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

Launched by BEIJING ANZHEN HOSPITAL · Jan 5, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new approach to treat newborns with serious heart conditions known as critical congenital heart disease (CCHD). The goal is to find out if a combined prenatal and postnatal treatment plan can lead to better health outcomes compared to the traditional method. In this new model, doctors aim to identify heart problems before birth (between 22-26 weeks of pregnancy) and plan for immediate care right after the baby is born. This approach hopes to reduce complications before surgery, find the best timing for operations, and ultimately improve survival rates and heart health for these babies.

To be eligible for the trial, infants must be full-term or late preterm (born between 32 to 40 weeks of pregnancy) and weigh more than 1.5 kg. They also need to have been diagnosed with specific heart conditions during pregnancy. Participants can expect to receive specialized care tailored to their needs, with immediate surgery if necessary, or carefully planned surgery based on their health after birth. This trial is being conducted at several hospitals in Beijing and aims to enhance treatment guidelines for heart conditions in newborns, ensuring they receive the best possible care.

Gender

ALL

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.