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Neonatal Electrical Activity at Different Altitude Levels

Neonatal Electrical Activity at Different Altitude Levels: A Prospective Observational Cohort Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05966714
Enrollment
531
Registered
2023-08-01
Start date
2023-06-12
Completion date
2024-10-08
Last updated
2025-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Altitude Hypoxia, Neonatal Encephalopathy

Keywords

altitude, neonate, Amplitude integrated electroencephalography

Brief 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.

Interventions

DEVICEaEEG

amplitude-integrated electroencephalography

Sponsors

Children's Hospital of Fudan University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Hours to 72 Hours
Healthy volunteers
Yes

Inclusion criteria

1. Singleton term infants (gestational age between 37 0/7 and 41 6/7 weeks) born in the participating hospital. 2. 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. 3. The mother is permanent residence of the current altitude level and live in the study area for the entire duration of pregnancy.

Exclusion criteria

1. Need for supplemental oxygen or assisted ventilation. 2. Any evidence of intrauterine distress such as meconium-stained amniotic fluid, Apgar score \<7 at 1 or 5 min. 3. Referred to neonatal intensive care unit or neonatology department for any reason other than observation. 4. With major congenital anomaly. 5. Probes cannot be properly placed due to scalp lesions or hematomas. 6. Reject or withdraw from the study.

Design outcomes

Primary

MeasureTime frameDescription
Differences in aEEG indicators in neonates within three days after birth at different altitudeswithin three days after birthaEEG 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.

Secondary

MeasureTime frameDescription
Establish reference values for each altitude levelwithin three days after birthIf 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026