Massage Therapy in Premature Neonates (NCT06163586) | Clinical Trial Compass
CompletedNot Applicable
Massage Therapy in Premature Neonates
United States32 participantsStarted 2023-11-01
Plain-language summary
The goal of this clinical trial is to learn about the effects of Neonatal Touch and Massage Therapy on premature babies.
The main questions it aims to answer are:
* Do babies who receive Neonatal Touch and Massage Therapy get discharged sooner from the NICU
* Does Neonatal Touch and Massage Therapy have a beneficial effect on weight gain, pain and stress responses, and neurodevelopmental outcomes.
Participants assigned to the treatment group will receive Neonatal Touch and Massage Therapy while admitted to the NICU. Researchers will compare their outcomes to a control group, receiving standard NICU care, to see if there are any differences in the length of hospital stay, weight gain, pain scores, neurodevelopmental outcomes, and incidence of other common conditions associated with prematurity.
Who can participate
Age range
24 Weeks – 32 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 born or admitted to University of Maryland NICU in the first 14 days of life
* Gestational age greater than 23 6/7 weeks and less than 32 weeks at birth
* Deemed medically stable by the medical care team
Exclusion Criteria:
* Life limiting conditions, including genetic syndromes
* Cyanotic heart disease
* Requiring major surgery or critically ill at time of intervention
* Osteopenia of prematurity with an existing fracture
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
Length of stay
Timeframe: Day of birth to discharge home, up to 6 months