygen (Dejours test)
Measured: Change from 32 to 36 weeks postmenstrual age
Change in central chemoreceptor control of breathing function
Ventilatory response to carbon dioxide
Measured: Change from 32 to 36 weeks postmenstrual age
Secondary outcomes (6)
Ventilatory stability - Apnea frequency
Frequency of apnea episodes per hour
Measured: at 32 and 36 weeks corrected postmenstrual age
Ventilatory stability - Periodic breathing density
Percent of time with periodic breathing
Measured: at 32 and 36 weeks corrected postmenstrual age
Ventilatory stability - Time series analysis of inter-breath interval
Tail slope of the log-scaled probability density function of the inter-breath time series
Measured: at 32 and 36 weeks corrected postmenstrual age
Mechanisms of episodic hypoxemia
Classify etiology of episodes of hypoxemia as central, obstructive, or mixed apnea or active exhalation based on measurements of respiratory inductance plethysmography, esophageal pressure
Measured: at 32 and 36 weeks corrected postmenstrual age
Apneic CO2 threshold in central apnea
Carbon dioxide level change at onset of central apnea
Measured: at 32 and 36 weeks corrected postmenstrual age
Apneic CO2 threshold during mechanical ventilation
Carbon dioxide level change at onset of central apnea with stepwise increase in ventilator rate
Measured: at 32 and 36 weeks corrected postmenstrual age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2018
- Study start4 Sep 2018
- Primary completion1 Nov 2023
- Study completion1 Nov 2023
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 MiamiThe 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Nelson Claure, University of Miami
- Investigators
- Nelson Claure, Principal investigator, University of MiamiEduardo Bancalari, Principal investigator, University of MiamiDeepak Jain, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03445689
- Sponsor's protocol ID
- 20161114
- Other IDs
- U01HL133689
- Status last verified
- Mar 2025
- First submitted
- 6 Feb 2018
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Claure N, Tolosa J, Jain D, Schott A, Aguilar AC, Dormishian A, Bancalari E. Effect of Intermittent Hypoxemia and Hyperoxemia during the Neonatal Period on Control of Breathing Function among Infants Born Extremely Preterm. J Pediatr. 2025 Jun;281:114542. doi: 10.1016/j.jpeds.2025.114542. Epub 2025 Mar 14.
PubMed 40090544
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxygenation Instability and Maturation of Control of Breathing in Premature Infants
- ClinicalTrials.gov ID
- NCT03445689
- Acronym / sponsor ID
- 20161114
- Conditions
- Infant,Premature
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 4 Sep 2018 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 26 Feb 2018 (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.
Premature infants present with significant oxygenation instability in the form of frequent spontaneous episodes of hypoxemia during the first weeks after birth. These infants are also exposed to hyperoxemia.
The objective of this study is to determine the extent to which exposure to frequent episodes of hypoxemia and hyperoxemia in extreme premature infants during the early stages of their evolving lung disease is associated with altered maturation and function of their respiratory control system.
This study is part of the Prematurity-Related Ventilatory Control (Pre-Vent): Role in Respiratory Outcomes Clinical Research Centers (CRC) (U01) cooperative program of the National Heart Lung and Blood Institute (NHLBI) of the National Institutes of Health (NIH).
Detailed description
Most extreme premature infants present with respiratory failure due to altered lung function compounded by breathing instability due to an immature respiratory control function.
Premature infants present with significant oxygenation instability in the form of frequent spontaneous episodes of hypoxemia during the first weeks after birth. As a result, these infants receive oxygen supplementation but this is often excessive and these infants are also exposed to hyperoxemia. The extent to which these episodes of hypoxemia or the exposure to hyperoxemia impact on the maturation and function of the control of breathing system in extreme premature infants during the evolving stages of their respiratory disease is unknown. This is a prospective study that will systematically evaluate such association in extreme premature infants.
The main objective of this study is to determine the extent to which exposure to frequent episodes of hypoxemia and hyperoxemia in extreme premature infants during the early stages of their evolving lung disease is associated with altered maturation and function of their respiratory control system.
This study is part of the Prematurity-Related Ventilatory Control (Pre-Vent): Role in Respiratory Outcomes Clinical Research Centers (CRC) (U01) cooperative program of the National Heart Lung and Blood Institute (NHLBI) of the National Institutes of Health (NIH).
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Preterm infants admitted to the neonatal intensive care unit will be screened and will be considered eligible for inclusion if they fulfill all of the following inclusion and none of the exclusion criteria.
