POX Range of Healthy Newborns at Different AltitudesNCT04238104

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

An observational study of POX Range of Healthy Newborns at Different Altitudes and POX Threshold for Screening Major CHD in Neonates, run by Children's Hospital of Fudan University at 8 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages Up to 28 days
Conditions the study is for: POX Range of Healthy Newborns at Different Altitudes, POX Threshold for Screening Major CHD in Neonates
How many people: 2,200 participants
Where: 8 sitesChina
Study dates: 1 Feb 2020to 15 Apr 2021
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Up to 28 days
All sexes
No healthy volunteers
Child

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.

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

China8 sites

People's Hospital of Golog Tibetan Autonomous Prefecture
Guoluo Prefecture
Hainan women and children medical center
Haikou
Yan'an Hospital Affiliated to Kunming Medical University
Kunming
Tibet Autonomous People's Hospital
Lhasa
People's Hospital of Luchun County, Yunnan Province
Luchun
People's Hospital of Naqu District, Tibet
Naqu
Qinghai Red Cross Hospital
Qinghai
People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi

Other trials in China

About this study

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

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.

Read the detailed 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.

Conditions: POX Range of Healthy Newborns at Different Altitudes, POX Threshold for Screening Major CHD in Neonates
Being tested: no intervention
Keywords: Saturation, Cut-off value, Neonates, Altitude, POX, major CHD

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

no interventionOther
it's only observational study. No interventions.

Study groups in NCT04238104
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: no intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: At 6th hours after birth

Secondary outcomes (9)

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.
Measured: At 12th hours after birth
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.
Measured: At 24th hours after birth
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.
Measured: At 48th hours after birth
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.
Measured: At 72th hours after birth
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.
Measured: At 6th hours after birth
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.
Measured: At 12th hours after birth
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.
Measured: At 24th hours after birth
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.
Measured: At 48th hours after birth
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.
Measured: At 72th hours after birth

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 202015 Apr 2021

First posted23 Jan 2020
Study start1 Feb 2020
Primary completion15 Apr 2021
Study completion15 Apr 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for POX Range of Healthy Newborns at Different AltitudesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Cross-sectional
Enrolment: 2,200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04238104
Sponsor's protocol ID: 2019-296
Status last verified: Dec 2020
First submitted: 26 Nov 2019
Last updated: 28 Jul 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04238104
Acronym / sponsor ID: 2019-296
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
Study type: Observational
Recruitment status: Completed
Enrolment: 2,200 participants (actual)
Lead sponsor: Children's Hospital of Fudan UniversityUniversity, hospital or other
Collaborators: Hainan women and children medical center, People's Hospital of Xinjiang Uygur Autonomous Region, Yan'an Affiliated Hospital of Kunming Medical University, Qinghai Red Cross Hospital, Tibet Autonomous Region People's Hospital, People's Hospital of Golog Tibetan Autonomous Prefecture, People's Hospital of Naqu District, Tibet, People's Hospital of Luchun County, Yunnan Province
Study start: 1 Feb 2020 (actual)
Primary completion: 15 Apr 2021 (actual)
Study completion: 15 Apr 2021 (actual)
First posted: 23 Jan 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Cross-sectional
Number of arms: 6

Arm	Type	Receives
sea level	–	Other: no interventionPulse 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.
altitude <1000	–	Other: no interventionPulse 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.
altitude 1000-2000	–	Other: no interventionPulse 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.
altitude 2000-3000	–	Other: no interventionPulse 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.
altitude 3000-4000	–	Other: no interventionPulse 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.
altitude 4000-5000	–	Other: no interventionPulse 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.

Who may qualify

Ages: Up to 28 days
Sex: All
Healthy volunteers: Not accepted
Age groups: Child
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.

Key inclusion criteria (7 listed)

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).
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.

Key exclusion criteria (4 listed)

Newborn with caesarean section; newborn with smoking mother; newborn with definite congenital heart disease before discharge.
There is no exclusion criteria for major CHD.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
no interventionit's only observational study. No interventions.	Other	altitude 1000-2000, altitude 2000-3000, altitude 3000-4000, altitude 4000-5000, altitude <1000, sea level

Primary outcome

Pulse oximetry of healthy newborns at 6th hour after birth at different altitudes
Time frame: At 6th hours after birth
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.

9 secondary outcomes

Pulse oximetry of healthy newborns at 12th hour after birth at different altitudes
Time frame: At 12th hours after birth
Pulse oximetry of healthy newborns at 24th hour after birth at different altitudes
Time frame: At 24th hours after birth
Pulse oximetry of healthy newborns at 48th hour after birth at different altitudes
Time frame: At 48th hours after birth
Pulse oximetry of healthy newborns at 72th hour after birth at different altitudes
Time frame: At 72th hours after birth
Pulse oximetry of newborns with critical congenital heart disease at 6th hour after birth at different altitudes
Time frame: At 6th hours after birth
Pulse oximetry of newborns with critical congenital heart disease at 12th hour after birth at different altitudes
Time frame: At 12th hours after birth
Pulse oximetry of newborns with critical congenital heart disease at 24th hour after birth at different altitudes
Time frame: At 24th hours after birth
Pulse oximetry of newborns with critical congenital heart disease at 48th hour after birth at different altitudes
Time frame: At 48th hours after birth
Pulse oximetry of newborns with critical congenital heart disease at 72th hour after birth at different altitudes
Time frame: At 72th hours after birth

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Weili Yan, PhD study chair

Epidemiology Office of Children's hospital of Fudan University

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pulse oximetry of healthy newborns at 6th hour after birth at different altitudes (time frame: At 6th hours after birth). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04238104.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2021.