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Идёт набор NCT06768008

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

— Наблюдательное Congenital Heart Disease Coarctation of Aorta Aortic Stenosis Pulmonary Atresia

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Congenital Heart Disease, Coarctation of Aorta, Aortic Stenosis, Pulmonary Atresia. Базовые параметры: 1 Day — 28 Days · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Официальное название

Clinical Study of an Integrated Prenatal and Postnatal Treatment Model to Improve the Treatment Effect of Newborns With Critical Congenital Heart Disease

Обзор

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.

Первичные конечные точки

  • The rate of 30-day postoperative mortality [Срок оценки: Duration of hospital stay (an expected average of 30 day)]
Вторичные конечные точки (3)
  • The ratio of neonates received integrated prenatal and postnatal diagnose and treatment [Срок оценки: 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 [Срок оценки: Patient status before surgery at hospital]
  • The rate of Medium- and long-term survival rates, and re-operations [Срок оценки: During hospitalization (expected to average 1 week) and 5 years post-discharge]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • Biejing Anzhen Hospital — Пекин

Публикации

  • 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

Идентификаторы

NCT: NCT06768008 · ZD2024010

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