Infant Development and Early Aquatic Stimulation

NCT ID: NCT07204613

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-13
• Study Completion Date: 2025-12-31

Brief Summary

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.

Conditions

Infant Health; Child Development

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Experimental Group: Aquatic Stimulation

Aquatic stimulation for babies up to one year of age, involving activities supervised by trained monitors, which aim to stimulate motor, cognitive, language and social development.

Group Type: EXPERIMENTAL

Aquatic stimulation for child development

Intervention Type: BEHAVIORAL

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 supervisors. Two will be inside the pool offering support and encouragement to parents and infants, and one will be outside the pool providing overall supervision of the children and controlling the time of each activity. The activities included in the aquatic intervention plan involve stimulation of expressive language, cognitive development, gross motor skills, fine motor skills, and social interaction.

Control Group: Waiting List

The control group will consist of children who will remain on the waiting list to actively participate in aquatic stimulation after the research period.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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 supervisors. Two will be inside the pool offering support and encouragement to parents and infants, and one will be outside the pool providing overall supervision of the children and controlling the time of each activity. The activities included in the aquatic intervention plan involve stimulation of expressive language, cognitive development, gross motor skills, fine motor skills, and social interaction.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion Criteria

• 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.

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 7 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Federal University of the Valleys of Jequitinhonha and Mucuri

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Universidade Federal dos Vales do Jequitinhonha e Mucuri

Diamantina, Minas Gerais, Brazil

Countries

Brazil

Other Identifiers

68410223.3.0000.5108

Identifier Type: -

Identifier Source: org_study_id