Infant Massage for Lymphedema and Comfort in Preterm Newborns (NCT07418814) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Infant Massage for Lymphedema and Comfort in Preterm Newborns
40 participantsStarted 2026-04-01
Plain-language summary
This randomized controlled trial investigates the effectiveness of infant massage in reducing symptoms of immobilization-related lymphedema and improving comfort in preterm newborns hospitalized in the Neonatal Intensive Care Unit (NICU). Preterm infants frequently develop lymphedema due to their immature circulatory systems and prolonged lack of movement.
The study compares two groups of infants: one receiving standard care and another receiving a daily 15-minute massage therapy session for 14 consecutive days in addition to standard care. Researchers will evaluate the impact of the massage by measuring the circumference of the infants' wrists, elbows, ankles, and knees to assess fluid reduction. Additionally, the infants' comfort levels will be assessed using the Premature Infant Comfort Scale (PICS). The goal is to determine if massage can serve as a safe, non-invasive method to manage lymphedema and reduce distress in this vulnerable population.
Who can participate
Age range
28 Weeks – 37 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:
To ensure a homogenous and clinically stable sample, infants meeting the following criteria will be recruited:
* Clinical diagnosis of lymphedema.
* Hemodynamic and clinical stability.
* No current or recent (within 24 hours) administration of analgesic or sedative medications that could mask comfort assessments.
* Intact skin integrity with no contraindications for topical massage.
* Absence of congenital heart disease or neurological disorders (antenatal or postnatal diagnosis).
* No immediate requirement for endotracheal aspiration.
* Requirement for only non-invasive respiratory support (e.g., nCPAP).
* Provision of written informed consent by the legal guardians (parents).
Exclusion Criteria:
Infants will be excluded if they present with:
* Major congenital anomalies.
* Severe respiratory, cardiac, or neurological instability during the study period.
* Any acute medical contraindication identified by the attending neonatologist.
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.