RecruitingNot Applicable

Evaluation of a Sensory-tonic Stimulation on Development of Parent-infant Interactions and Social Cognition in Very Premature Children

France120 participantsStarted 2023-01-19

Plain-language summary

Attachment is built primarily on the first interactions of the first 9 months of a baby's life. These first interactions and their effects of stress, pleasure and displeasure are retained to establish some of the baby's attachment behaviours and future relationships with others. Extreme prematurity strongly modify these first interactions between parents and child. Very preterm child is separated from his parents and is placed in a stressful, technical and potentially painful environment. Early interventions stimulate neuroplasticity and can positively affect the neurological development of very preterm infant. Tactile stimuli such as skin-to-skin contact and massages carried out by parents can be pleasant experiences that can support early interactions between parents and child.

Who can participate

Age range

1 Day

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 : * very preterm child (born before 32 weeks of amenorrhoea) * parents agreeing to participate to the study exclusion criteria : * child born before 25 weeks of amenorrhoea * child with a birth weight less than 600 grams * child with congenital malformation * child with hemodynamic instability

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

interactions between parents and child

Timeframe: 12 months

Trial details

NCT IDNCT04380051

SponsorCHU de Reims

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-01-19

Contact for this trial

Gauthier Loron

0326787878 gloron@chu-reims.fr

View on ClinicalTrials.gov More Very Preterm Birth trials