Altitude HypoxiaNCT05966714
Neonatal Electrical Activity at Different Altitude Levels
An observational study of Altitude Hypoxia and Neonatal Encephalopathy, run by Children's Hospital of Fudan University at 2 sites in China.
Trial summary
In this study, the objective is to compare neonatal cerebral electrical activity within 3 days after birth across different altitude areas using amplitude-integrated electroencephalography (aEEG), and establish reference value for each altitude level. Read more about this study
- Who is it for?
- Ages 0 to 72 hoursHealthy volunteers can take part
- Conditions the study is for
- Altitude Hypoxia, Neonatal Encephalopathy
- What is being tested?
- aEEG
- Type of treatment
- Medical device
- How many people
- 531 participants
- Where
- 2 sitesChina
- Study dates
- 12 Jun 2023to 8 Oct 2024
- 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 72 hours
- All sexes
- Healthy volunteers accepted
- Child
Study population: Healthy neonates at different altitude levels
Who may be able to join
- Singleton term infants (gestational age between 37 0/7 and 41 6/7 weeks) born in the participating hospital.
- Infants appear well as defined by normal vital signs (heart rate ranging from 110 to 180 beats/min, respiratory rate ranging from 30 to 60 breaths/min, temperature ranging from 36.5°C to 37.5°C), absence of signs of illness such as cyanosis, respiratory distress and heart murmur.
- The mother is permanent residence of the current altitude level and live in the study area for the entire duration of pregnancy.
Who cannot join
- Need for supplemental oxygen or assisted ventilation.
- Any evidence of intrauterine distress such as meconium-stained amniotic fluid, Apgar score <7 at 1 or 5 min.
- Referred to neonatal intensive care unit or neonatology department for any reason other than observation.
- With major congenital anomaly.
- Probes cannot be properly placed due to scalp lesions or hematomas.
- Reject or withdraw from the study.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Yangfang Li
Kunming, Yunnan
Children Hospital of Fudan University
Shanghai, 201102
About this study
Official title: Neonatal Electrical Activity at Different Altitude Levels: A Prospective Observational Cohort Study
In this study, the objective is to compare neonatal cerebral electrical activity within 3 days after birth across different altitude areas using amplitude-integrated electroencephalography (aEEG), and establish reference value for each altitude level.
- Conditions
- Altitude Hypoxia, Neonatal Encephalopathy
- Being tested
- aEEG
- Keywords
- altitude, neonate, Amplitude integrated electroencephalography
- Medical subject headings
- Altitude Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aEEGDevice
amplitude-integrated electroencephalography
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Lijiang(2500m) Receives: Device: aEEG | |
| Group 2 | Shangri-La (3500 m) Receives: Device: aEEG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in aEEG indicators in neonates within three days after birth at different altitudes
aEEG data are acquired by aEEG device. This minimum and maximum value is used as the preliminary smoothing value for that specific time point. Next, a three-order low-pass filter is employed to further refine the preliminary values, and a phase compensation algorithm is applied to restore temporal information and obtain smoothed boundaries.For further analyzing the aEEG data, a total of 63 signal features were extracted to reflect the spectral density aspects by the Auto-Neo-EEG pipeline.
Measured: within three days after birth
Secondary outcomes (1)
Establish reference values for each altitude level
If significant differences exist across altitude levels, the 3rd, 10th, 50th, 75th, 90th, and 97th percentile for upper and lower threshold of aEEG will be established for each group separately. Otherwise a combined reference interval will be provided using the average value of lower limit value.
Measured: within three days after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start12 Jun 2023
- Primary completion1 Jun 2024
- Study completion8 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Altitude HypoxiaStudies 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
- 531 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05966714
- Sponsor's protocol ID
- 20230509-z
- Status last verified
- Feb 2025
- First submitted
- 14 Jun 2023
- Last updated
- 19 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neonatal Electrical Activity at Different Altitude Levels: A Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT05966714
- Acronym / sponsor ID
- 20230509-z
- Conditions
- Altitude Hypoxia, Neonatal Encephalopathy
- Keywords
- altitude, neonate, Amplitude integrated electroencephalography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 531 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 12 Jun 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 8 Oct 2024 (actual)
- First posted
- 1 Aug 2023 (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.
In this study, the objective is to compare neonatal cerebral electrical activity within 3 days after birth across different altitude areas using amplitude-integrated electroencephalography (aEEG), and establish reference value for each altitude level.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Device: aEEGLijiang(2500m) |
| Group 2 | – | Device: aEEGShangri-La (3500 m) |
Who may qualify
- Ages
- 0 to 72 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy neonates at different altitude levels
Key inclusion criteria (3 listed)
- Singleton term infants (gestational age between 37 0/7 and 41 6/7 weeks) born in the participating hospital.
- Infants appear well as defined by normal vital signs (heart rate ranging from 110 to 180 beats/min, respiratory rate ranging from 30 to 60 breaths/min, temperature ranging from 36.5°C to 37.5°C), absence of signs of illness such as cyanosis, respiratory distress and heart murmur.
- The mother is permanent residence of the current altitude level and live in the study area for the entire duration of pregnancy.
Key exclusion criteria (6 listed)
- Need for supplemental oxygen or assisted ventilation.
- Any evidence of intrauterine distress such as meconium-stained amniotic fluid, Apgar score <7 at 1 or 5 min.
- Referred to neonatal intensive care unit or neonatology department for any reason other than observation.
- With major congenital anomaly.
- Probes cannot be properly placed due to scalp lesions or hematomas.
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 |
|---|---|---|
| aEEGamplitude-integrated electroencephalography | Device | Group 1, Group 2 |
Primary outcome
Differences in aEEG indicators in neonates within three days after birth at different altitudes
Time frame: within three days after birth
aEEG data are acquired by aEEG device. This minimum and maximum value is used as the preliminary smoothing value for that specific time point. Next, a three-order low-pass filter is employed to further refine the preliminary values, and a phase compensation algorithm is applied to restore temporal information and obtain smoothed boundaries.For further analyzing the aEEG data, a total of 63 signal features were extracted to reflect the spectral density aspects by the Auto-Neo-EEG pipeline.
1 secondary outcome
Establish reference values for each altitude level
Time frame: within three days after birth
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 19 Feb 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Altitude Hypoxia and Neonatal Encephalopathy, run by Children's Hospital of Fudan University at 2 sites 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 3 inclusion and 6 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 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Differences in aEEG indicators in neonates within three days after birth at different altitudes (time frame: within three days after birth). 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 19 Feb 2025.