Dexamethasone Regimens for BPD Prevention in Preterm Infants
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
- В протоколе указаны: Dexamethasone. Dart, Dexametasone. Medium.
- Кому может быть актуально
- Состояния в реестре: Infant, Premature, Bronchopulmonary Dysplasia (BPD). Базовые параметры: 14 Days — 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
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
The Outcomes of Different Dexamethasone Regimens for the Prevention of Bronchopulmonary Dysplasia in Preterm Infants: A Multicenter Randomized Controlled Trial
Обзор
The goal of this clinical trial is to compare the effectiveness of two different dexamethasone treatment regimens (the DART regimen and the medium-dose tapering regimen) in reducing the incidence of Bronchopulmonary Dysplasia (BPD) or death by 36 weeks of postmenstrual age in premature infants. This study will also assess the safety of these treatments. The main questions it aims to answer are: Does the DART regimen, compared to the medium-dose tapering regimen, lower the rate of BPD or BPD-related death by 36 weeks of postmenstrual age in eligible premature infants? How do the two regimens compare in terms of short-term respiratory outcomes (like time to come off the ventilator), complications at hospital discharge, and long-term neurodevelopmental outcomes at 18-24 months of corrected age? Researchers will compare the DART regimen group (lower cumulative dose, given over 10 days) to the medium-dose tapering regimen group (higher cumulative dose, given over 7 days) to see which one is more effective and safer. Participants will: Inclusion Criteria (Must meet ALL of the following) 1. Gestational age 24+0 to 29+6 weeks; requires invasive mechanical ventilation for ≥14 days after birth; within 14-28 days of age at first receive of dexamethasone. 2. FiO₂ \> 40% and MAP \> 8 cmH₂O (maintained for at least 24 hours prior to enrollment). 3. Parent/Legal guardian has provided signed informed consent. 4. No use of other steroid medications prior to enrollment, as explicitly stated in the inclusion criteria. 2\. Exclusion Criteria (Will be excluded if they meet ANY of the following) 1. Presence of ventilator-associated pneumonia at the time of enrollment. 2. Severe congenital malformations (e.g., severe cardiac anomalies, congenital diaphragmatic hernia, etc.), or known immunodeficiency. 3. Suffering from other severe life-threatening illnesses with a short-expected survival time. 4. Parent/Legal guardian refuses to participate in the study.
Подробное описание
This study is a multicenter, prospective, randomized, parallel-controlled clinical trial.
Study Sites: Multiple hospitals across China with high-level Neonatal Intensive Care Units (NICUs) will participate.
Randomization:
A randomization method will be used to assign participants to one of two study groups in a 1:1 ratio. Subjects will receive a unique randomization number in the order of enrollment and will be assigned to one of the following treatment groups:
* DART regimen * Moderate-dose tapering regimen
Blinding:
Blinding will be applied for the assessment of secondary outcomes (e.g., neurodevelopmental outcomes). Evaluators will be from an independent team and will not be involved in the routine clinical care of the infants.
1. DART Regimen Group
Cumulative dose: 0.89 mg/kg over 10 days Intravenous dexamethasone \[17\], administered as follows: * 0.075 mg/kg/dose, every 12 hours for 3 days * 0.05 mg/kg/dose, every 12 hours for 3 days * 0.025 mg/kg/dose, every 12 hours for 2 days * 0.01 mg/kg/dose, every 12 hours for 2 days, then discontinue
If extubation is not successful more than or equal to two weeks after completing the treatment (FiO2 \> 40% and MAP \> 8 cmH2O), the DART regimen may be repeated. The number of repeated courses, reasons, and specific timing must be documented.
(Note: According to reference \[13\], if the infant meets respiratory criteria again at least 72 hours after completing the initial 9-day course, a second 9-day course may be administered. If the infant meets the criteria again during the 42-day observation period, a third course may be considered.)
Rationale for design:
Due to the rapid physiological changes in preterm infants, early responses to interventions are often evident within short timeframes. The shorter assessment intervals aim to capture early treatment effects more sensitively and dynamically.
Previous exploratory observations indicated that two-week intervals are feasible and safe for evaluating parameters such as weight gain and lab changes, with no significant adverse effects observed. 2. Moderate-Dose Tapering Regimen Group
Cumulative dose: 2.35 mg/kg over 7 days Intravenous dexamethasone \[19\], administered as follows:
* 0.5 mg/kg/d for 3 days * 0.25 mg/kg/d for 3 days * 0.1 mg/kg/d for 1 day
If extubation is not successful more than or equal to two weeks after completing the treatment (FiO2 \> 40% and MAP \> 8 cmH2O), the same regimen may be repeated. The number of repeated courses, reasons, and specific timing must be documented.
