An Integrated Prenatal and Postnatal Treatment Model for the Treatment of Newborns With Critical Congenital Heart Disease

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

• Registration Number: NCT06768008
• Lead Sponsor: Beijing Anzhen Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-01
• Status Verified: 2024-09
• Study First Submitted: 2024-12-24
• Study First Submitted QC: 2025-01-05
• Last Update Submitted: 2025-01-05
• Study First Posted: 2025-01-10
• Last Update Posted: 2025-01-10
• Primary Completion: 2030-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The rate of 30-day postoperative mortality	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.

Secondary Outcome Measures

Name	Time	Method
The ratio of neonates received integrated prenatal and postnatal diagnose and treatment	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	Patient status before surgery at hospital
The rate of Medium- and long-term survival rates, and re-operations	During hospitalization (expected to average 1 week) and 5 years post-discharge	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.

Trial Locations

Locations (1)

Biejing Anzhen Hospital; 🇨🇳 Beijing, China