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

NCT06768008 | Recruiting DMC

• 1 other identifier: ZD2024010
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patients with various congenital heart diseases.

You may qualify if:

• 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.

You may not qualify if:

• Only suitable for palliative surgery or single ventricle repair;
• Associated genetic/chromosomal abnormalities;
• Associated with other severe systemic diseases.

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead
• Capital Institute of Pediatrics, China: collaborator
• 307 Hospital of PLA: collaborator

Study Sites (1)

Biejing Anzhen Hospital

Beijing, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 41491678 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

myocardium, blood

MeSH Terms

Conditions

Heart Defects, Congenital; Aortic Coarctation; Aortic Valve Stenosis; Pulmonary Atresia; Pulmonary Valve Stenosis; Transposition of Great Vessels; Truncus Arteriosus, Persistent; Univentricular Heart; Tetralogy of Fallot; Hypoplastic Left Heart Syndrome; Scimitar Syndrome

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Vascular Malformations; Aortopulmonary Septal Defect; Heart Septal Defects; Lung Diseases; Respiratory Tract Diseases; Respiratory System Abnormalities; Vascular Diseases

Central Study Contacts

Lizhi Lv, MD

CONTACT

86+ 18800167531; prolvlizhi@126.com

Qiang Wang, MD

CONTACT

86+ 13691061902

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2024
• First Posted: January 10, 2025
• Study Start: January 1, 2022
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: January 10, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)