NCT06768008 An Integrated Prenatal and Postnatal Treatment Model for the Treatment of Newborns With Critical Congenital Heart Disease
| NCT ID | NCT06768008 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beijing Anzhen Hospital |
| Condition | Congenital Heart Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 10,000 participants |
| Start Date | 2022-01-01 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 10,000 participants in total. It began in 2022-01-01 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility Criteria
Inclusion Criteria: 1. Full-term infants (gestational age 37-40 weeks): age less than 28 days; 2. Preterm infants (gestational age greater than 32 weeks but less than 37 weeks): corrected gestational age as neonatal period, age less than 28 days; 3. Birth weight \> 1.5 kg; 4. Fetal diagnosis of congenital heart diseases by ultrasound at 22-26 weeks of gestation, suitable for biventricular repair. Exclusion Criteria: 1. Only suitable for palliative surgery or single ventricle repair; 2. Associated genetic/chromosomal abnormalities; 3. Associated with other severe systemic diseases.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06768008 clinical trial?
This trial is open to participants of all sexes, aged 1 Day or older, up to 28 Days, studying Congenital Heart Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06768008 currently recruiting?
Yes, NCT06768008 is actively recruiting participants. Contact the research team at prolvlizhi@126.com for enrollment information.
Where is the NCT06768008 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06768008 clinical trial?
NCT06768008 is sponsored by Beijing Anzhen Hospital. The trial plans to enroll 10,000 participants.