Tissue OxygenationTCBTOUNACOIVPINCT06483867
The Correlation Between Tissue Oxygenations Using NIRS and Clinical Outcomes in Very Preterm Infants.
An observational study of Tissue Oxygenation, run by The First Hospital of Jilin University.
Trial summary
With the development of neonatal critical medicine, the survival rate of premature infants has gradually increased, and the incidence of late complications has significantly decreased, but preterm delivery is still the main cause of death of children in China. Read more about this study
- Who is it for?
- Ages 0 to 24 hoursHealthy volunteers can take part
- Conditions the study is for
- Tissue Oxygenation
- How many people
- 151 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 1 Jul 2025
- 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 0 to 24 hours
- All sexes
- Healthy volunteers accepted
- Child
Study population: (1) All infants born at <32 weeks of gestation. (2) Register and start NIRS monitoring within 24 hours after birth; (3) Obtain the written consent of parents.
Who may be able to join
- (1) All infants born at <32 weeks of gestation. (2) Register and start NIRS monitoring within 24 hours after birth; (3) Obtain the written consent of parents.
Who cannot join
- Potential sensor interference: Disorders of/nonkeratinized skin; Hydrops/anasarca; Severe jaundice; Chromosomal abnormality ；Severe congenital malformations； Parents refuse to participate
About this study
Official title: A Study of the Correlation Between NIRS Monitoring Early Postnatal Tissue Oxygen Saturation and Clinical Outcomes in Very Preterm Infants: A Single-center Prospective Cohort Study
With the development of neonatal critical medicine, the survival rate of premature infants has gradually increased, and the incidence of late complications has significantly decreased, but preterm delivery is still the main cause of death of children in China.
Near infrared spectroscopy (NIRS) makes use of the different absorption spectra of oxygenated and deoxyhemoglobin in the near infrared band to provide tissue oxygenation index, which is non-invasive and convenient. Due to the thin skin and bone of newborns, near infrared spectroscopy has a broad prospect and important significance in the field of newborns. Non-invasive, real-time and continuous monitoring of brain oxygenation, intestinal oxygenation and tissue perfusion of premature infants can provide doctors with important information support and auxiliary means, which can help to detect and deal with various complications in time and improve the survival rate and health status of premature infants. The current research is mainly focused on exploring the relationship between some specific indicators and corresponding diseases, but there is a lack of research on a series of complications related to premature infants, especially in very premature infants, due to the immaturity of multiple organ system development. They had a significantly higher risk of complications such as severe intraventricular hemorrhage, necrotizing enterocolitis (NEC), retinopathy of prematurity (ROP), bronchopulmonary dysplasia (BPD) and so on. However, there is a lack of cohort study on the prediction of early complications in such children. The purpose of this study is to further explore the changes of tissue oxygen saturation and related indexes in the early postnatal period and their relationship with related complications. It is assumed that the tissue oxygen saturation in the early postnatal period is related to the adverse outcome in hospital, so as to intervene the children early and reduce the occurrence of adverse outcome.
Read the detailed description
NIRS monitoring begins within 24 hours after birth. Oxygen saturation in the brain and intestines is monitored for 15 minutes at the same time every day. The probe should be fixed with medical tape and closed to the skin to avoid light leakage. At the same time, shading measures should be taken on the probe and skin surface to reduce the impact of environmental factors. Continuous monitoring for 7 days. If the infants start feeding during the period, monitor 15 minutes from 5 minutes before feeding, including before, during, and after feeding, and the relatively stable data at each time point was taken as the intestinal tissue oxygen saturation at that time, and the oxygen saturation variation and tissue oxygen extraction ratio are calculated. Clinical data were recorded at the time of each measurement and included feeding status and the use of mechanical ventilation, oxygen therapy, and medications and so on.
- Conditions
- Tissue Oxygenation
- Keywords
- Very preterm infants; composite outcome; Near-Infrared Spectroscopy; Tissue oxygenation
What is being measured
The primary outcome is the main question the study is designed to answer.
