Congenital Heart DiseaseNCT06768008
An Integrated Prenatal and Postnatal Treatment Model for the Treatment of Newborns With Critical Congenital Heart Disease
An observational study of Congenital Heart Disease and Coarctation of Aorta, run by Beijing Anzhen Hospital at 1 site in China.
Trial summary
The purpose of this two-way cohort study was to explore whether an integrated prenatal and postnatal treatment model for neonates with critical congenital heart disease (CCHD) could be effective in avoiding preoperative morbidities, creating an ideal timing for surgery, thereby reducing postoperative in-hospital… Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Congenital Heart Disease, Coarctation of Aorta, Aortic Stenosis
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 31 Dec 2030
- 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 1 day to 28 days
- All sexes
- No healthy volunteers
- Child
Study population: Patients with various congenital heart diseases.
Who may be able to join
- Full-term infants (gestational age 37-40 weeks): age less than 28 days;
- Preterm infants (gestational age greater than 32 weeks but less than 37 weeks): corrected gestational age as neonatal period, age less than 28 days;
- Birth weight > 1.5 kg;
- Fetal diagnosis of congenital heart diseases by ultrasound at 22-26 weeks of gestation, suitable for biventricular repair.
Who cannot join
- Only suitable for palliative surgery or single ventricle repair;
- Associated genetic/chromosomal abnormalities;
- Associated with other severe systemic diseases.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Qiang Wang, MD contact
China1 site, 1 recruiting
- Recruiting
Biejing Anzhen Hospital
Beijing
Lizhi Lv, MD, 86+ 18800167531, prolvlizhi@126.com
Qiang Wang, MD
About this study
Official title: Clinical Study of an Integrated Prenatal and Postnatal Treatment Model to Improve the Treatment Effect of Newborns With Critical Congenital Heart Disease
The purpose of this two-way cohort study was to explore whether an integrated prenatal and postnatal treatment model for neonates with critical congenital heart disease (CCHD) could be effective in avoiding preoperative morbidities, creating an ideal timing for surgery, thereby reducing postoperative in-hospital mortality, and improving surgical prognosis compared with the traditional model of care. In addition, in neonates with CCHD associated with the right cardiac system, the investigators aim to further investigate whether early postnatal cardiac surgery has the potential advantage of obtaining a time window for myocardial regeneration and thus improving myocardial remodeling. The aim of this study is to improve the diagnostic and therapeutic capacity of critical congenital heart disease and to promote the integrated prenatal-postnatal treatment model for clinical use. This will ultimately improve the quality of healthcare services for patients with cardiovascular diseases and lay the foundation for exploring guidelines for the treatment of cardiovascular diseases suitable for China's national conditions.
The project will be jointly implemented by Beijing Anzhen Hospital , Capital Pediatric Research Institute, and 307 PLA General Hospital. Starting from January 1, 2022, the hospitals will continue to collect hospitalized cases of newborns with CCHD. The integrated prenatal and postnatal model is defined as a definitive diagnosis of CCHD in the fetal period (22-26 weeks), documentation of intrauterine transfer in our obstetrics department, subsequent initiation of an intrapartum or postpartum surgical plan after multidisciplinary consultation, and transfer to the pediatric heart center at the first hour of life, where the child is treated with either postpartum immediate or elective surgery, depending on patient status. For neonates who meet the indications for emergency surgery, surgery is performed immediately after birth. For neonates with non-emergency surgical indications, surgery is performed after birth adjustment to optimal status. The traditional model was defined as postpartum transfer via an outside hospital with routine interventions. The investigators then evaluate surgical prognosis and myocardial regenerative capacity to compare the effects of the two treatment models. This project will validate the advantages of an integrated prenatal and postnatal model over traditional models through real-world research and will improve prognosis in neonates with CCHD.
- Conditions
- Congenital Heart Disease, Coarctation of Aorta, Aortic Stenosis, Pulmonary Atresia, Pulmonary Stenosis, Transposition of the Great Arteries
- Keywords
- congenital heart disease, Integrated prenatal and postnatal model, neonate, surgery, Myocardium regeneration
- Medical subject headings
- Heart Defects, Congenital, Aortic Coarctation, Aortic Valve Stenosis, Pulmonary Atresia, Pulmonary Valve Stenosis, Transposition of Great Vessels, Truncus Arteriosus, Persistent, Univentricular Heart
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of 30-day postoperative mortality
The purpose of neonatal surgery is to address congenital malformations or other conditions that arise in newborns at birth. Although these surgeries are generally considered safe, there is still a risk of death within 30 days of surgery. Close monitoring and prompt intervention are essential to minimize this risk and ensure the best possible outcome for neonatal patients.
Measured: Duration of hospital stay (an expected average of 30 day)
Secondary outcomes (3)
The ratio of neonates received integrated prenatal and postnatal diagnose and treatment
Measured: Duration of hospital stay (an expected average of 1 week) and 5 years after discharge]
The incidence of heart failure, metabolic acidosis, severe cyanosis before surgery
Measured: Patient status before surgery at hospital
The rate of Medium- and long-term survival rates, and re-operations
The rate of medium- and long-term survival, as well as the frequency of re-operations, are crucial indicators of the success of surgical interventions. Medium-term survival typically refers to patient outcomes over several months to a few years, while long-term survival indicates the patient's prognosis over many years following surgery. Re-operations may be required due to complications, recurrence of the underlying condition, or failure of the initial surgical procedure. Evaluating these factors helps in assessing the effectiveness of surgical techniques, the quality of patient care, and the need for potential improvements in treatment strategies.
