TermNCT04693494
Effectiveness of a Training Program for Parents of Babies in Their First Year of Life to Achieve Motor Milestones
A study testing Training program in people with Term and Healthy, run by Universidad San Jorge at 1 site in Spain.
Trial summary
this study compares motor development of two groups of healthy term babies at the end of their first year of life. Parents of the intervention group have received a training program consisting in advices about correct positions, stimuli, how to play or how to carry their babies. Read more about this study
- Who is it for?
- Ages 1 day to 9 monthsHealthy volunteers can take part
- Conditions the study is for
- Term, Healthy, Motor Delay
- What is being tested?
- Training program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2019to 17 Jan 2023
- 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 1 day to 9 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy-term infants
- Male and female
- Apgar score of at least 7 in the first minute and at five minutes.
- Natural or cesarean birth
- Absence of congenital malformations or orthopedic injury
- Absence of known congenital or genetic pathology
- Normal neurological medical examination of the newborn at hospital discharge.
Who cannot join
- Newborns who have required hospitalization before being enrolled.
- Multiple births
Trial locations and contacts
1 site in 1 country.
About this study
this study compares motor development of two groups of healthy term babies at the end of their first year of life. Parents of the intervention group have received a training program consisting in advices about correct positions, stimuli, how to play or how to carry their babies. The purpose of this study is to know if motor development can be improved by the environment.
Read the detailed description
Infants in both groups are recruited by the principal investigator at the hospital within two to three days after birth. An initial assessment was carried out at 2 months of age.
Intervention group:
- Four training sessions (before the baby is 1 month old, at 3 months, at 6, and at 9 months old) teaching the main motor milestones to get in the next 3 months and how to help infants with the correct stimuli, positions or plays; triptychs containing the main points explained at the session and links to short videos about the given bits of advice.
- Three evaluations of motor milestones at 9, 12, and 15 months old.
Control group:
- Three evaluations of motor milestones at 9, 12, and 15 months old.
- Conditions
- Term, Healthy, Motor Delay, Development, Infant
- Being tested
- Training program
- Keywords
- motor milestones, term, newborn, motor development
- Medical subject headings
- Psychomotor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training programOther
Training program consisting in 4 sessions with information about milestones to achieve and advices for motor development. Triptychs and short videos containing the main points containing the main points.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Four training sessions (before the baby is 1 month old, at 3 months, at 6 and at 9 months old) teaching the main motor milestones to get in the next 3 months and how to help infants with the correct stimuli, positions or plays; triptychs containing the main points explained at the session and links to short videos about the given advices.
Three evaluations of motor milestones at the age of 9, 12, and 15 months old Receives: Other: Training program |
| Control group | No intervention | Three evaluations of motor milestones at the age of 9, 12, and 15 months old |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score of the Alberta Infant Motor Scale (AIMS) at month 9
AIMS is a validated observational scale for measurement of motor milestones. Higher scores mean a better outcome. Depending on the score, the percentile is obtained.
Measured: 9 months old
Score of the Alberta Infant Motor Scale (AIMS) at month 12
AIMS is a validated observational scale for measurement of motor milestones. Higher scores mean a better outcome. Depending on the score, the percentile is obtained.Depending on the score, the percentile is obtained.
Measured: 12 months old
Score of the Alberta Infant Motor Scale (AIMS) at month 15
AIMS is a validated observational scale for measurement of motor milestones. Higher scores mean a better outcome. Depending on the score, the percentile is obtained.
Measured: 15 months old
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start1 Dec 2019
- Primary completion7 Dec 2020
- Study completion17 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TermStudies 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
- Model description
- Intervention and control group.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad San Jorge
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luis Fernandez, Universidad San Jorge
- Investigators
- Luis Fernández Sola, Physical Th, Principal investigator, Universidad San JorgeBeatriz Cano Díez, Physical Th, Study director, Universidad San Pablo CEU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04693494
- Sponsor's protocol ID
- ufernandez2020
- Status last verified
- May 2024
- First submitted
- 28 Dec 2020
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD after deidentified
Publications
Fernandez-Sola L, Cano-Diez B, Pons-Solaz Y, Vera-Egido B, Moreno-Gonzalez S. Effectiveness of a training program for the acquisition of motor milestones in infants: a randomized clinical trial. Ital J Pediatr. 2025 Jan 31;51(1):23. doi: 10.1186/s13052-025-01849-4.
