Infant Development and Early Aquatic Stimulation

NCT07204613 | Enrolling By Invitation

• 1 other identifier: 68410223.3.0000.5108
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

Aquatic Therapy; Child Development

Outcome Measures

Primary Outcomes (2)

• Feasibility of the Intervention Protocol

  Measure Unit: Composite Score (0-100) Description: A single feasibility score will be calculated by aggregating multiple indicators: number of sessions attended/missed, dropout rate, impact of inclusion/exclusion criteria on recruitment, rate of adverse events, parental satisfaction, and adherence to protocol activities. Each indicator will be scored and combined into a composite score ranging from 0 (lowest feasibility) to 100 (highest feasibility), reflecting the overall feasibility of the intervention protocol.

  4 months

• Child Development

  Child development will be assessed using the Bayley-III instrument. The assessment begins with age-appropriate tasks and is scored as 1 if the task is completed and 0 if it is not. The assessment ends when the child fails five consecutive tasks. Each domain generates a raw score, which can be converted into balanced and composite scores using tables provided in the manual. The balanced score will classify the child from 1 to 19. The mean is 10 and a standard deviation of ±3 points, being classified as expected (7 to 13 points), below expected (\<7 points), and above expected (\<13 points). The composite score is based on age norms, classifying the child from 40 to 160. The mean score is 100, with a standard deviation of ±15 points.

  From registration to end of re-evaluation = 5 months

Secondary Outcomes (4)

• Socioeconomic classification of the family

  4 months

• Opportunity for motor stimulation at home

  4 months

• Global Development and Child Behavior

  4 months

• Sociodemographic and biological factors that can influence child development

  1 day

Study Arms (2)

Experimental Group: Aquatic Stimulation

EXPERIMENTAL

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.

Behavioral: Aquatic stimulation for child development

Control Group: Waiting List

NO INTERVENTION

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

Interventions

Aquatic stimulation for child development 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.

Experimental Group: Aquatic Stimulation

Eligibility Criteria

• Age: 3 Months - 7 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of the Valleys of Jequitinhonha and Mucuri: lead

Study Sites (1)

Universidade Federal dos Vales do Jequitinhonha e Mucuri

Diamantina, Minas Gerais, 39.100-000, Brazil

Location

MeSH Terms

Interventions

Child Development

Intervention Hierarchy (Ancestors)

Human Development; Growth and Development; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2025
• First Posted: October 2, 2025
• Study Start: August 13, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 2, 2025

Record last verified: 2025-09

Locations

BR (1)