Neonatal Congenital Heart DiseaseNCT07901998
Optimization of Two-Indicator Screening Protocol for Neonatal Congenital Heart Disease at High Altitude
An observational study of Neonatal Congenital Heart Disease, run by Children's Hospital of Fudan University.
Trial summary
This is a prospective observational screening study. First, researchers will optimize a two-indicator screening protocol for neonatal congenital heart disease (NCHD) adapted to high-altitude regions and evaluate its screening accuracy. Read more about this study
- Who is it for?
- Ages 6 to 72 hoursHealthy volunteers can take part
- Conditions the study is for
- Neonatal Congenital Heart Disease
- How many people
- 6,300 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 6 to 72 hours
- All sexes
- Healthy volunteers accepted
- Child
Study population: Live-born newborns delivered consecutively at collaborative high-altitude hospitals . Eligible infants are aged 6-72 hours after birth, with stable vital signs. Mothers have resided in the high-altitude region for at least 6 months during pregnancy. Guardians provide written informed consent.
Who may be able to join
- Live-born newborns delivered consecutively at the collaborative hospitals
- Postnatal age between 6 hours and 72 hours
- Stable respiration, ruddy complexion and normal muscle tone
- The newborn's mother has resided in the corresponding high-altitude area for at least 6 months during pregnancy
- The newborn's legal guardians are fully informed, voluntarily participate and sign written informed consent
Who cannot join
- Prenatally diagnosed congenital heart disease
- Confirmed congenital heart disease by echocardiography performed after birth for any reason
- Critical conditions that affect blood oxygen saturation, including severe respiratory disease, severe infection, severe asphyxia
- Newborns receiving oxygen therapy or mechanical ventilation
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Optimization of Two-Indicator Screening Protocol for Neonatal Congenital Heart Disease in High-Altitude Regions
This is a prospective observational screening study. First, researchers will optimize a two-indicator screening protocol for neonatal congenital heart disease (NCHD) adapted to high-altitude regions and evaluate its screening accuracy. Second, researchers will compare the screening performance between the intelligent screening device and the optimized conventional manual screening, to preliminarily explore the value of this intelligent screening tool at high altitude. Finally, researchers will use descriptive qualitative research to deeply understand nurses' real-world experience, operational barriers and training needs when using the plainland two-indicator protocol, the optimized high-altitude two-indicator protocol, and the intelligent screening device in high-altitude settings. Echocardiography will be used as the reference gold standard.
- Conditions
- Neonatal Congenital Heart Disease
- Keywords
- high altitude, congenital heart disease, newborn screening
- Medical subject headings
- Altitude Sickness, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| High-altitude newborn cohort | Newborn infants born in high-altitude regions. All participants receive routine congenital heart disease screening. Clinical data and screening results are collected for observational analysis. No experimental intervention is applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of the optimized dual-indicator neonatal congenital heart disease screening protocol
Sensitivity and specificity of the high-altitude optimized dual-indicator screening protocol for neonatal congenital heart disease, with echocardiography as the reference gold standard.
Measured: 6 to 72 hours after birth
Secondary outcomes (3)
False positive rate of the optimized dual-indicator screening protocol
False positive rate of the high-altitude optimized dual-indicator screening protocol for neonatal congenital heart disease, confirmed by echocardiography as gold standard.
Measured: 6 to 72 hours after birth
Positive predictive value (PPV) of the optimized dual-indicator screening protocol
Positive predictive value of the high-altitude optimized dual-indicator screening protocol for neonatal congenital heart disease, confirmed by echocardiography.
Measured: 6 to 72 hours after birth
Sensitivity and specificity of the intelligent screening device
Sensitivity and specificity of the intelligent screening device for neonatal congenital heart disease screening in high-altitude regions, with echocardiography as reference standard.
