Hypoxemia of NewbornNCT06535074
Lung Function Monitoring During Hypoxemia Episodes
An observational study of Hypoxemia of Newborn, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
Premature infants commonly have desaturation episodes due to different reasons such as cessation of breathing or loss of lung volume. The purpose of this study is to differentiate the mechanisms of desaturation episodes with continuous lung volume monitoring. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypoxemia of Newborn
- What is being tested?
- Detecting changes in lung volume with hypoxemia episodes
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2024to 4 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: All infants admitted to the neonatal intensive care unit at Bristol Myers Squibb Children's Hospital and meeting eligibility criteria will be considered for enrollment and parents will be approached for informed consent.
Who may be able to join
- Born at ≤32w GA
- Post menstrual age between 30w to 36w
- 4 or more episodes of HEs in the previous 24h (Defined as SpO2<90≥5s)
Who cannot join
- Major congenital malformation
- Receiving invasive mechanical ventilation
- Severe neurological injury
- Hemodynamic instability requiring inotropes in last 72h
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Bristol Myers Squibbs Childrens Hospital
New Brunswick, New Jersey, 08901
Deepak Jain, MD
About this study
Official title: Differentiating Pathophysiological Mechanisms of Hypoxemia Episodes by Continuous Lung Function Monitoring in Preterm Infants
Premature infants commonly have desaturation episodes due to different reasons such as cessation of breathing or loss of lung volume. The purpose of this study is to differentiate the mechanisms of desaturation episodes with continuous lung volume monitoring. As we better understand the mechanisms underlying the desaturation episodes, newer strategies directed at underlying pathophysiology can potentially by evaluated for mitigation of these episodes.
Read the detailed description
This is an observational study evaluating changes in lung volume during hypoxemia episodes (HEs or desaturation episodes) in spontaneously breathing very preterm infants. We postulate that HEs can be differentiated into distinct subtypes based on alterations in lung volume. Additionally, the severity and duration of HEs correlates with the degree of changes in lung volumes. Therefore, we are performing an observational study in very preterm infants with spontaneous HEs and classifying these episodes into different subtypes of Apnea, forced exhalation, mixed, and unclassified subtypes according to changes in lung volume. Lung volume will be measured non-invasively using electrical impedance tomography (EIT) device (Sentec Inc, RI, USA). In brief, the device consists of a soft belt with 32 embedded electrodes which is placed around the chest of the infant and applies a weak alternating current and measures returning voltage. The measured returning voltage is dependent on the electrical conductivity of the underlying tissue. The reconstruction algorithm creates an image of regional impedance distribution in real time. These data are then used to compute lung volume parameters at different phases of respiratory cycle providing end expiratory lung impedance reflective of EELV, tidal impedance reflective of tidal volume, and regional distribution of ventilation. The changes in lung volume parameters will be used to differentiate HEs into different subtypes and correlated with degree and severity of HEs. In addition, we will also measure cerebral tissue oxygen saturation (CrSO2) to monitor changes in tissue oxygenation with hypoxemia episodes and changes in lung volume.
- Conditions
- Hypoxemia of Newborn
- Being tested
- Detecting changes in lung volume with hypoxemia episodes
- Keywords
- electrical impedance tomography, hypoxemia episodes, lung volume
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Detecting changes in lung volume with hypoxemia episodesOther
Electrical impedance tomography (EIT) will be used to assess changes in lung aeration prior and during hypoxemia episodes to classify them into four different subtypes.
FE subtype: Defined as HEs preceded by reduction in EELI below the baseline.
Apnea subtype: Defined as HEs not meeting the criteria for FE subtype and preceded by cessation of breathing.
Mixed subtype: Defined as HEs meeting the criteria for both FE and apnea subtypes.
Unclassified: Defined as HEs not categorized into any of the above parameters.
| Study group | Role | What they receive |
|---|---|---|
| Preterm infants with hypoxemia episodes | Very preterm infants with spontaneous HEs and not receiving invasive mechanical ventilation. Receives: Other: Detecting changes in lung volume with hypoxemia episodes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of hypoxemia episodes of each subtype
Hypoxemia episodes classified into 4 subtypes of Apnea, forced exhalation, mixed and unclassified according to changes in lung volume parameters.
