Infant BehaviorNCT03153839
Influence of the Aquatic Physical Activity for the Neurologic Development of the Babies
A study testing Aquatic physical activity in babies in people with Infant Behavior and Gestational Age Over 30 Weeks, run by Universidad de Granada at 1 site in Spain.
Trial summary
Introduction: physical activity in infants through aquatic therapy is widely known for the later development of sensory ,cognitive and motor areas. In this way, babies will have a greater sense of freedom, pleasure and memory of the maternal uterus. Read more about this study
- Who is it for?
- Ages 3 to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Infant Behavior, Gestational Age Over 30 Weeks
- What is being tested?
- Aquatic physical activity in babies
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2016to Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Commitment to participate voluntarily.
- Signing informed consent to participate in the research, according to the Helsinki Declaration, updated at the 64th General Assembly, Fortaleza, Brazil, October 2013.
Who cannot join
- Babies who are born with a gestational age of less than 30 weeks.
- Baby changes that prevent physical activity.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Universidad de Granda
Granada, 18071
María José Aguilar Cordero, Professor, 657841751 ext. +34, mariajaguilar@telefonica.net
About this study
Introduction: physical activity in infants through aquatic therapy is widely known for the later development of sensory ,cognitive and motor areas. In this way, babies will have a greater sense of freedom, pleasure and memory of the maternal uterus. In addition, the margin therapeutic safety in the water is very broad, which allows an optimal development of aquatic early stimulation programs.
Objective: To determine the relationship between aquatic physical activity in infants and the development of their psychomotor skills in their first year.
Methods: A prospective case-control study will take place for 12 months. Participating infants will be divided in two groups: an experimental group, which will be integrated by 74 babies who will participate with their parents in the aquatic physical activity programme in a heated pool (34-35ºC) and a control group with 71 babies who will not participate in the activities. The aquatic activity will consist on 20 minutes sessions twice a week.
- Conditions
- Infant Behavior, Gestational Age Over 30 Weeks
- Being tested
- Aquatic physical activity in babies
- Keywords
- Children, Babies, Infant, Swimming pool, Aquatic physical activity, Motor development, Neurodevelopment
- Medical subject headings
- Infant Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aquatic physical activity in babiesBehavioural
A programme based on four different types exercises realized in a swimming pool for twelve months.
Before the beginning of the aquatic physical activity, the infants will be evaluated. Afther that, the study group will practise the exercises with their parents in 20 minutes sessions twice a week and when they finish the programme they will be evaluated again.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | 74 infants who will practice with their parents a programme of aquatic physical activity in a swimming pool for one year. They will be evaluated before and after the programme. Receives: Behavioral: Aquatic physical activity in babies |
| Control group | No intervention | 71 infants who will not practice the programme. They only will be evaluated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of baby development
According to the Brunet-Lezine test summarized, evaluating 5 items: motor characteristics, adaptation, language, personal and social behavior and warning signs
Measured: 12 months
Secondary outcomes (10)
Evaluation of the development of affectivity
Test Q-Sort
Measured: 12 months
Gestational age
Weeks of Gestation at birth
Measured: 37- 42 Weeks
Labour alterations
Compiled from clinical history
Measured: 3 months
Apgar at birth
Apgar test
Measured: 3 months
Newborn data
Compiled from clinical history
Measured: 3 months
Type of childbirth
Compiled from clinical history
Measured: 3 months
Nutrition of the baby.
Lactation, formula or complementary feeding
Measured: 12 months
Family demographic variables
Compiled from clinical history
Measured: 3 months
Family history of illness.
Compiled from clinical history
Measured: 3 months
Toxic habits of parents
Compiled from clinical history
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study startOct 2016
- Primary completionJul 2017 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant BehaviorStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 145 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María José Aguilar Cordero, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03153839
- Sponsor's protocol ID
- 25/11/2016 UGR
- Status last verified
- May 2017
- First submitted
- 13 Dec 2016
- Last updated
- 15 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of the Aquatic Physical Activity for the Neurologic Development of the Babies
- ClinicalTrials.gov ID
- NCT03153839
- Acronym / sponsor ID
- 25/11/2016 UGR
- Conditions
- Infant Behavior, Gestational Age Over 30 Weeks
- Keywords
- Children, Babies, Infant, Swimming pool, Aquatic physical activity, Motor development, Neurodevelopment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 145 participants (estimated)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 15 May 2017 (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.
Introduction: physical activity in infants through aquatic therapy is widely known for the later development of sensory ,cognitive and motor areas. In this way, babies will have a greater sense of freedom, pleasure and memory of the maternal uterus. In addition, the margin therapeutic safety in the water is very broad, which allows an optimal development of aquatic early stimulation programs.
Objective: To determine the relationship between aquatic physical activity in infants and the development of their psychomotor skills in their first year.
Methods: A prospective case-control study will take place for 12 months. Participating infants will be divided in two groups: an experimental group, which will be integrated by 74 babies who will participate with their parents in the aquatic physical activity programme in a heated pool (34-35ºC) and a control group with 71 babies who will not participate in the activities. The aquatic activity will consist on 20 minutes sessions twice a week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Behavioral: Aquatic physical activity in babies74 infants who will practice with their parents a programme of aquatic physical activity in a swimming pool for one year. They will be evaluated before and after the programme. |
| Control group | No intervention | –71 infants who will not practice the programme. They only will be evaluated. |
Who may qualify
- Ages
- 3 to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Commitment to participate voluntarily.
- Signing informed consent to participate in the research, according to the Helsinki Declaration, updated at the 64th General Assembly, Fortaleza, Brazil, October 2013.
Key exclusion criteria (2 listed)
- Babies who are born with a gestational age of less than 30 weeks.
- Baby changes that prevent physical activity.
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 physical activity in babiesA programme based on four different types exercises realized in a swimming pool for twelve months. Before the beginning of the aquatic physical activity, the infants will be evaluated. Afther that, the study group will practise the exercises with their parents in 20 minutes sessions twice a week and when they finish the programme they will be evaluated again. | Behavioural | Study group |
Primary outcome
Evaluation of baby development
Time frame: 12 months
According to the Brunet-Lezine test summarized, evaluating 5 items: motor characteristics, adaptation, language, personal and social behavior and warning signs
10 secondary outcomes
Evaluation of the development of affectivity
Time frame: 12 months
Gestational age
Time frame: 37- 42 Weeks
Labour alterations
Time frame: 3 months
Apgar at birth
Time frame: 3 months
Newborn data
Time frame: 3 months
Type of childbirth
Time frame: 3 months
Nutrition of the baby.
Time frame: 12 months
Family demographic variables
Time frame: 3 months
Family history of illness.
Time frame: 3 months
Toxic habits of parents
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2017.
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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. This study is not recruiting at the moment.
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 physical activity in babies in people with Infant Behavior and Gestational Age Over 30 Weeks, run by Universidad de Granada at 1 site in Spain.
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 2 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: status not confirmed, as of the sponsor's last update on 15 May 2017. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact María José Aguilar Cordero, Professor (657841751 ext. +34, mariajaguilar@telefonica.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of baby development (time frame: 12 months). 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 15 May 2017.