The composite outcome
death or any 1 of the following morbidities: bronchopulmonary dysplasia (BPD), retinopathy of prematurity ≥stage 3,periventricular leukomalacia, Necrotizing Enterocolitis≥stage II, and sepsis
Measured: 2023.12-2024.12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start1 Jul 2024 (estimated)
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tissue OxygenationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 151 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06483867
- Sponsor's protocol ID
- huiwu
- Acronym
- TCBTOUNACOIVPI
- Status last verified
- Feb 2024
- First submitted
- 26 Jun 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Correlation Between NIRS Monitoring Early Postnatal Tissue Oxygen Saturation and Clinical Outcomes in Very Preterm Infants: A Single-center Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06483867
- Acronym / sponsor ID
- TCBTOUNACOIVPI / huiwu
- Conditions
- Tissue Oxygenation
- Keywords
- Very preterm infants; composite outcome; Near-Infrared Spectroscopy; Tissue oxygenation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 151 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 3 Jul 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.
With the development of neonatal critical medicine, the survival rate of premature infants has gradually increased, and the incidence of late complications has significantly decreased, but preterm delivery is still the main cause of death of children in China.
Near infrared spectroscopy (NIRS) makes use of the different absorption spectra of oxygenated and deoxyhemoglobin in the near infrared band to provide tissue oxygenation index, which is non-invasive and convenient. Due to the thin skin and bone of newborns, near infrared spectroscopy has a broad prospect and important significance in the field of newborns. Non-invasive, real-time and continuous monitoring of brain oxygenation, intestinal oxygenation and tissue perfusion of premature infants can provide doctors with important information support and auxiliary means, which can help to detect and deal with various complications in time and improve the survival rate and health status of premature infants. The current research is mainly focused on exploring the relationship between some specific indicators and corresponding diseases, but there is a lack of research on a series of complications related to premature infants, especially in very premature infants, due to the immaturity of multiple organ system development. They had a significantly higher risk of complications such as severe intraventricular hemorrhage, necrotizing enterocolitis (NEC), retinopathy of prematurity (ROP), bronchopulmonary dysplasia (BPD) and so on. However, there is a lack of cohort study on the prediction of early complications in such children. The purpose of this study is to further explore the changes of tissue oxygen saturation and related indexes in the early postnatal period and their relationship with related complications. It is assumed that the tissue oxygen saturation in the early postnatal period is related to the adverse outcome in hospital, so as to intervene the children early and reduce the occurrence of adverse outcome.
Detailed description
NIRS monitoring begins within 24 hours after birth. Oxygen saturation in the brain and intestines is monitored for 15 minutes at the same time every day. The probe should be fixed with medical tape and closed to the skin to avoid light leakage. At the same time, shading measures should be taken on the probe and skin surface to reduce the impact of environmental factors. Continuous monitoring for 7 days. If the infants start feeding during the period, monitor 15 minutes from 5 minutes before feeding, including before, during, and after feeding, and the relatively stable data at each time point was taken as the intestinal tissue oxygen saturation at that time, and the oxygen saturation variation and tissue oxygen extraction ratio are calculated. Clinical data were recorded at the time of each measurement and included feeding status and the use of mechanical ventilation, oxygen therapy, and medications and so on.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 to 24 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- (1) All infants born at <32 weeks of gestation. (2) Register and start NIRS monitoring within 24 hours after birth; (3) Obtain the written consent of parents.
Key inclusion criteria (1 listed)
- (1) All infants born at <32 weeks of gestation. (2) Register and start NIRS monitoring within 24 hours after birth; (3) Obtain the written consent of parents.
Key exclusion criteria (1 listed)
- Potential sensor interference: Disorders of/nonkeratinized skin; Hydrops/anasarca; Severe jaundice; Chromosomal abnormality ；Severe congenital malformations； Parents refuse to participate
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
The composite outcome
Time frame: 2023.12-2024.12
death or any 1 of the following morbidities: bronchopulmonary dysplasia (BPD), retinopathy of prematurity ≥stage 3,periventricular leukomalacia, Necrotizing Enterocolitis≥stage II, and sepsis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Tissue Oxygenation, run by The First Hospital of Jilin University.
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 1 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: status not confirmed, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
The composite outcome (time frame: 2023.12-2024.12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jul 2024.