Infant HealthNCT07204613
Infant Development and Early Aquatic Stimulation
A study testing Aquatic stimulation for child development in people with Infant Health and Child Development, run by Federal University of the Valleys of Jequitinhonha and Mucuri at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 7 monthsHealthy volunteers can take part
- Conditions the study is for
- Infant Health, Child Development
- What is being tested?
- Aquatic stimulation for child development
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 13 Aug 2025to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 7 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
Universidade Federal dos Vales do Jequitinhonha e Mucuri
Diamantina, Minas Gerais, 39.100-000
About this study
Official title: 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
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?
Read more
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
- Being tested
- Aquatic stimulation for child development
- Keywords
- Aquatic Therapy, Child Development
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aquatic stimulation for child developmentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From registration to end of re-evaluation = 5 months
Secondary outcomes (4)
Socioeconomic classification of the family
For economic classification, the Brazilian Economic Classification Criteria (CCEB) from the Brazilian Association of Research Companies (ABEP) 2018 will be used. This criteria assigns a score based on the assets and education of the head of the household. Based on this score, the family is classified on an ordinal scale from E to A.
Measured: 4 months
Opportunity for motor stimulation at home
The Affordances in the Home Environment for Motor Development (AHEMD) will be used to assess the opportunities children have at home. The instrument has been translated and validated for the Brazilian population and aims to assess the quality and quantity of opportunities for motor stimulation in children's homes. The instrument should be completed based on reports from parents or caregivers. It is divided into two categories, according to the child's age: 2 to 18 months and 18 to 42 months. After completing the questionnaire, the scores for each dimension are calculated by adding the points from the questions and then totaled to obtain the total score. The maximum score for the questionnaire is 20 points, and it can be classified as high (17 to 20 points), medium (10 to 16 points), and low (less than 9 points).
Measured: 4 months
Global Development and Child Behavior
To assess overall development, we used an instrument translated and adapted to the Brazilian version of the "Survey of Well-being of Young Children (SWYC)." This instrument is presented in the form of a compilation of questionnaires, 12 in total, in which each section assesses a domain of the child's well-being, and a score is generated at the end of each domain. Based on this score and the child's age, the administrator can use a table to determine whether the score is the minimum expected for that age. The SWYC can be accessed at: https://www.tuftsmedicine.org/medical-professionals-trainees/academic departments/department-pediatrics/survey-well-being-young-children/age-specific-forms.
Measured: 4 months
Sociodemographic and biological factors that can influence child development
Initially, parents and/or guardians will answer a questionnaire prepared by the authors about sociodemographic and biological data characterizing the sample, such as: sex, age, aspects related to the gestational period, family history, and data on the infant's health and habits.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start13 Aug 2025
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of the Valleys of Jequitinhonha and Mucuri
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07204613
- Sponsor's protocol ID
- 68410223.3.0000.5108
- Status last verified
- Sep 2025
- First submitted
- 29 Aug 2025
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07204613
- Acronym / sponsor ID
- 68410223.3.0000.5108
- Conditions
- Infant Health, Child Development
- Keywords
- Aquatic Therapy, Child Development
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Federal University of the Valleys of Jequitinhonha and MucuriUniversity, hospital or other
- Study start
- 13 Aug 2025 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 2 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group: Aquatic Stimulation | Experimental | Behavioral: Aquatic stimulation for child developmentAquatic 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. |
| 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. |
Who may qualify
- Ages
- 3 to 7 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aquatic stimulation for child developmentThe 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. | Behavioural | Experimental Group: Aquatic Stimulation |
Primary outcome
Feasibility of the Intervention Protocol
Time frame: 4 months
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.
Child Development
Time frame: From registration to end of re-evaluation = 5 months
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.
4 secondary outcomes
Socioeconomic classification of the family
Time frame: 4 months
Opportunity for motor stimulation at home
Time frame: 4 months
Global Development and Child Behavior
Time frame: 4 months
Sociodemographic and biological factors that can influence child development
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aquatic stimulation for child development in people with Infant Health and Child Development, run by Federal University of the Valleys of Jequitinhonha and Mucuri at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the Intervention Protocol (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025; AzTrials last refreshed its copy on 27 Oct 2026.