Measured: 6 hour
Secondary outcomes (3)
Frequency of each subtype of episode with severe hypoxemia, prolonged episode, bradycardia
Severe HEs defined as SpO2<80, Prolonged HEs duration>=30s, Bradycardia HR<100 for >=5s
Measured: 6hr
Number of episodes of forced exhalation, apnea not meeting the criteria for hypoxemia episodes
Episodes meeting the EIT criteria for FE and apnea but not associated with HEs
Measured: 6hr
Mean highest change in CrSO2 and cFToE during HEs and each subtype
Change in CrSO2 from baseline and fTOE during HEs
Measured: 6hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start4 Apr 2024
- Primary completion4 Aug 2027 (estimated)
- Study completion4 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hypoxemia of NewbornStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deepak Jain. MD, Rutgers, The State University of New Jersey
- Investigators
- Deepak Jain, MD, Principal investigator, Rutgers Robert Wood Johnson Medical School Department of Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06535074
- Sponsor's protocol ID
- Pro2023000655
- Status last verified
- May 2026
- First submitted
- 30 Jul 2024
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)
Publications
Bancalari E, Claure N. Respiratory Instability and Hypoxemia Episodes in Preterm Infants. Am J Perinatol. 2018 May;35(6):534-536. doi: 10.1055/s-0038-1637760. Epub 2018 Apr 25.
PubMed 29694990Bolivar JM, Gerhardt T, Gonzalez A, Hummler H, Claure N, Everett R, Bancalari E. Mechanisms for episodes of hypoxemia in preterm infants undergoing mechanical ventilation. J Pediatr. 1995 Nov;127(5):767-73. doi: 10.1016/s0022-3476(95)70171-0.
PubMed 7472834Esquer C, Claure N, D'Ugard C, Wada Y, Bancalari E. Role of abdominal muscles activity on duration and severity of hypoxemia episodes in mechanically ventilated preterm infants. Neonatology. 2007;92(3):182-6. doi: 10.1159/000102056. Epub 2007 Apr 27.
PubMed 17476118van der Burg PS, Miedema M, de Jongh FH, Frerichs I, van Kaam AH. Cross-sectional changes in lung volume measured by electrical impedance tomography are representative for the whole lung in ventilated preterm infants. Crit Care Med. 2014 Jun;42(6):1524-30. doi: 10.1097/CCM.0000000000000230.
PubMed 24561568Piraino T. An Introduction to the Clinical Application and Interpretation of Electrical Impedance Tomography. Respir Care. 2022 Jun;67(6):721-729. doi: 10.4187/respcare.09949.
PubMed 35606004
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differentiating Pathophysiological Mechanisms of Hypoxemia Episodes by Continuous Lung Function Monitoring in Preterm Infants
- ClinicalTrials.gov ID
- NCT06535074
- Acronym / sponsor ID
- Pro2023000655
- Conditions
- Hypoxemia of Newborn
- Keywords
- electrical impedance tomography, hypoxemia episodes, lung volume
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 4 Apr 2024 (actual)
- Primary completion
- 4 Aug 2027 (estimated)
- Study completion
- 4 Aug 2027 (estimated)
- First posted
- 2 Aug 2024 (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 commonly have desaturation episodes due to different reasons such as cessation of breathing or loss of lung volume. The purpose of this study is to differentiate the mechanisms of desaturation episodes with continuous lung volume monitoring. As we better understand the mechanisms underlying the desaturation episodes, newer strategies directed at underlying pathophysiology can potentially by evaluated for mitigation of these episodes.
Detailed description
This is an observational study evaluating changes in lung volume during hypoxemia episodes (HEs or desaturation episodes) in spontaneously breathing very preterm infants. We postulate that HEs can be differentiated into distinct subtypes based on alterations in lung volume. Additionally, the severity and duration of HEs correlates with the degree of changes in lung volumes. Therefore, we are performing an observational study in very preterm infants with spontaneous HEs and classifying these episodes into different subtypes of Apnea, forced exhalation, mixed, and unclassified subtypes according to changes in lung volume. Lung volume will be measured non-invasively using electrical impedance tomography (EIT) device (Sentec Inc, RI, USA). In brief, the device consists of a soft belt with 32 embedded electrodes which is placed around the chest of the infant and applies a weak alternating current and measures returning voltage. The measured returning voltage is dependent on the electrical conductivity of the underlying tissue. The reconstruction algorithm creates an image of regional impedance distribution in real time. These data are then used to compute lung volume parameters at different phases of respiratory cycle providing end expiratory lung impedance reflective of EELV, tidal impedance reflective of tidal volume, and regional distribution of ventilation. The changes in lung volume parameters will be used to differentiate HEs into different subtypes and correlated with degree and severity of HEs. In addition, we will also measure cerebral tissue oxygen saturation (CrSO2) to monitor changes in tissue oxygenation with hypoxemia episodes and changes in lung volume.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preterm infants with hypoxemia episodes | – | Other: Detecting changes in lung volume with hypoxemia episodesVery preterm infants with spontaneous HEs and not receiving invasive mechanical ventilation. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All infants admitted to the neonatal intensive care unit at Bristol Myers Squibb Children's Hospital and meeting eligibility criteria will be considered for enrollment and parents will be approached for informed consent.
