POX Range and the Threshold for Screening Major CHD in Neonates at Different Altitudes
NCT ID: NCT04238104
Last Updated: 2021-07-28
Study Results
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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COMPLETED
2200 participants
OBSERVATIONAL
2020-02-01
2021-04-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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sea level
Pulse oximetry was performed between 6 and 72 hours after delivery (measured and recorded at 6, 12, 24, 48 and 72 hours respectively). Using Masimo Radical-7 (Irvine, CA, USA) to measure. All measurements at the medical center of sea level were performed by the well-trained investigator. All major CHD infants will be measured the POX by the same way during the whole study period.
no intervention
it's only observational study. No interventions.
altitude <1000
Pulse oximetry was performed between 6 and 72 hours after delivery (measured and recorded at 6, 12, 24, 48 and 72 hours respectively). Using Masimo Radical-7 (Irvine, CA, USA) to measure. All measurements at the medical center with the altitude less than 1000 metres were performed by the well-trained investigator. All major CHD infants will be measured the POX by the same way during the whole study period.
no intervention
it's only observational study. No interventions.
altitude 1000-2000
Pulse oximetry was performed between 6 and 72 hours after delivery (measured and recorded at 6, 12, 24, 48 and 72 hours respectively). Using Masimo Radical-7 (Irvine, CA, USA) to measure. All measurements at the medical center with the altitude between 1000-2000 metres were performed by the well-trained investigator. All major CHD infants will be measured the POX by the same way during the whole study period.
no intervention
it's only observational study. No interventions.
altitude 2000-3000
Pulse oximetry was performed between 6 and 72 hours after delivery (measured and recorded at 6, 12, 24, 48 and 72 hours respectively). Using Masimo Radical-7 (Irvine, CA, USA) to measure. All measurements at the medical center with the altitude between 2000-3000 metres were performed by the well-trained investigator. All major CHD infants will be measured the POX by the same way during the whole study period.
no intervention
it's only observational study. No interventions.
altitude 3000-4000
Pulse oximetry was performed between 6 and 72 hours after delivery (measured and recorded at 6, 12, 24, 48 and 72 hours respectively). Using Masimo Radical-7 (Irvine, CA, USA) to measure. All measurements at the medical center with the altitude between 3000-4000 metres were performed by the well-trained investigator. All major CHD infants will be measured the POX by the same way during the whole study period.
no intervention
it's only observational study. No interventions.
altitude 4000-5000
Pulse oximetry was performed between 6 and 72 hours after delivery (measured and recorded at 6, 12, 24, 48 and 72 hours respectively). Using Masimo Radical-7 (Irvine, CA, USA) to measure. All measurements at the medical center with the altitude between 4000-5000 metres were performed by the well-trained investigator. All major CHD infants will be measured the POX by the same way during the whole study period.
no intervention
it's only observational study. No interventions.
Interventions
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no intervention
it's only observational study. No interventions.
Eligibility Criteria
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Inclusion Criteria
* Healthy, asymptomatic, singleton term infants (37-41 weeks gestation);
* Appropriate for gestational age (using the international WHO's intrauterine growth curve to evaluate);
* Only newborns with Apgar score ≥ 7 in 1 minute and 5 minutes were selected;
* There is no known congenital heart disease based on the ECHO result , no murmur, no obvious signs (no fever, no tachycardia or respiratory symptoms at the time of admission).
For major CHD newborns:
* Echocardiography clearly diagnosed the following congenital heart diseases: Aortic stenosis, Double outlet of right ventricle, Ebstein's malformation, Left cardiac hypoplasia syndrome, Aortic arch disconnection, Pulmonary atresia, Single ventricle, Tetralogy of Fallot, Complete anomalous pulmonary venous drainage, Transposition of great arteries, Tricuspid valve atresia, and Single trunk of arteries and other major CHD based on Ewer's denition.
Exclusion Criteria
* Newborn with caesarean section; newborn with smoking mother; newborn with definite congenital heart disease before discharge.
For major CHD newborns:
28 Days
ALL
No
Sponsors
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Hainan women and children medical center
UNKNOWN
People's Hospital of Xinjiang Uygur Autonomous Region
OTHER
Yan'an Affiliated Hospital of Kunming Medical University
OTHER
Qinghai Red Cross Hospital
OTHER
Tibet Autonomous Region People's Hospital
OTHER
People's Hospital of Golog Tibetan Autonomous Prefecture
UNKNOWN
People's Hospital of Naqu District, Tibet
UNKNOWN
People's Hospital of Luchun County, Yunnan Province
UNKNOWN
Children's Hospital of Fudan University
OTHER
Responsible Party
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Principal Investigators
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Weili Yan, PhD
Role: STUDY_CHAIR
Epidemiology Office of Children's hospital of Fudan University
Locations
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People's Hospital of Golog Tibetan Autonomous Prefecture
Guoluo Prefecture, , China
Hainan women and children medical center
Haikou, , China
Yan'an Hospital Affiliated to Kunming Medical University
Kunming, , China
Tibet Autonomous People's Hospital
Lhasa, , China
People's Hospital of Luchun County, Yunnan Province
Luchun, , China
People's Hospital of Naqu District, Tibet
Naqu, , China
Qinghai Red Cross Hospital
Qinghai, , China
People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, , China
Countries
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Other Identifiers
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2019-296
Identifier Type: -
Identifier Source: org_study_id
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