High AltitudeNCT05115721
Establishing the Reference Interval for Pulse Oxygen Saturation in Neonates at High Altitude
An observational study of High Altitude, run by Nanjing Medical University at 1 site in China.
Trial summary
The now widely used reference interval for pulse oxygen saturation of the neonate after 24 hours of birth has been developed relying on data from low altitude.It is not suitable for neonates at high altitude. Read more about this study
- Who is it for?
- Ages 24 hours to 28 daysHealthy volunteers can take part
- Conditions the study is for
- High Altitude
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2022to 10 Feb 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 24 hours to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: All consecutively delivered and eligible neonates at the various medical centers at different altitudes during the study will be included. The study period is from November 20, 2021 to November 20, 2022.
Who may be able to join
- Healthy singleton term infants with no clinical signs and symptoms (e.g., cyanosis, respiratory distress, heart murmur, etc.).
Who cannot join
- 1. Low birth weight (< 2500 g). 2. Need for oxygen. 3.1 or 5 minute Apgar score < 7. 4. Referred to the neonatal intensive care unit or neonatology department for various reasons. 5. Neonates discharged within 24 hours of birth. 6. Neonates diagnosed with congenital diseases in utero. 7. Refusal of consent.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Qinghai Women and Children's Hospital
Xining, Qinghai, 810000
Chongde Liu, qhgc13389785420@126.com
About this study
Official title: A Prospective Study on Establishing the Reference Interval for Pulse Oxygen Saturation in Neonates at High Altitude
The now widely used reference interval for pulse oxygen saturation of the neonate after 24 hours of birth has been developed relying on data from low altitude.It is not suitable for neonates at high altitude. At present, no reference interval has been established at high altitude, and the existing studies have many limitations. So this study was designed.
Read the detailed description
Knowledge of the reference interval of pulse oxygen saturation (SpO2) in neonates is crucial for accurate identification of neonatal hypoxemia. The now widely used standard was derived from low altitude data, which is not suitable neonates at high altitude. At present, many scholars have paid attention to this problem. But, previous studies still have some limitations. For example, they often only focus on a specific altitude. However, with the increase of altitude, the pulse oxygen saturation decreases in a curve, so their study results are only suitable for this specific altitude and can not be widely used.
- Conditions
- High Altitude
- Being tested
- no intervention
- Medical subject headings
- Altitude Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
It's only observational study. No interventions.
| Study group | Role | What they receive |
|---|---|---|
| Pre-ductal SpO2 | Not described Receives: Other: no intervention | |
| Post-ductal SpO2 | Not described Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulse oxygen saturation of healthy neonates at high altitude.
Pulse oxygen saturation of the right hand and any foot of healthy neonates born at high altitude will be measured 24 hours after birth. According to the normality of the results, the distribution range will be described by mean ± standard deviation or range interquartile. Altitude level: ≥ 2000m.
Measured: 24 hours after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2021
- Study start1 Feb 2022
- Primary completion1 Feb 2023 (estimated)
- Study completion10 Feb 2023 (estimated)
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 High AltitudeStudies 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
- Cross-sectional
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Affiliated Hospital of Qinghai University, Qinghai Red Cross Hospital, Qinghai Women and Children's Hospital, Geermu People's Hospital, Yushu Prefecture People's Hospital, Guoluo Tibetan Autonomous Prefecture People's Hospital
- Responsible party
- Principal investigator, Zhangbin Yu, The Second Clinical Medical College of Jinan University
- Investigators
- Zhangbin Yu, PHD, Principal investigator, Jinan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05115721
- Sponsor's protocol ID
- NMU-FY2021-59
- Status last verified
- Feb 2022
- First submitted
- 30 Oct 2021
- Last updated
- 3 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang B, Liu C, Yao Y, Lu Z, Yu R, CaiRen Z, Wang Z, Liu R, Wu Y, Yu Z. Establishing the reference interval for pulse oxygen saturation in neonates at high altitudes: protocol for a multicentre, open, cross-sectional study. BMJ Open. 2022 Apr 22;12(4):e060444. doi: 10.1136/bmjopen-2021-060444.
PubMed 35459680
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study on Establishing the Reference Interval for Pulse Oxygen Saturation in Neonates at High Altitude
- ClinicalTrials.gov ID
- NCT05115721
- Acronym / sponsor ID
- NMU-FY2021-59
- Conditions
- High Altitude
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Affiliated Hospital of Qinghai University, Qinghai Red Cross Hospital, Qinghai Women and Children's Hospital, Geermu People's Hospital, Yushu Prefecture People's Hospital, Guoluo Tibetan Autonomous Prefecture People's Hospital
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Feb 2023 (estimated)
- Study completion
- 10 Feb 2023 (estimated)
- First posted
- 10 Nov 2021 (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 now widely used reference interval for pulse oxygen saturation of the neonate after 24 hours of birth has been developed relying on data from low altitude.It is not suitable for neonates at high altitude. At present, no reference interval has been established at high altitude, and the existing studies have many limitations. So this study was designed.
Detailed description
Knowledge of the reference interval of pulse oxygen saturation (SpO2) in neonates is crucial for accurate identification of neonatal hypoxemia. The now widely used standard was derived from low altitude data, which is not suitable neonates at high altitude. At present, many scholars have paid attention to this problem. But, previous studies still have some limitations. For example, they often only focus on a specific altitude. However, with the increase of altitude, the pulse oxygen saturation decreases in a curve, so their study results are only suitable for this specific altitude and can not be widely used.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-ductal SpO2 | – | Other: no intervention |
| Post-ductal SpO2 | – | Other: no intervention |
Who may qualify
- Ages
- 24 hours to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- All consecutively delivered and eligible neonates at the various medical centers at different altitudes during the study will be included. The study period is from November 20, 2021 to November 20, 2022.
Key inclusion criteria (1 listed)
- Healthy singleton term infants with no clinical signs and symptoms (e.g., cyanosis, respiratory distress, heart murmur, etc.).
Key exclusion criteria (1 listed)
- 1. Low birth weight (< 2500 g). 2. Need for oxygen. 3.1 or 5 minute Apgar score < 7. 4. Referred to the neonatal intensive care unit or neonatology department for various reasons. 5. Neonates discharged within 24 hours of birth. 6. Neonates diagnosed with congenital diseases in utero. 7. Refusal of consent.
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 |
|---|---|---|
| no interventionIt's only observational study. No interventions. | Other | Post-ductal SpO2, Pre-ductal SpO2 |
Primary outcome
Pulse oxygen saturation of healthy neonates at high altitude.
Time frame: 24 hours after birth
Pulse oxygen saturation of the right hand and any foot of healthy neonates born at high altitude will be measured 24 hours after birth. According to the normality of the results, the distribution range will be described by mean ± standard deviation or range interquartile. Altitude level: ≥ 2000m.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2022.
- Derived from this study: PubMed 35459680Wang B, Liu C, Yao Y, Lu Z, Yu R, CaiRen Z, Wang Z, Liu R, Wu Y, Yu Z. Establishing the reference interval for pulse oxygen saturation in neonates at high altitudes: protocol for a multicentre, open, cross-sectional study. BMJ Open. 2022 Apr 22;12(4):e060444. doi: 10.1136/bmjopen-2021-060444.
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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.
Zhangbin Yu, PHD principal investigator
Jinan University
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 High Altitude, run by Nanjing Medical University at 1 site in China.
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 Mar 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhangbin Yu, PHD (+86-025-52226567, yuzhangbin@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulse oxygen saturation of healthy neonates at high altitude. (time frame: 24 hours after birth). 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 NCT05115721, 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 3 Mar 2022.