Key inclusion criteria (3 listed)
- Born at ≤32w GA
- Post menstrual age between 30w to 36w
- 4 or more episodes of HEs in the previous 24h (Defined as SpO2<90≥5s)
Key exclusion criteria (4 listed)
- Major congenital malformation
- Receiving invasive mechanical ventilation
- Severe neurological injury
- Hemodynamic instability requiring inotropes in last 72h
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 |
|---|---|---|
| Detecting changes in lung volume with hypoxemia episodesElectrical impedance tomography (EIT) will be used to assess changes in lung aeration prior and during hypoxemia episodes to classify them into four different subtypes. FE subtype: Defined as HEs preceded by reduction in EELI below the baseline. Apnea subtype: Defined as HEs not meeting the criteria for FE subtype and preceded by cessation of breathing. Mixed subtype: Defined as HEs meeting the criteria for both FE and apnea subtypes. Unclassified: Defined as HEs not categorized into any of the above parameters. | Other | Preterm infants with hypoxemia episodes |
Primary outcome
Frequency of hypoxemia episodes of each subtype
Time frame: 6 hour
Hypoxemia episodes classified into 4 subtypes of Apnea, forced exhalation, mixed and unclassified according to changes in lung volume parameters.
3 secondary outcomes
Frequency of each subtype of episode with severe hypoxemia, prolonged episode, bradycardia
Time frame: 6hr
Number of episodes of forced exhalation, apnea not meeting the criteria for hypoxemia episodes
Time frame: 6hr
Mean highest change in CrSO2 and cFToE during HEs and each subtype
Time frame: 6hr
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Background: PubMed 29694990Bancalari E, Claure N. Respiratory Instability and Hypoxemia Episodes in Preterm Infants. Am J Perinatol. 2018 May;35(6):534-536. doi: 10.1055/s-0038-1637760. Epub 2018 Apr 25.
- Background: PubMed 7472834Bolivar JM, Gerhardt T, Gonzalez A, Hummler H, Claure N, Everett R, Bancalari E. Mechanisms for episodes of hypoxemia in preterm infants undergoing mechanical ventilation. J Pediatr. 1995 Nov;127(5):767-73. doi: 10.1016/s0022-3476(95)70171-0.
- Background: PubMed 17476118Esquer C, Claure N, D'Ugard C, Wada Y, Bancalari E. Role of abdominal muscles activity on duration and severity of hypoxemia episodes in mechanically ventilated preterm infants. Neonatology. 2007;92(3):182-6. doi: 10.1159/000102056. Epub 2007 Apr 27.
- Background: PubMed 24561568van der Burg PS, Miedema M, de Jongh FH, Frerichs I, van Kaam AH. Cross-sectional changes in lung volume measured by electrical impedance tomography are representative for the whole lung in ventilated preterm infants. Crit Care Med. 2014 Jun;42(6):1524-30. doi: 10.1097/CCM.0000000000000230.
- Background: PubMed 35606004Piraino T. An Introduction to the Clinical Application and Interpretation of Electrical Impedance Tomography. Respir Care. 2022 Jun;67(6):721-729. doi: 10.4187/respcare.09949.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)
Related trials for Hypoxemia of Newborn
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Post-Vent, the Sequelae: Personalized Prognostic Modeling for Consequences of Neonatal Intermittent Hypoxemia in Preterm Infants at Pre-School Age
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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.
Deepak Jain, MD principal investigator
Rutgers Robert Wood Johnson Medical School Department of Pediatrics
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 Hypoxemia of Newborn, run by Rutgers, The State University of New Jersey 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 4 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: looking for participants now, as of the sponsor's last update on 15 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Deepak Jain, MD (7322353377, dj392@rwjms.rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of hypoxemia episodes of each subtype (time frame: 6 hour). 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 NCT06535074, which also lists 5 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 15 May 2026.