Effectiveness of a Training Program for Parents of Babies in Their First Year of Life to Achieve … (NCT04693494) | Clinical Trial Compass
CompletedNot Applicable
Effectiveness of a Training Program for Parents of Babies in Their First Year of Life to Achieve Motor Milestones
Spain82 participantsStarted 2019-12-01
Plain-language 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. The purpose of this study is to know if motor development can be improved by the environment.
Who can participate
Age range
1 Day – 9 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* Newborns who have required hospitalization before being enrolled.
* Multiple births
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Score of the Alberta Infant Motor Scale (AIMS) at month 9
Timeframe: 9 months old
2
Score of the Alberta Infant Motor Scale (AIMS) at month 12
Timeframe: 12 months old
3
Score of the Alberta Infant Motor Scale (AIMS) at month 15