PubMed 39891196
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Training Program for Parents of Babies in Their First Year of Life to Achieve Motor Milestones
- ClinicalTrials.gov ID
- NCT04693494
- Acronym / sponsor ID
- ufernandez2020
- Conditions
- Term, Healthy, Motor Delay, Development, Infant
- Keywords
- motor milestones, term, newborn, motor development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Universidad San JorgeUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 7 Dec 2020 (actual)
- Study completion
- 17 Jan 2023 (actual)
- First posted
- 5 Jan 2021 (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.
this study compares motor development of two groups of healthy term babies at the end of their first year of life. Parents of the intervention group have received a training program consisting in advices about correct positions, stimuli, how to play or how to carry their babies. The purpose of this study is to know if motor development can be improved by the environment.
Detailed description
Infants in both groups are recruited by the principal investigator at the hospital within two to three days after birth. An initial assessment was carried out at 2 months of age.
Intervention group:
- Four training sessions (before the baby is 1 month old, at 3 months, at 6, and at 9 months old) teaching the main motor milestones to get in the next 3 months and how to help infants with the correct stimuli, positions or plays; triptychs containing the main points explained at the session and links to short videos about the given bits of advice.
- Three evaluations of motor milestones at 9, 12, and 15 months old.
Control group:
- Three evaluations of motor milestones at 9, 12, and 15 months old.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Intervention and control group.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Training programFour training sessions (before the baby is 1 month old, at 3 months, at 6 and at 9 months old) teaching the main motor milestones to get in the next 3 months and how to help infants with the correct stimuli, positions or plays; triptychs containing the main points explained at the session and links to short videos about the given advices. Three evaluations of motor milestones at the age of 9, 12, and 15 months old |
| Control group | No intervention | –Three evaluations of motor milestones at the age of 9, 12, and 15 months old |
Who may qualify
- Ages
- 1 day to 9 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Healthy-term infants
- Male and female
- Apgar score of at least 7 in the first minute and at five minutes.
- Natural or cesarean birth
- Absence of congenital malformations or orthopedic injury
Key exclusion criteria (2 listed)
- Newborns who have required hospitalization before being enrolled.
- Multiple births
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 |
|---|---|---|
| Training programTraining program consisting in 4 sessions with information about milestones to achieve and advices for motor development. Triptychs and short videos containing the main points containing the main points. | Other | Intervention group |
Primary outcome
Score of the Alberta Infant Motor Scale (AIMS) at month 9
Time frame: 9 months old
AIMS is a validated observational scale for measurement of motor milestones. Higher scores mean a better outcome. Depending on the score, the percentile is obtained.
Score of the Alberta Infant Motor Scale (AIMS) at month 12
Time frame: 12 months old
AIMS is a validated observational scale for measurement of motor milestones. Higher scores mean a better outcome. Depending on the score, the percentile is obtained.Depending on the score, the percentile is obtained.
Score of the Alberta Infant Motor Scale (AIMS) at month 15
Time frame: 15 months old
AIMS is a validated observational scale for measurement of motor milestones. Higher scores mean a better outcome. Depending on the score, the percentile is obtained.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Derived from this study: PubMed 39891196Fernandez-Sola L, Cano-Diez B, Pons-Solaz Y, Vera-Egido B, Moreno-Gonzalez S. Effectiveness of a training program for the acquisition of motor milestones in infants: a randomized clinical trial. Ital J Pediatr. 2025 Jan 31;51(1):23. doi: 10.1186/s13052-025-01849-4.
- Individual participant dataSharing planned: Yes. All collected IPD after deidentified
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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.
Luis Fernández Sola, Physical Th principal investigator
Universidad San Jorge
Beatriz Cano Díez, Physical Th study director
Universidad San Pablo CEU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training program in people with Term and Healthy, run by Universidad San Jorge 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 7 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: finished, as of the sponsor's last update on 16 May 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Score of the Alberta Infant Motor Scale (AIMS) at month 9 (time frame: 9 months old). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04693494, which also lists 1 linked publication.
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 16 May 2024.