CompletedNot Applicable

Psychomotor Therapy for Very Premature Infants

France162 participantsStarted 2007-12-01

Plain-language summary

Our current reflexion is that sensory dys-stimulations, including vestibule-proprioceptive disorders and unbalanced between brain and brainstem maturation of the neonatal period involve an early deviant development for immature infants that will be cascaded through the brain scaffolding and later development. The primary purpose is to determine whether the Early Psychomotor Therapy Intervention Program improves development and behavior in very preterm infants (VPI) at 24-month corrected age (CA).

Who can participate

Age range

24 Weeks – 30 Weeks

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: * Infants with a gestational age between 24 and 30 weeks. Exclusion Criteria: * Infants with congenital disease, * Infants with brain bleeding grade III-IV, * Infants with periventricular leucomalacia, * Infants whose mothers had a documented history of physical or mental illness, or drug abuse * Infants from non-French -speaking families.

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

Psychomotor development assessment.

Timeframe: Year 2

Trial details

NCT IDNCT03093337

SponsorUniversity Hospital, Toulouse

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-12-01

View on ClinicalTrials.gov More Premature Infant trials