Идёт набор NCT07750379

Assessing the Role of Proton Pump Inhibitors in Reducing Aspiration Incidence in Pediatric Laryngomalacia Cases

Без фазы С лечением Laryngomalacia

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: PPI, vitamin D, feeding instruction.
Кому может быть актуально: Состояния в реестре: Laryngomalacia. Базовые параметры: 6 мес. — 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: Египет
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Laryngomalacia is the most common congenital laryngeal anomaly in children and is frequently associated with aspiration. This randomized controlled study aims to assess the role of proton pump inhibitor (PPI) therapy in reducing the incidence of aspiration in pediatric patients with laryngomalacia. Eligible participants will be randomly assigned to either a PPI treatment group or a control group. Clinical and swallowing assessments will be performed to compare aspiration incidence and swallowing outcomes between the two groups

Подробное описание

Laryngomalacia is the most common congenital laryngeal anomaly in infants and is frequently associated with feeding difficulties and aspiration. Gastroesophageal reflux has been suggested to contribute to symptom severity and aspiration in these patients. Although proton pump inhibitors (PPIs) are commonly prescribed, evidence regarding their effectiveness in reducing aspiration is still limited.

This randomized controlled trial aims to evaluate the role of PPI therapy in reducing the incidence of aspiration in pediatric patients with laryngomalacia. Eligible participants will be randomly assigned to either an intervention group receiving PPI therapy in addition to standard care or a control group receiving standard care alone. Standard care will include vitamin D supplementation and feeding instructions for all participants. Clinical evaluation and swallowing assessment will be performed at baseline and during follow-up. The incidence of aspiration and swallowing outcomes will be compared between the two groups to determine the effectiveness of adding PPI therapy to standard management. The results of this study may provide evidence to optimize the management of pediatric laryngomalacia and reduce aspiration-related complications.

Вмешательства

Препарат PPI
Proton pump inhibitor therapy administered according to the study protocol
Пищевая добавка vitamin D
Vitamin D supplementation administered according to the study protocol.
Поведенческое feeding instruction
Standard feeding instructions provided to caregivers according to the study protocol.

Первичные конечные точки

Incidence of aspiration [Срок оценки: 2months]

Критерии участия

Критерии включения

Children diagnosed with laryngomalacia by laryngoscopic examination with a history of recurrent choking attacks or aspiration symptoms.
Children aged from 6 months to 5 years.