Neonatal Electrical Activity at Different Altitude Levels

NCT ID: NCT05966714

Last Updated: 2025-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

531 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-12

Study Completion Date

2024-10-08

Brief Summary

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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.

Detailed Description

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Conditions

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Altitude Hypoxia Neonatal Encephalopathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Lijiang(2500m)

aEEG

Intervention Type DEVICE

amplitude-integrated electroencephalography

Group 2

Shangri-La (3500 m)

aEEG

Intervention Type DEVICE

amplitude-integrated electroencephalography

Interventions

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aEEG

amplitude-integrated electroencephalography

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

0 Hours

Maximum Eligible Age

72 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Children's Hospital of Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Yangfang Li

Kunming, Yunnan, China

Site Status

Children Hospital of Fudan University

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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20230509-z

Identifier Type: -

Identifier Source: org_study_id

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