Multi-Center Clinical Database of Infants for the Investigation of Early Nutrition Biomarkers
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: Infant Development. Базовые параметры: 0 Days — 5 лет · 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
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
An observational study to generate a long-term outcome database from medical records for infants who completed protocol SS-101-18 or infants who are breastfed, fed commercial formula, or fed a marketed ByHeart formula.
Подробное описание
The first Cohort (Cohort 1) goals of the registry include: to compile a clinical database of children who were fed in SS-101-18 by breastfeeding, commercial formula, or ByHeart formula; to investigate any difference in demographics, growth, development, medical diagnoses, and outcomes between the feeding groups, and in particular to compare ByHeart formula-fed infants against commercial formula-fed infants, and referenced against breastfed infants.
The second Cohort (Cohort 2) goals of the registry include: to compile a clinical database of children who were fed by breastfeeding or commercial formula (including ByHeart formula); to describe any difference in growth, development, medical diagnoses, and outcomes based on early nutritional intake; and to inform or facilitate development of future ByHeart products.
Первичные конечные точки
- Cohort 1: Growth, Development, Diagnoses, and Long-term Outcomes [Срок оценки: 5 years]
- Cohort 2: Growth, Development, Diagnoses, and Long-term Outcomes [Срок оценки: 5 years]
Критерии участия
Inclusion Criteria Cohort 1:
- Active participation in SS-101-18 through Visit 9
- Provision of signed and dated informed consent form (ICF) by parent or legally authorized representative (LAR)
- Stated willingness to comply with all study procedures by parent or LAR.
Exclusion Criteria Cohort 1:
- Did not participate in SS-101-18
- Participated in SS-101-18 that withdrew from the study for any reason prior to Visit 9
- Anything that in the opinion of the Investigator is likely to interfere with participation in the registry.
Inclusion Criteria Cohort 2:
- Be less than 120 days old at the time of enrollment
- Provision of signed and dated informed consent form (ICF) by parent or legally authorized representative (LAR)
- Stated willingness to comply with all study procedures by parent or LAR.
Exclusion Criteria Cohort 2:
- Participation in SS-101-18
- Anything that, in the opinion of the Investigator, is likely to interfere with participation in the registry.
- In the opinion of the investigator, has a diagnosed medical condition or genetic abnormality known to impact growth or development.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Случай-контроль
Центры проведения
США · 9 центров
- Alabama Clinical Therapeutics, LLC (Cohort 1) — Birmingham
- Watching Over Mothers & Babies (Cohort 1) — Tuscan
- The Children's Clinic of Jonesboro (Cohort 1) — Jonesboro
- Clinical Research Prime (Cohort 1) — Idaho Falls
- Pediatric Associates Mt. Carmel (Cohort 1) — Cincinnati
- Coastal Pediatric Research (Cohort 1) — Charleston
- Coastal Pediatric Research (Cohort 1) — Summerville
- Holston Medical Group (Cohort 1) — Kingsport
- … и ещё 1 центр
Идентификаторы
NCT: NCT05049655 · BH-10118-02