Prevalence and Natural History of Functional Gastrointestinal Disorders Among At-risk 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: Questionnaire, clinical examination.
- Кому может быть актуально
- Состояния в реестре: Functional Gastrointestinal Disorders, Gastroesophageal Reflux, Constipation - Functional, Diarrhea. Базовые параметры: 3 мес. — 24 мес. · 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
- Италия
- 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
Prospective Assessment of the Prevalence and Natural History of Gastroesophageal Reflux and Functional Gastro-intestinal Disorders Among At-risk Infants
Обзор
The goal of this observational study is to learn about the prevalence and characteristics of functional gastrointestinal disorders (FGID) in at risk infants (former preterm infants and those with birth asphyxia) during the first 2 years of life. The main questions it aims to answer are: * evaluate the prevalence of symptoms related to gastro-esophageal reflux (GER), of functional gastrointestinal disorders during the first 2 years of life * describe growth parameters during follow-up up to the corrected age of 2 years Participants will be assessed clinically and with a structured questionnaire based on the Rome IV criteria to describe FGID.
Подробное описание
Infants will undergo clinical assessment at 3, 6, 12, 24 months' corrected age at the local Follow-up clinic.
Clinical examination, anthropometric measurement and data from a structured questionnaire to detect FGID will be performed.
Z-scores for weight, length and head circumference will be calculated according to the World Health Organization (WHO) standards.
Data from the questionnaires will be collected. Clinical characteristics of patients and perinatal data will be collected and analyzed by appropriate statistical methods.
The prevalence and characteristics of FGID in the study population will be compared to published data (mostly from term infants).
Вмешательства
- Другое Questionnaire, clinical examination
At each follow up visit, a clinical examination and anthropometric evaluation will be performed. Parents will fill a structured questionnaire to describe the occurrence and characteristics of functional gastrointestinal disorders.
Первичные конечные точки
- Prevalence of FGID [Срок оценки: 3, 6, 12, 24 months of corrected age]
- Frequency of FGID [Срок оценки: 3, 6, 12, 24 months of corrected age]
- Severity of FGID [Срок оценки: 3, 6, 12, 24 months of corrected age]
Вторичные конечные точки (3)
- Somatic growth: weight [Срок оценки: 3, 6, 12, 24 months of corrected age]
- Somatic growth: head circumference [Срок оценки: 3, 6, 12, 24 months of corrected age]
- Somatic growth: length [Срок оценки: 3, 6, 12, 24 months of corrected age]
Критерии участия
Критерии включения
- infants with gestational age at birth < 31 weeks
- infants with gestational age at birth < 37 weeks and major respiratory or neurologic morbidity
- infants with history of perinatal asphyxia
Критерии исключения
- lack of informed consent
- diagnosis of congenital or other major gastrointestinal disease (i.e. inflammatory bowel disease, cancer)
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Италия · 1 центр
- Fondazione Policlinico Gemelli IRCCS — Roma
Публикации
- Steutel NF, Zeevenhooven J, Scarpato E, Vandenplas Y, Tabbers MM, Staiano A, Benninga MA. Prevalence of Functional Gastrointestinal Disorders in European Infants and Toddlers. J Pediatr. 2020 Jun;221:107-114. doi: 10.1016/j.jpeds.2020.02.076. PMID 32446468
- Robin SG, Keller C, Zwiener R, Hyman PE, Nurko S, Saps M, Di Lorenzo C, Shulman RJ, Hyams JS, Palsson O, van Tilburg MAL. Prevalence of Pediatric Functional Gastrointestinal Disorders Utilizing the Rome IV Criteria. J Pediatr. 2018 Apr;195:134-139. doi: 10.1016/j.jpeds.2017.12.012. Epub 2018 Feb 3. PMID 29398057
- Benninga MA, Faure C, Hyman PE, St James Roberts I, Schechter NL, Nurko S. Childhood Functional Gastrointestinal Disorders: Neonate/Toddler. Gastroenterology. 2016 Feb 15:S0016-5085(16)00182-7. doi: 10.1053/j.gastro.2016.02.016. Online ahead of print. PMID 27144631
- Iacono G, Merolla R, D'Amico D, Bonci E, Cavataio F, Di Prima L, Scalici C, Indinnimeo L, Averna MR, Carroccio A; Paediatric Study Group on Gastrointestinal Symptoms in Infancy. Gastrointestinal symptoms in infancy: a population-based prospective study. Dig Liver Dis. 2005 Jun;37(6):432-8. doi: 10.1016/j.dld.2005.01.009. Epub 2005 Mar 2. PMID 15893282
- Scarpato E, Salvatore S, Romano C, Bruzzese D, Ferrara D, Inferrera R, Zeevenhooven J, Steutel NF, Benninga MA, Staiano A. Prevalence and Risk Factors of Functional Gastrointestinal Disorders: A Cross-Sectional Study in Italian Infants and Young Children. J Pediatr Gastroenterol Nutr. 2023 Feb 1;76(2):e27-e35. doi: 10.1097/MPG.0000000000003653. Epub 2022 Nov 1. PMID 36705695
Идентификаторы
NCT: NCT06031025 · 4921