Measured: During hospitalization (expected to average 1 week) and 5 years post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start1 Jan 2022
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Beijing Anzhen HospitalThe 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
- Other
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Capital Institute of Pediatrics, China, 307 Hospital of PLA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06768008
- Sponsor's protocol ID
- ZD2024010
- Status last verified
- Sep 2024
- First submitted
- 24 Dec 2024
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- Individual data sharing
- No
Publications
Sun Y, Han Y, Li G, Wu Y, Yan J, Wang Q. Prenatal-postnatal integrated management model improves outcomes of neonatal cardiac surgery in critical congenital heart disease: a retrospective cohort study. BMC Pediatr. 2026 Jan 5;26(1):6. doi: 10.1186/s12887-025-06378-x.
PubMed 41491678
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of an Integrated Prenatal and Postnatal Treatment Model to Improve the Treatment Effect of Newborns With Critical Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT06768008
- Acronym / sponsor ID
- ZD2024010
- Conditions
- Congenital Heart Disease, Coarctation of Aorta, Aortic Stenosis, Pulmonary Atresia, Pulmonary Stenosis, Transposition of the Great Arteries
- Keywords
- congenital heart disease, Integrated prenatal and postnatal model, neonate, surgery, Myocardium regeneration
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Collaborators
- Capital Institute of Pediatrics, China, 307 Hospital of PLA
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 10 Jan 2025 (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.
The purpose of this two-way cohort study was to explore whether an integrated prenatal and postnatal treatment model for neonates with critical congenital heart disease (CCHD) could be effective in avoiding preoperative morbidities, creating an ideal timing for surgery, thereby reducing postoperative in-hospital mortality, and improving surgical prognosis compared with the traditional model of care. In addition, in neonates with CCHD associated with the right cardiac system, the investigators aim to further investigate whether early postnatal cardiac surgery has the potential advantage of obtaining a time window for myocardial regeneration and thus improving myocardial remodeling. The aim of this study is to improve the diagnostic and therapeutic capacity of critical congenital heart disease and to promote the integrated prenatal-postnatal treatment model for clinical use. This will ultimately improve the quality of healthcare services for patients with cardiovascular diseases and lay the foundation for exploring guidelines for the treatment of cardiovascular diseases suitable for China's national conditions.
The project will be jointly implemented by Beijing Anzhen Hospital , Capital Pediatric Research Institute, and 307 PLA General Hospital. Starting from January 1, 2022, the hospitals will continue to collect hospitalized cases of newborns with CCHD. The integrated prenatal and postnatal model is defined as a definitive diagnosis of CCHD in the fetal period (22-26 weeks), documentation of intrauterine transfer in our obstetrics department, subsequent initiation of an intrapartum or postpartum surgical plan after multidisciplinary consultation, and transfer to the pediatric heart center at the first hour of life, where the child is treated with either postpartum immediate or elective surgery, depending on patient status. For neonates who meet the indications for emergency surgery, surgery is performed immediately after birth. For neonates with non-emergency surgical indications, surgery is performed after birth adjustment to optimal status. The traditional model was defined as postpartum transfer via an outside hospital with routine interventions. The investigators then evaluate surgical prognosis and myocardial regenerative capacity to compare the effects of the two treatment models. This project will validate the advantages of an integrated prenatal and postnatal model over traditional models through real-world research and will improve prognosis in neonates with CCHD.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients with various congenital heart diseases.
Key inclusion criteria (4 listed)
- Full-term infants (gestational age 37-40 weeks): age less than 28 days;
- Preterm infants (gestational age greater than 32 weeks but less than 37 weeks): corrected gestational age as neonatal period, age less than 28 days;
- Birth weight > 1.5 kg;
- Fetal diagnosis of congenital heart diseases by ultrasound at 22-26 weeks of gestation, suitable for biventricular repair.
Key exclusion criteria (3 listed)
- Only suitable for palliative surgery or single ventricle repair;
- Associated genetic/chromosomal abnormalities;
- Associated with other severe systemic diseases.
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
The rate of 30-day postoperative mortality
Time frame: Duration of hospital stay (an expected average of 30 day)
The purpose of neonatal surgery is to address congenital malformations or other conditions that arise in newborns at birth. Although these surgeries are generally considered safe, there is still a risk of death within 30 days of surgery. Close monitoring and prompt intervention are essential to minimize this risk and ensure the best possible outcome for neonatal patients.
3 secondary outcomes
The ratio of neonates received integrated prenatal and postnatal diagnose and treatment
Time frame: Duration of hospital stay (an expected average of 1 week) and 5 years after discharge]
The incidence of heart failure, metabolic acidosis, severe cyanosis before surgery
Time frame: Patient status before surgery at hospital
The rate of Medium- and long-term survival rates, and re-operations
Time frame: During hospitalization (expected to average 1 week) and 5 years post-discharge
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 10 Jan 2025.
- Derived from this study: PubMed 41491678Sun Y, Han Y, Li G, Wu Y, Yan J, Wang Q. Prenatal-postnatal integrated management model improves outcomes of neonatal cardiac surgery in critical congenital heart disease: a retrospective cohort study. BMC Pediatr. 2026 Jan 5;26(1):6. doi: 10.1186/s12887-025-06378-x.
- Individual participant dataSharing planned: No
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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.
Qiang Wang, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease and Coarctation of Aorta, run by Beijing Anzhen Hospital at 1 site in China.
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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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 Lizhi Lv, MD (86+ 18800167531, prolvlizhi@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of 30-day postoperative mortality (time frame: Duration of hospital stay (an expected average of 30 day)). 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 NCT06768008, which also lists 1 linked publication.
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 10 Jan 2025.