POX Range and the Threshold for Screening Major CHD in Neonates at Different Altitudes

POX Range of Healthy Newborns at Different Altitudes Clinical Trial

Official title:

Study on the Normal Range of Pulse Oximetry and the Threshold for Screening Critical Congenital Heart Disease in Neonates at Different Altitudes in China

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04238104
• Other study ID #: 2019-296
• Status: Completed
• Start date: February 1, 2020
• Est. completion date: April 15, 2021

Study information

• Verified date: December 2020
• Source: Children's Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

major CHD (Congenital Heart Disease) screening by POX (pulse oximetry) in sea-level areas is not fit for low, medium and high altitude areas, but the normal range of pulse oximetry at different altitude areas has not been studied before, so the current screening technology can only be used in sea-level areas, but not for newborns in low, medium and high altitude areas. We need to carry out a research to clarify the range of POX and make sure the threshold of POX in major CHD screening in different altitude areas of China.

Description:

At present, the application of POX (pulse oximetry) in screening major CHD (congenital heart disease ) has been legislated in the United States. In China, the two indicators of POX plus auscultation of heart murmur for screening major CHD have also been promoted as national standards. There are differences in the POX range of newborns at different altitude areas, so the threshold of POX screening based on sea-level areas is not applicable to low, medium and high altitude areas. While the normal range of POX at different altitude areas has not been studied in detail, so the current screening strategy can only be used in sea-level areas, but not benefit newborns in low, medium and high altitude areas. In order to apply major CHD screening strategy better to cover the newborns all over the country, we need to clarify the range of POX at different altitude areas of China and make sure the threshold of POX in major CHD screening. We plan to carry out a multicenter study on the normal POX value range of healthy and asymptomatic term newborns 6-72 hours after delivery in medical centers with altitude of 500-1000; 1000-2000; 2000-3000; 3000-4000 and above 4000 meters. And compare the POX value at different altitude areas with that of newborns delivered in the maternity hospitals at sea level. And measure the POX value of newborns with major CHD in the same way. POX screening thresholds will be obtained at different altitude areas. We will test the hypothesis that POX of healthy newborns at different altitude areas is lower than that of healthy newborns at sea level, and POX threshold of major CHD screening is lower than that of sea level.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2200
• Est. completion date: April 15, 2021
• Est. primary completion date: April 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Days

Eligibility

Inclusion Criteria:

For healthy newborns:

• 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:

For healthy newborns:

• Newborn with caesarean section; newborn with smoking mother; newborn with definite congenital heart disease before discharge.

For major CHD newborns:

• There is no exclusion criteria for major CHD.

Related Conditions & MeSH terms

• POX Range of Healthy Newborns at Different Altitudes
• POX Threshold for Screening Major CHD in Neonates

Intervention

Other:
• no intervention
it's only observational study. No interventions.

Locations

Country	Name	City	State
China	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	Urumqi

