Neonatal Electrical Activity at Different Altitude Levels

NCT05966714 | Completed

• 1 other identifier: 20230509-z
• Study Type: observational
• Target: 531
• Locations: 1 country
• Sites: 2

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.

Conditions

Altitude Hypoxia; Neonatal Encephalopathy

Keywords

altitude; neonate; Amplitude integrated electroencephalography

Outcome Measures

Primary Outcomes (1)

• 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.

  within three days after birth

Secondary Outcomes (1)

• Establish reference values for each altitude level

  within three days after birth

Study Arms (2)

Group 1

Lijiang(2500m)

Device: aEEG

Group 2

Shangri-La (3500 m)

Device: aEEG

Interventions

aEEG DEVICE

amplitude-integrated electroencephalography

Group 1; Group 2

Eligibility Criteria

• Age: 0 Hours - 72 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Healthy neonates at different altitude levels

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (2)

Yangfang Li

Kunming, Yunnan, China

Location

Children Hospital of Fudan University

Shanghai, 201102, China

Location

MeSH Terms

Conditions

Altitude Sickness

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2023
• First Posted: August 1, 2023
• Study Start: June 12, 2023
• Primary Completion: June 1, 2024
• Study Completion: October 8, 2024
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)