Daily Skin-to-Skin Contact Duration in Preterm and Low Birth Weight Infants Admitted to a Kangaro… (NCT07747870) | Clinical Trial Compass
CompletedNot Applicable
Daily Skin-to-Skin Contact Duration in Preterm and Low Birth Weight Infants Admitted to a Kangaroo Care Unit
France240 participantsStarted 2021-06-10
Plain-language summary
Kangaroo Mother Care promotes prolonged skin-to-skin contact between newborns and their parents. Although this practice is routinely encouraged in Kangaroo Care Units, the daily duration of skin-to-skin contact varies substantially between families.
This prospective observational study aims to estimate the average daily duration of skin-to-skin contact among newborns admitted to the Kangaroo Unit at Valenciennes Hospital and to identify maternal, neonatal, and organizational factors associated with this practice.
This non-interventional study does not modify routine clinical care. Data are collected from routinely available medical records, a brief parental questionnaire completed at enrollment, and the daily recording of skin-to-skin contact performed throughout hospitalization.
The study will provide a description of skin-to-skin practice in a specialized Kangaroo Unit and may help inform future strategies to support the implementation of Kangaroo Mother Care.
Who can participate
Age range
1 Minute – 72 Hours
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:
* Preterm newborn with a gestational age between 33 weeks 0 days and 34 weeks 6 days and/or a birth weight of 1500g and 2000 g
* admitted to the Kangaroo Unit within the first 72 hours after birth
Exclusion Criteria:
* Mother-infant separation lasting more than 72 hours after birth
* Triplet or higher-order multiple pregnancy
* Refusal of participation by one or both parents
* Cognitive impairment preventing provision of study information to a parent and/or collection of study data
* Inability to communicate with the parents (e.g. language barrier)
* Mother deprived of liberty
* No health insurance coverage
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
Average daily duration of skin-to-skin contact
Timeframe: Up to 25 days (until discharge from the Kangaroo Unit)