Researchers At UC San Diego Are Learning About the Benefits of Human Milk and How It Influences Infant and Child Health
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: COVID-19 Exposure, Antibiotic.
- Кому может быть актуально
- Состояния в реестре: Breastfeeding, COVID-19 Infection, COVID-19 Vaccine, Remdesivir. Базовые параметры: от 18 лет · Женщины.
- 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 →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
The UCSD Human Milk Biorepository
Обзор
The purpose of the UCSD Human Milk Biorepository is to establish and maintain a repository of breast milk samples that can be used to learn more about how breast milk influences infant and child health.
Подробное описание
Participants in this study will participate in the following:
1. Provide a milk sample:
If participants agree, the investigators will ask participants to express 50ml (about 2 ounces) of milk. The investigators will take as much as participants wish to donate, or as little as one teaspoon. 2. Answer questions about participant's health:
Future researchers may need to know if participants have any health problems, or about any treatments participants have had while breastfeeding. The investigators will ask participants for some contact information, health habits, and family's health history. 3. Fill out online questionnaires about participant's eating habits and mood:
The investigators will ask the participant to answer an online questionnaire about how often participants eat certain foods.
The investigators will also have the participant answer some questions about the participant's mood and how the participant has been feeling recently. The questionnaires can be completed on a tablet at the visit, or the investigators may send an email with a link to fill it out online. These questionnaires take about 30 minutes altogether. 4. The investigators will store the participant's sample and information in the Human Milk Biorepository:
The investigators will keep the participant's milk and health information in the Human Milk Biorepository. There is no limit on the length of time we will keep the milk and information. The investigators will keep them as long as they are useful, unless the participant asks to remove them. 5. The investigators will let researchers use the stored materials for approved research studies:
Researchers can apply to study the samples and information stored in the Human Milk Biorepository. 6. If the participant agrees, the investigators may contact the participant with information about other research studies.
Вмешательства
- Биопрепарат COVID-19 Exposure
Have been or may have been exposed to COVID-19. - Препарат Antibiotic
Have or have not been prescribed one of several commonly used antibiotics including azithromycin, amoxicillin and clavulanic acid, amoxicillin, or nitrofurantoin.
Первичные конечные точки
- Human Milk Repository [Срок оценки: 1 year]
- Develop, maintain and manage the Repository [Срок оценки: Through study completion, an average of 2 years]
Вторичные конечные точки (3)
- Sub-study 100: COVID-19 Exposure [Срок оценки: Through study completion, an average of 2 years]
- Sub-study 101: Antibiotic Exposure [Срок оценки: Through study completion, an average of 2 years]
- Sub-study 102: P50 MPRINT Admin Supplement [Срок оценки: Through study completion, an average of 2 years]
Критерии участия
Критерии включения
- Women who are 18 years old or older
- Breastfeeding
- Producing sufficient breast milk to donate an excess to the Biorepository
Критерии исключения
- Women under 18 years old
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
США · 1 центр
- University of California, San Diego — San Diego
Публикации
- Bertrand K, Kelly A, Chambers CD. The Prevalence of Nonserious Events in a Cohort of Breastfed Infants. Breastfeed Med. 2023 Jan;18(1):43-47. doi: 10.1089/bfm.2022.0245. Epub 2022 Nov 28. PMID 36454186
Идентификаторы
NCT: NCT05553743 · 130658