Infant Development and Early Aquatic Stimulation

Официальное название

The Effect of Aquatic Stimulation on the Development of Infants in the First Year of Life: A Pilot Study of a Randomized Controlled Clinical Trial

Обзор

The objective of this study is to assess the feasibility of an aquatic stimulation protocol for infants up to one year of age. The main questions to be answered are: Is the aquatic stimulation program, which involves recruitment, intervention, and reassessment, feasible and feasible on a larger scale? Was the aquatic stimulation protocol able to promote improvements in child development compared to the control group? Researchers will compare the intervention group with a control group, which will be included on the waiting list, to determine whether aquatic stimulation promotes improved child development. Eligible participants will be assessed, and then a random selection will be made by an independent researcher to determine the control and experimental groups. The experimental group will receive aquatic stimulation through a group class, with activities that stimulate language, cognitive, fine and gross motor skills, as well as social interaction. The control group will remain on the waiting list throughout the intervention. Monthly messages will be sent to both groups to collect information about the infant's health. Interventions will occur twice a week for 45 minutes over a three-month period. Immediately afterward, the children and their parents/guardians will be reevaluated. Children in the control group will be guaranteed a spot to receive aquatic stimulation after the intervention period. The data will be tabulated, analyzed, and subsequently published scientifically.

Вмешательства

• Поведенческое Aquatic stimulation for child development
  The intervention will be conducted in a heated pool located in the Physiotherapy building of the Federal University of Jequitinhonha and Mucuri Valleys, Diamantina, Minas Gerais, Brazil. A total of 24 twice-weekly, 45-minute aquatic stimulation sessions will be offered over a 13-week intervention period. The sessions will follow a previously tested and refined aquatic stimulation protocol for infants. The experimental group will consist of 15 dyads (infant + parent or guardian) and three supervi

Первичные конечные точки

• Feasibility of the Intervention Protocol [Срок оценки: 4 months]
• Child Development [Срок оценки: From registration to end of re-evaluation = 5 months]

Вторичные конечные точки (4)

• Socioeconomic classification of the family [Срок оценки: 4 months]
• Opportunity for motor stimulation at home [Срок оценки: 4 months]
• Global Development and Child Behavior [Срок оценки: 4 months]
• Sociodemographic and biological factors that can influence child development [Срок оценки: 1 day]

Критерии участия

Критерии включения

• Children aged 3 months to 7 months and 29 days with expressed interest from their parents and/or guardians in participating in the outreach project "Nada Melhor: Aquatic Stimulation for Babies";
• Participation in the research with authorization and consent from their parents or guardians.
• Availability to attend aquatic stimulation classes on previously defined days and times (Tuesdays and Thursdays, 6:00 PM to 7:00 PM).

Критерии исключения

• Children with neurological disorders such as cerebral palsy or syndromes affecting cognitive, linguistic, and motor skills, mental or psychiatric disorders, and autism;
• Children with prior experience in an aquatic environment under the supervision of a professional.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Бразилия · 1 центр

• Universidade Federal dos Vales do Jequitinhonha e Mucuri — Diamantina

Идентификаторы

NCT: NCT07204613 · 68410223.3.0000.5108

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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