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Completed

NCT Number: NCT05966714

Neonatal Electrical Activity at Different Altitude Levels

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.

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Key information

Conditions

Altitude Hypoxia Altitude Sickness Neonatal Encephalopathy Respiration Disorders Respiratory Tract Diseases

Age range

0 hour–72 hour

Sex eligibility

All sexes

Study type

Observational

Primary location

Yangfang Li, Kunming, Yunnan, China

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

aEEG

Device

amplitude-integrated electroencephalography

Primary outcomes

  1. 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.

Secondary outcomes

  1. Establish reference values for each altitude level

    Time frame: within three days after birth

    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.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 1, 2023
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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