Neonatal Cerebral Oxygenation and Electrical Activity at Different Altitude Levels

Sponsor

Children's Hospital of Fudan University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05966714

Collaborator

(none)

170

Enrollment

Location

Anticipated Duration (Months)

18.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In this study, the objective is to compare neonatal cerebral oxygenation and electrical activity within 3 days after birth across different altitude areas using non-invasive methods, specifically near infrared spectroscopy (NIRS) and amplitude-integrated electroencephalography (aEEG), and establish reference value for each altitude level.

Condition or Disease	Intervention/Treatment	Phase
Altitude Hypoxia Neonatal Encephalopathy	Device: NIRS Device: aEEG

Study Design

Study Type:

Observational

Anticipated Enrollment :

170 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 30, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Mar 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Group 1 Nujiang (880m)	Device: NIRS cerebral oxygenation and electrical activity monitoring Device: aEEG amplitude-integrated electroencephalography
Group 2 Kunming(1800m)	Device: NIRS cerebral oxygenation and electrical activity monitoring Device: aEEG amplitude-integrated electroencephalography
Group 3 Lijiang(2500m)	Device: NIRS cerebral oxygenation and electrical activity monitoring Device: aEEG amplitude-integrated electroencephalography
Group 4 Shangri-La (3500 m)	Device: NIRS cerebral oxygenation and electrical activity monitoring Device: aEEG amplitude-integrated electroencephalography

Outcome Measures

Primary Outcome Measures

Differences in cerebral oxygenation in neonates within three days after birth at different altitudes [within three days after birth]
Cerebral regional oxygen saturation (crSO2 in percentage) is measured by NIRS device.

Secondary Outcome Measures

Differences in tissue oxygen extraction in neonates within three days after birth at different altitudes [within three days after birth]
Tissue oxygen extraction (TOE in percentage) was calculated as TOE=SpO2- crSO2.
Differences in cerebral fractional tissue oxygen extraction in neonates within three days after birth at different altitudes [within three days after birth]
Cerebral fractional tissue oxygen extraction (cFTOE) is calculated as cFTOE = TOE/ SpO2.
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.The active sleep (AS) and quiet sleep (QS) cyclical pattern is recognized as periodic changes in the band-width of the aEEG tracing, with narrower and lower periods for AS and broader and higher periods for QS. For further analyzing the aEEG data, a total of 722 signal features were extracted to reflect the amplitude, rEEG, spectral density, and connectivity-related aspects by the Auto-Neo-EEG pipeline.
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 crSO2, 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

0 Hours to 72 Hours

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.