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

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.

Study Overview

• Status: Recruiting
• Conditions: Aortic Stenosis; Congenital Heart Disease; Transposition of the Great Arteries; Coarctation of Aorta; Interrupted Aortic Arch; Pulmonary Atresia; Single Ventricle; Pulmonary Stenosis; Hypoplastic Left Heart Syndrome (HLHS); Tetralogy of Fallot (TOF); Truncus Arteriosus; Total Anomalous Pulmonary Venous Connection

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

• Study Contact: Name: Lizhi Lv, MD; Phone Number: 86+ 18800167531; Email: prolvlizhi@126.com
• Study Contact Backup: Name: Qiang Wang, MD; Phone Number: 86+ 13691061902

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Biejing Anzhen Hospital
    • Contact: Qiang Wang, MD
    • Contact: Lizhi Lv, MD; Phone Number: 86+ 18800167531; Email: prolvlizhi@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with various congenital heart diseases.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Duration of hospital stay (an expected average of 30 day)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	During hospitalization (expected to average 1 week) and 5 years post-discharge

Collaborators and Investigators

• Sponsor: Beijing Anzhen Hospital
• Collaborators: 307 Hospital of PLA; Capital Institute of Pediatrics, China

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: December 24, 2024
• First Submitted That Met QC Criteria: January 5, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 5, 2025
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: surgery; neonate; congenital heart disease; Integrated prenatal and postnatal model; Myocardium regeneration
• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Pathological Conditions, Anatomical; Heart Valve Diseases; Ventricular Outflow Obstruction; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Septal Defects; Vascular Malformations; Aortopulmonary Septal Defect; Univentricular Heart; Aortic Valve Stenosis; Constriction, Pathologic; Heart Diseases; Heart Defects, Congenital; Tetralogy of Fallot; Pulmonary Valve Stenosis; Transposition of Great Vessels; Pulmonary Atresia; Truncus Arteriosus, Persistent; Hypoplastic Left Heart Syndrome; Aortic Coarctation
• Other Study ID Numbers: ZD2024010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No