Neonatal Electrical Activity at Different Altitude Levels

Completed

• Conditions: Altitude Hypoxia; Neonatal Encephalopathy
• Interventions: Device: NIRS; Device: aEEG

• Registration Number: NCT05966714
• Lead Sponsor: Children's Hospital of Fudan University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-12
• Study First Submitted: 2023-06-14
• Study First Submitted QC: 2023-07-28
• Study First Posted: 2023-08-01
• Primary Completion: 2024-06-01
• Study Completion: 2024-10-08
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-16
• Last Update Posted: 2025-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 531

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	aEEG	Nujiang (880m)
Group 3	aEEG	Lijiang(2500m)
Group 2	aEEG	Kunming(1800m)
Group 3	NIRS	Lijiang(2500m)
Group 1	NIRS	Nujiang (880m)
Group 2	NIRS	Kunming(1800m)
Group 4	NIRS	Shangri-La (3500 m)
Group 4	aEEG	Shangri-La (3500 m)

Primary Outcome Measures

Name	Time	Method
Differences in aEEG indicators in neonates within three days after birth at different altitudes	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 Outcome Measures

Name	Time	Method
Establish reference values for each altitude level	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.

Trial Locations

Locations (2)

Yangfang Li; 🇨🇳 Kunming, Yunnan, China

Children Hospital of Fudan University; 🇨🇳 Shanghai, China