Sponsors (9)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University	Hainan women and children medical center, People's Hospital of Golog Tibetan Autonomous Prefecture, People's Hospital of Luchun County, Yunnan Province, People's Hospital of Naqu District, Tibet, People's Hospital of Xinjiang Uygur Autonomous Region, Qinghai Red Cross Hospital, Tibet Autonomous Region People's Hospital, Yan'an Affiliated Hospital of Kunming Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulse oximetry of healthy newborns at 6th hour after birth at different altitudes	Pulse oximetry of healthy newborns at 6th hour after birth would be measured by monitor at 6th hour after birth and would be described by range interquartile in healthy neonates in hospitals with different altitudes.; Altitude levels :sea level, within 1000 meters above sea level, 1000 to 2000 meters above sea level, 2000 to 3000 meters above sea level, 3000 to 4000 meters above sea level and 4000 to 5000 meters above sea level.	At 6th hours after birth
Secondary	Pulse oximetry of healthy newborns at 12th hour after birth at different altitudes	Pulse oximetry of healthy newborns at 12th hour after birth would be measured by monitor at 12th hour after birth and would be described by range interquartile in healthy neonates in hospitals with different altitudes.; Altitude levels :sea level, within 1000 meters above sea level, 1000 to 2000 meters above sea level, 2000 to 3000 meters above sea level, 3000 to 4000 meters above sea level and 4000 to 5000 meters above sea level.	At 12th hours after birth
Secondary	Pulse oximetry of healthy newborns at 24th hour after birth at different altitudes	Pulse oximetry of healthy newborns at 24th hour after birth would be measured by monitor at 24th hour after birth and would be described by range interquartile in healthy neonates in hospitals with different altitudes.; Altitude levels :sea level, within 1000 meters above sea level, 1000 to 2000 meters above sea level, 2000 to 3000 meters above sea level, 3000 to 4000 meters above sea level and 4000 to 5000 meters above sea level.	At 24th hours after birth
Secondary	Pulse oximetry of healthy newborns at 48th hour after birth at different altitudes	Pulse oximetry of healthy newborns at 48th hour after birth would be measured by monitor at 48th hour after birth and would be described by range interquartile in healthy neonates in hospitals with different altitudes.; Altitude levels :sea level, within 1000 meters above sea level, 1000 to 2000 meters above sea level, 2000 to 3000 meters above sea level, 3000 to 4000 meters above sea level and 4000 to 5000 meters above sea level.	At 48th hours after birth
Secondary	Pulse oximetry of healthy newborns at 72th hour after birth at different altitudes	Pulse oximetry of healthy newborns at 72th hour after birth would be measured by monitor at 72th hour after birth and would be described by range interquartile in healthy neonates in hospitals with different altitudes.; Altitude levels :sea level, within 1000 meters above sea level, 1000 to 2000 meters above sea level, 2000 to 3000 meters above sea level, 3000 to 4000 meters above sea level and 4000 to 5000 meters above sea level.	At 72th hours after birth
Secondary	Pulse oximetry of newborns with critical congenital heart disease at 6th hour after birth at different altitudes	Pulse oximetry of critical congenital heart disease newborns at 6th hour after birth would be measured by monitor at 6th hour after birth and would be described by range interquartile in critical congenital heart disease neonates in hospitals with different altitudes.; Altitude levels :sea level, within 1000 meters above sea level, 1000 to 2000 meters above sea level, 2000 to 3000 meters above sea level, 3000 to 4000 meters above sea level and 4000 to 5000 meters above sea level.	At 6th hours after birth
Secondary	Pulse oximetry of newborns with critical congenital heart disease at 12th hour after birth at different altitudes	Pulse oximetry of critical congenital heart disease newborns at 12th hour after birth would be measured by monitor at 12th hour after birth and would be described by range interquartile in healthy neonates in hospitals with different altitudes.; Altitude levels :sea level, within 1000 meters above sea level, 1000 to 2000 meters above sea level, 2000 to 3000 meters above sea level, 3000 to 4000 meters above sea level and 4000 to 5000 meters above sea level.	At 12th hours after birth
Secondary	Pulse oximetry of newborns with critical congenital heart disease at 24th hour after birth at different altitudes	Pulse oximetry of critical congenital heart disease newborns at 24th hour after birth would be measured by monitor at 24th hour after birth and would be described by range interquartile in critical congenital heart disease neonates in hospitals with different altitudes.; Altitude levels :sea level, within 1000 meters above sea level, 1000 to 2000 meters above sea level, 2000 to 3000 meters above sea level, 3000 to 4000 meters above sea level and 4000 to 5000 meters above sea level.	At 24th hours after birth
Secondary	Pulse oximetry of newborns with critical congenital heart disease at 48th hour after birth at different altitudes	Pulse oximetry of critical congenital heart disease newborns at 48th hour after birth would be measured by monitor at 48th hour after birth and would be described by range interquartile in critical congenital heart disease neonates in hospitals with different altitudes.; Altitude levels :sea level, within 1000 meters above sea level, 1000 to 2000 meters above sea level, 2000 to 3000 meters above sea level, 3000 to 4000 meters above sea level and 4000 to 5000 meters above sea level.	At 48th hours after birth
Secondary	Pulse oximetry of newborns with critical congenital heart disease at 72th hour after birth at different altitudes	Pulse oximetry of critical congenital heart disease newborns at 72th hour after birth would be measured by monitor at 72th hour after birth and would be described by range interquartile in critical congenital heart disease neonates in hospitals with different altitudes.; Altitude levels :sea level, within 1000 meters above sea level, 1000 to 2000 meters above sea level, 2000 to 3000 meters above sea level, 3000 to 4000 meters above sea level and 4000 to 5000 meters above sea level.	At 72th hours after birth