Key inclusion criteria (3 listed)
- Premature infants born at 23 0/7- 28 6/7 weeks gestational age
- Postnatal age up to equivalent to 36 weeks postmenstrual age
- Requiring supplemental oxygen and/or receiving mechanical ventilation, CPAP, nasal ventilation or nasal cannula
Key exclusion criteria (2 listed)
- Severe congenital anomalies that may affect life expectancy or pulmonary or neurosensory development
- Severe CNS pathology that may alter respiratory control function
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 |
|---|---|---|
| Assessment of oxygenation instabilityRecordings of SpO2 and heart rate will be analyzed by dedicated software to obtain frequency, duration and severity of episodes of hypoxemia and hyperoxemia. | Other | – |
| Determination of mechanisms of hypoxemia episodesRecordings of SpO2, heart rate, esophageal pressure, tidal volume, minute volume, respiratory rate and transcutaneous PCO2 will be analyzed to determine the prevalence, severity and duration of hypoxemia episodes produced by the different mechanisms. | Other | – |
| Assessment of respiratory instabilityRecordings of tidal volume, minute volume and respiratory rate will be analyzed to determine frequency of apnea, periodic breathing, distribution of inter-breath intervals. | Other | – |
| apneic threshold of CO2In mechanically ventilated infants the apneic threshold of CO2 will be measured by transcutaneous PCO2 following a step wise increase in ventilator rate until spontaneous breathing ceases transiently. In spontaneously breathing infants the apnea threshold of CO2 will be measured during episodes central apnea. | Other | – |
| Assessment of peripheral chemoreceptor functionAlso: Dejours testThe Dejours test will be used to assess peripheral chemoreceptor function by measuring the immediate ventilatory response to high-inspired oxygen. | Other | – |
| Assessment of central chemo-receptor functionAlso: Ventilatory response to CO2Central chemo-receptor function will be assessed by measuring the ventilatory response to inspired CO2. | Other | – |
Primary outcome
Peripheral chemoreceptor control of breathing function
Time frame: at 32 weeks corrected postmenstrual age
Ventilatory response to oxygen (Dejours test)
Peripheral chemoreceptor control of breathing function
Time frame: at 36 weeks corrected postmenstrual age
Ventilatory response to oxygen (Dejours test)
Central chemoreceptor control of breathing function
Time frame: at 32 weeks corrected postmenstrual age
Ventilatory response to carbon dioxide
Central chemoreceptor control of breathing function
Time frame: at 36 weeks corrected postmenstrual age
Ventilatory response to carbon dioxide
Change in peripheral chemoreceptor control of breathing function
Time frame: Change from 32 to 36 weeks postmenstrual age
Ventilatory response to oxygen (Dejours test)
Change in central chemoreceptor control of breathing function
Time frame: Change from 32 to 36 weeks postmenstrual age
Ventilatory response to carbon dioxide
6 secondary outcomes
Ventilatory stability - Apnea frequency
Time frame: at 32 and 36 weeks corrected postmenstrual age
Ventilatory stability - Periodic breathing density
Time frame: at 32 and 36 weeks corrected postmenstrual age
Ventilatory stability - Time series analysis of inter-breath interval
Time frame: at 32 and 36 weeks corrected postmenstrual age
Mechanisms of episodic hypoxemia
Time frame: at 32 and 36 weeks corrected postmenstrual age
Apneic CO2 threshold in central apnea
Time frame: at 32 and 36 weeks corrected postmenstrual age
Apneic CO2 threshold during mechanical ventilation
Time frame: at 32 and 36 weeks corrected postmenstrual 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 18 Mar 2025.
- Derived from this study: PubMed 40090544Claure N, Tolosa J, Jain D, Schott A, Aguilar AC, Dormishian A, Bancalari E. Effect of Intermittent Hypoxemia and Hyperoxemia during the Neonatal Period on Control of Breathing Function among Infants Born Extremely Preterm. J Pediatr. 2025 Jun;281:114542. doi: 10.1016/j.jpeds.2025.114542. Epub 2025 Mar 14.
- Individual participant dataSharing planned: No
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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.
Nelson Claure principal investigator
University of Miami
Eduardo Bancalari principal investigator
University of Miami
Deepak Jain principal investigator
University of Miami
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 Miami 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 18 Mar 2025. 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?
Peripheral chemoreceptor control of breathing function (time frame: at 32 weeks corrected postmenstrual age). The study lists 6 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 NCT03445689, 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 18 Mar 2025.