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

NCT04238104 | Completed DMC

• 1 other identifier: 2019-296
• Study Type: observational
• Target: 2,200
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

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

Keywords

Saturation; Cut-off value; Neonates; Altitude; POX; major CHD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Pulse oximetry of healthy newborns at 12th hour after birth at different altitudes

  At 12th hours after birth

• Pulse oximetry of healthy newborns at 24th hour after birth at different altitudes

  At 24th hours after birth

• Pulse oximetry of healthy newborns at 48th hour after birth at different altitudes

  At 48th hours after birth

• Pulse oximetry of healthy newborns at 72th hour after birth at different altitudes

  At 72th hours after birth

• Pulse oximetry of newborns with critical congenital heart disease at 6th hour after birth at different altitudes

  At 6th hours after birth

Study Arms (6)

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.

Other: no intervention

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.

Other: no intervention

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.

Other: no intervention

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.

Other: no intervention

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.

Other: no intervention

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.

Other: no intervention

Interventions

no intervention OTHER

it's only observational study. No interventions.

altitude 1000-2000; altitude 2000-3000; altitude 3000-4000; altitude 4000-5000; altitude <1000; sea level

Eligibility Criteria

• Age: Up to 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

During the study period (January 15, 2019 to December 15, 2020), all newborns in continuous delivery were included simultaneously in various medical centers in different altitude areas. For major CHD infants, the study period will be January 15, 2019 to December 15, 2020.

You may qualify if:

• 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.

You may not qualify if:

• For healthy newborns:
• Newborn with caesarean section; newborn with smoking mother; newborn with definite congenital heart disease before discharge.
• For major CHD newborns:

Sponsors & Collaborators

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

Study Sites (8)

People's Hospital of Golog Tibetan Autonomous Prefecture

Guoluo Prefecture, China

Location

Hainan women and children medical center

Haikou, China

Location

Yan'an Hospital Affiliated to Kunming Medical University

Kunming, China

Location

Tibet Autonomous People's Hospital

Lhasa, China

Location

People's Hospital of Luchun County, Yunnan Province

Luchun, China

Location

People's Hospital of Naqu District, Tibet

Naqu, China

Location

Qinghai Red Cross Hospital

Qinghai, China

Location

People's Hospital of Xinjiang Uygur Autonomous Region

Ürümqi, China

Location

Study Officials

• Weili Yan, PhD

  Epidemiology Office of Children's hospital of Fudan University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2019
• First Posted: January 23, 2020
• Study Start: February 1, 2020
• Primary Completion: April 15, 2021
• Study Completion: April 15, 2021
• Last Updated: July 28, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (8)