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

Recruitingn/aAges 1 Day - 28 DaysAllBeijing Anzhen Hospital
NCT06768008 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 ulti

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📋 Eligibility rules (as published)
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.
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What it tests

  • Not listed
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Where

1 site
Biejing Anzhen Hospital
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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