Definition of BPD Severity (based on 2019 consensus criteria):
Clinically, BPD is defined as oxygen and/or respiratory support dependency for at least 28 days or continuing until 36 weeks corrected gestational age in preterm infants born at \<32 weeks gestation.
Вмешательства
- Препарат Dexamethasone. Dart
DART regimen group (cumulative dose 0.89 mg/kg over 10 days): intravenous dexamethasone administered as follows: 0.075 mg/kg/dose every 12 hours for 3 days 0.05 mg/kg/dose every 12 hours for 3 days 0.025 mg/kg/dose every 12 hours for 2 days 0.01 mg/kg/dose every 12 hours for 2 days, then discontinue. If extubation is not successful more than or equal to 2 weeks after completing the treatment, the regimen may be repeated. - Препарат Dexametasone. Medium
Medium-dose tapering regimen group (cumulative dose 2.35 mg/kg over 7 days): intravenous dexamethasone administered as follows: 0.5 mg/kg/d for 3 days 0.25 mg/kg/d for 3 days 0.1 mg/kg/d for 1 day If extubation is not successful more than or equal to 2 weeks after completing the treatment, the regimen may be repeated.
Первичные конечные точки
- Incidence of Bronchopulmonary dysplasia (BPD) and/or death at 36 weeks corrected age [Срок оценки: 36 weeks PMA]
Вторичные конечные точки (10)
- Extubation Rate (72 hours) [Срок оценки: 72 hours]
- Extubation Rate (7 days) [Срок оценки: 7 days]
- Incidence of Adverse Events Including Intestinal Perforation, Hyperglycemia, Hypertension, Infection, and Gastrointestinal Bleeding Following Dexamethasone Administration [Срок оценки: Within 72 hours and 7 days after dexamethasone administration]
- Oxygenation index [Срок оценки: Baseline (Day 0) and on Days 3, 7, 10, 14, 28 Following Dexamethasone Therapy]
- Total Duration of Invasive Mechanical Ventilation During Initial Hospitalization [Срок оценки: From birth until hospital discharge (up to approximately 44 weeks postmenstrual age)]
- Total Length of Initial Hospitalization (Days from Birth to Discharge) [Срок оценки: From birth until hospital discharge (up to approximately 44 weeks postmenstrual age )]
- Incidence of Neonatal Complications Including ROP, IVH, Hemodynamically Significant PDA, Late-Onset Sepsis, PVL, NEC, SIP, Short Bowel Syndrome, and Pulmonary Hypertension [Срок оценки: From birth until hospital discharge (up to approximately 44 weeks postmenstrual age)]
- Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III) - Cognitive Composite Score (MDI) [Срок оценки: At 18 to 24 months corrected age]
- Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III) - Motor Composite Score (PDI) [Срок оценки: At 18 to 24 months corrected age]
- Griffiths Mental Development Scales - General Development Score [Срок оценки: At 18 to 24 months corrected age]
Критерии участия
Inclusion Criteria (Must meet ALL of the following)
- Gestational age 24+0 to 29+6 weeks; requires invasive mechanical ventilation for ≥14 days after birth; within 14-28 days of age at first receive of dexamethasone.
- FiO₂ > 40% and MAP > 8 cmH₂O (maintained for at least 24 hours prior to enrollment).
- Parent/Legal guardian has provided signed informed consent.
- No use of other steroid medications prior to enrollment, as explicitly stated in the inclusion criteria.
Exclusion Criteria (Will be excluded if they meet ANY of the following)
- Presence of ventilator-associated pneumonia at the time of enrollment.
- Severe congenital malformations (e.g., severe cardiac anomalies, congenital diaphragmatic hernia, etc.), or known immunodeficiency.
- Suffering from other severe life-threatening illnesses with a short-expected survival time.
- Parent/Legal guardian refuses to participate in the study.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Профилактика
Центры проведения
Китай · 24 центра
- Children's Hospital, Zhejiang University School of Medicine — Ханчжоу
- Chengdu Maternal and Children's Health Care Hospital — Чэнду
- Children's Hospital of Chongqing Medical University — Чунцин
- Women and Children's Hospital of Chongqing Medical University — Чунцин
- Guangdong Women and Children Hospital — Guangdong
- Guangxi Maternal and Child Health Hospital — Guangxi
- Guiyang Maternity and Child Health Care Hospital — Guiyang
- Guizhou Provincial People's Hospital — Guizhou
- … и ещё 16 центров
Идентификаторы
NCT: NCT07052201 · 2025-IRB-0185-P-02