Clinical trial NCT06768008: An Integrated Prenatal and Postnatal Treatment Model for the Treatment of Newborns With Critical Congenital Heart Disease
Official title: Clinical Study of an Integrated Prenatal and Postnatal Treatment Model to Improve the Treatment Effect of Newborns With Critical Congenital Heart Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Congenital Heart Disease
Coarctation of Aorta
Aortic Stenosis
Pulmonary Atresia
Pulmonary Stenosis
Transposition of the Great Arteries
Truncus Arteriosus
Single Ventricle
Tetralogy of Fallot (TOF)
Interrupted Aortic Arch
Hypoplastic Left Heart Syndrome (HLHS)
Total Anomalous Pulmonary Venous Connection
Keywords: congenital heart disease
Integrated prenatal and postnatal model
neonate
surgery
Myocardium regeneration
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
Collaborators: name: Capital Institute of Pediatrics, China
name: 307 Hospital of PLA
First posted: 2025-01-10
Enrollment: 10000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with various congenital heart diseases.

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.

Primary outcomes:
measure: The rate of 30-day postoperative mortality
timeFrame: Duration of hospital stay (an expected average of 30 day)
Secondary outcomes:
measure: The ratio of neonates received integrated prenatal and postnatal diagnose and treatment
timeFrame: Duration of hospital stay (an expected average of 1 week) and 5 years after discharge]
measure: The incidence of heart failure, metabolic acidosis, severe cyanosis before surgery
timeFrame: Patient status before surgery at hospital
measure: The rate of Medium- and long-term survival rates, and re-operations
timeFrame: During hospitalization (expected to average 1 week) and 5 years post-discharge
Other outcomes:
Locations:
city: Beijing
country: China
facility: Biejing Anzhen Hospital
Study officials:
References: