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Идёт набор NCT06954142

Restricted Versus Liberal Fluid Intake for Prevention of Bronchopulmonary Dysplasia

Без фазы С лечением Bronchopulmonary Dysplasia

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: Fluid restriction, Liberal fluid intake.
Кому может быть актуально
Состояния в реестре: Bronchopulmonary Dysplasia. Базовые параметры: от 8 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
Швейцария
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Restricted Versus Liberal Fluid Intake for Prevention of Bronchopulmonary Dysplasia - RELIEF Trial. A Cluster-randomised Multiple Period Cross-over Trial.

Обзор

The aim of this study is to determine whether restricted fluid intake (135 ±5 mL/kg/day) compared to liberal fluid intake (165 ±5 mL/kg/day) from day 8 of life reduces the incidence of bronchopulmonary dysplasia (BPD) at 36 weeks postmenstrual age or prior death in preterm infants born \<30 weeks gestational age.

Подробное описание

Complications of preterm birth remain the leading cause of death in children under five years of age worldwide, accounting for approximately one million deaths annually. Among the survivors, bronchopulmonary dysplasia (BPD) is the most common severe complication. BPD is a chronic lung disease characterized by prolonged need for respiratory support and oxygen therapy, poor postnatal growth, and long-term impairments in lung function and neurodevelopment.

Despite advancements in neonatal care, BPD is the most common chronic lung disease in infancy and associated with increased mortality, repeated hospitalisation throughout childhood, impaired lung function up into adulthood, and long-term neurodevelopmental impairment. The incidence of BPD has remained stable over the past 15 years. This is likely due to the improved survival of extremely preterm infants, who are at the highest risk for BPD.

A key feature of evolving BPD is the accumulation of interstitial pulmonary edema, which reduces lung compliance and increases the need for respiratory support, thereby perpetuating a cycle of lung damage.

Currently, diuretics are sometimes used to manage pulmonary edema in preterm infants. While they can improve lung function in the short term, they come with potential risks including bone demineralization, nephrotoxicity, electrolyte imbalances, and impaired growth.

As a potentially safer alternative, fluid restriction is sometimes used to prevent or manage pulmonary edema. It is hypothesized to improve lung mechanics and reduce the need for respiratory support, without the adverse effects associated with medications. However, there is no robust evidence on optimal fluid targets in these patients.

SwissNeoNet, consisting of all nine Swiss NICUs, is a mandatory national registry, where data on all infants born before 32 weeks of gestation and/or with a birth weight \< 1501 g are collected. Fluid management practices vary among Swiss neonatal intensive care units (NICUs) following international guidelines recommending 135 to 180 mL/kg/day of fluids. This variation may contribute to the differing rates of BPD and mortality observed across centers, but fluid intake is not routinely captured in SwissNeoNet data, making it difficult to assess its impact.

In summary, although fluid restriction shows potential as a simple and low-risk intervention to reduce the incidence of BPD, current evidence is insufficient to support its routine use. There is a clear need for a robust, contemporary, and pragmatic trial to evaluate whether fluid restriction, started after the first week of life, can safely and effectively reduce the incidence of BPD or death in very preterm infants.

Вмешательства

  • Другое Fluid restriction
    Fluid restriction strategy (fluid target 135 ±5 mL/kg/d)
  • Другое Liberal fluid intake
    Liberal fluid intake strategy (fluid target 165 ± 5 mL/kg/d)

Первичные конечные точки

  • Bronchopulmonary dysplasia (BPD) [Срок оценки: From enrolment to 36 weeks postmenstrual age]
Вторичные конечные точки (11)
  • Complications of prematurity [Срок оценки: From enrolment to 36 weeks postmenstrual age]
  • Days to reach full feeds [Срок оценки: From enrolment to 36 weeks postmenstrual age]
  • Need of diuretics [Срок оценки: From enrolment to 36 weeks postmenstrual age]
  • Need of corticosteroids [Срок оценки: From enrolment to 36 weeks postmenstrual age]
  • Need of respiratory support [Срок оценки: At first discharge home, on average 37 weeks postmenstrual age]
  • Growth [Срок оценки: at birth and 36 weeks postmenstrual age]
  • Daily caloric intake [Срок оценки: From enrolment to 36 weeks postmenstrual age]
  • Dehydration [Срок оценки: From enrolment to 36 weeks postmenstrual age]
  • Fluid overload [Срок оценки: From enrolment to 36 weeks postmenstrual age]
  • Age at discharge [Срок оценки: At first discharge home, on average 37 weeks postmenstrual age]
  • Tube feeding [Срок оценки: At first discharge home, on average 37 weeks postmenstrual age]

Критерии участия

Критерии включения

  • Hospitalised preterm infants born before 30 weeks 0 days gestation
  • Signed informed consent for further research use of health-related data

Критерии исключения

  • congenital malformations
  • diseases likely to affect life expectancy, lung function, fluid strategy, or neurodevelopment
  • renal disease requiring fluid management outside the clinical standard of care
  • congenital heart disease not including patent ductus arteriosus (PDA)

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

Швейцария · 9 центров
  • Kantonsspital Aarau AG, Klinik für Kinder u. Jugendliche — Aarau
  • University Children's Hospital Basel (UKBB) — Basel
  • Inselspital Bern, Kinderklinik — Bern
  • Kantonsspital Graubünden, Departement Kinder- und Jugendmedizin — Chur
  • Hôpitaux universitaires de Genève (HUG), Unité de Néonatologie — Geneva
  • Centre hospitalier universitaire vaudois (CHUV) - Service de néonatologie — Lausanne
  • Luzerner Kantonsspital, Kinderspital — Lucerne
  • Ostschweizer Kinderspital & Neonatologie und Frauenklinik KSSG, Perinatalzentrum St. Galle — Sankt Gallen
  • … и ещё 1 центр

Идентификаторы

NCT: NCT06954142 · 2025-00321; ks22Schulzke

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