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Активно (без набиране) Фаза 1/2 NCT05280340

Anakinra for Preterm Infants Pilot

Фаза 1/2 – комбинирано ранно изпитване
Заболявания: Prematurity; Extreme Inflammation

Спонсор: Monash Medical Centre

Налично на: БГ
Обобщение
Phase I/II study of anakinra to prevent the impact of perinatal inflammation in extremely premature infants.
Описание
With improvements in antenatal and neonatal care over the last 20 years, now infants are born as early as 22 weeks gestation and survive to discharge from hospital. This increased survival comes with increased risk of long term issues such as cerebral palsy and chronic lung disease. There is strong evidence to show these risks are increased due to an underlying inflammatory process initiated around the time of premature birth. This study aims to prove the safety of treating infants born between 24-27+6 weeks gestation with Anakinra, a medication which is similar to an anti-inflammatory molecule the body makes itself called Interleukin 1 Receptor Antagonist (IL-1Ra). Anakinra acts to reduce the inflammatory response and is currently used in adults and children as young as 8 months to manage autoimmune inflammatory conditions. This study looks at the safety of giving Anakinra to babies born extremely premature, over the first 3 weeks of life. Once safety is established, the investigators will conduct a larger trial studying the efficacy of this treatment for reducing the risk of long-term complications caused by neonatal inflammation in extremely preterm infants.
Кой може да участва
Inclusion Criteria: * Born at 24 to 27+6 weeks gestation Exclusion Criteria: * Inability of the legal representatives to consent * Any disease or condition that the investigators judge could confound the trial results; these include, but are not limited to, genetic syndromes, severe cardiac abnormalities, substantial pre-/perinatal compromise (profound/severe hypoxia (SaO2 \<80% for \>3h), congenital diaphragmatic hernia, intrauterine stroke and others. * Imminent death
Места на провеждане 2
Австралия (1)
Monash Health
Clayton , Victoria
New Zealand (1)
Starship Children's Hospital, Te Whatu Ora - Health New Zealand
Grafton , Auckland
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 1/2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
24 Weeks
Максимална възраст
28 Weeks
Здрави доброволци
Не
Начална дата
15.02.2022
Крайна дата
01.03.2025
Регистрационен номер
NCT05280340
Източник
anzctr
Запитване за медицински туризъм

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