Measured: 6 to 72 hours after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 6,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Qinghai Red Cross Hospital, Yan'an Affiliated Hospital of Kunming Medical University
- Responsible party
- Sponsor
- Investigators
- xiaojing Hu, PhD, Principal investigator, Children's Hospital of Fudan University, Shanghai, 200032
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07901998
- Sponsor's protocol ID
- FDCH-CHD-2026-10-12
- Other IDs
- 2021YFC2701000, 23DZ2203000，24DZ2202800, XZ202401ZY0042, GWJJZX20251001068, 2024GZL-ZD04, 2024D029
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Researchers have not yet determined the plan for sharing individual participant data. The decision will be made after study completion, considering participant privacy protection, ethical requirements, and relevant institutional regulations.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Two-Indicator Screening Protocol for Neonatal Congenital Heart Disease in High-Altitude Regions
- ClinicalTrials.gov ID
- NCT07901998
- Acronym / sponsor ID
- FDCH-CHD-2026-10-12
- Conditions
- Neonatal Congenital Heart Disease
- Keywords
- high altitude, congenital heart disease, newborn screening
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 6,300 participants (estimated)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Collaborators
- Qinghai Red Cross Hospital, Yan'an Affiliated Hospital of Kunming Medical University
- Study start
- Oct 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 28 Oct 2026 (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.
This is a prospective observational screening study. First, researchers will optimize a two-indicator screening protocol for neonatal congenital heart disease (NCHD) adapted to high-altitude regions and evaluate its screening accuracy. Second, researchers will compare the screening performance between the intelligent screening device and the optimized conventional manual screening, to preliminarily explore the value of this intelligent screening tool at high altitude. Finally, researchers will use descriptive qualitative research to deeply understand nurses' real-world experience, operational barriers and training needs when using the plainland two-indicator protocol, the optimized high-altitude two-indicator protocol, and the intelligent screening device in high-altitude settings. Echocardiography will be used as the reference gold standard.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High-altitude newborn cohort | – | –Newborn infants born in high-altitude regions. All participants receive routine congenital heart disease screening. Clinical data and screening results are collected for observational analysis. No experimental intervention is applied. |
Who may qualify
- Ages
- 6 to 72 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Live-born newborns delivered consecutively at collaborative high-altitude hospitals . Eligible infants are aged 6-72 hours after birth, with stable vital signs. Mothers have resided in the high-altitude region for at least 6 months during pregnancy. Guardians provide written informed consent.
Key inclusion criteria (5 listed)
- Live-born newborns delivered consecutively at the collaborative hospitals
- Postnatal age between 6 hours and 72 hours
- Stable respiration, ruddy complexion and normal muscle tone
- The newborn's mother has resided in the corresponding high-altitude area for at least 6 months during pregnancy
- The newborn's legal guardians are fully informed, voluntarily participate and sign written informed consent
Key exclusion criteria (4 listed)
- Prenatally diagnosed congenital heart disease
- Confirmed congenital heart disease by echocardiography performed after birth for any reason
- Critical conditions that affect blood oxygen saturation, including severe respiratory disease, severe infection, severe asphyxia
- Newborns receiving oxygen therapy or mechanical ventilation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity and specificity of the optimized dual-indicator neonatal congenital heart disease screening protocol
Time frame: 6 to 72 hours after birth
Sensitivity and specificity of the high-altitude optimized dual-indicator screening protocol for neonatal congenital heart disease, with echocardiography as the reference gold standard.
3 secondary outcomes
False positive rate of the optimized dual-indicator screening protocol
Time frame: 6 to 72 hours after birth
Positive predictive value (PPV) of the optimized dual-indicator screening protocol
Time frame: 6 to 72 hours after birth
Sensitivity and specificity of the intelligent screening device
Time frame: 6 to 72 hours after birth
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: Undecided. Researchers have not yet determined the plan for sharing individual participant data. The decision will be made after study completion, considering participant privacy protection, ethical requirements, and relevant institutional regulations.
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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.
xiaojing Hu, PhD principal investigator
Children's Hospital of Fudan University, Shanghai, 200032
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Congenital Heart Disease, run by Children's Hospital of Fudan University.
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 5 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: opening soon, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact lifeng Yang, Phd candidate (15209365882, 174607369@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of the optimized dual-indicator neonatal congenital heart disease screening protocol (time frame: 6 to 72 hours after birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Oct 2026.