An observational study in Neonatal Congenital Heart Disease, sponsored by Children's Hospital of Fudan University. Not yet recruiting. Open to participants aged 6 Hours to 72 Hours, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Children's Hospital of Fudan University · Observational
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.
216 studies on the registry are indexed under Altitude Sickness; 46 are open to participants now.
This study's planned enrollment of 6,300 is above the median of 126 across 35 observational studies indexed under Altitude Sickness.
Browse Altitude Sickness studies →Children's Hospital of Fudan University is the lead sponsor of 268 studies on the registry; 95 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: 6 to 72 hours after birth
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.
Time frame: 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.
Time frame: 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.
Time frame: 6 to 72 hours after birth
No study locations are listed for this record.
Plan to share: 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.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Children's Hospital of Fudan University →