Efficacy of Massage Applied by the Parents in Hospitalized Premature Birth (PreMas) (NCT03704012) | Clinical Trial Compass
CompletedNot Applicable
Efficacy of Massage Applied by the Parents in Hospitalized Premature Birth (PreMas)
143 participantsStarted 2012-09-01
Plain-language summary
The purpose of this study was to analyze the efficacy of massage therapy and kinesiotherapy, applied by the parents of hospitalized preterm infants, in the improvement of the biological state, neuromotor activity and other associated factors.
Who can participate
Age range
26 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:
* Gestational age between 26 to 37 gestational weeks.
* Low birth weight, less than 2249 grams.
* Weight of at least 1250 grams at time of entry into study.
* Must be at least 48 hours of age.
* Must have hemodynamic stability.
* Absence of congenital and genetic anomalies.
* Absence of alterations of the central nervous system.
* Intact skin.
* Stable parameters (according to the neonatologist´s criteria) to participate in the intervention.
Exclusion Criteria:
* Family refusal to participate in the study.
* High frequency mechanical ventilation.
* Fraction of Inspired Oxygen (FiO2)\>70%.
* Inotropic support.
* Septic shock.
* Persistent tachycardia.
* Persistent bradycardia.
* Gastrointestinal disorders.
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
Effect on weight
Timeframe: From baseline to hospital discharge, approximately 10 days
2
Effect of lenght
Timeframe: From baseline to hospital discharge, approximately 10 days
3
Effect on head circumference
Timeframe: From baseline to hospital discharge, approimately 10 days
4
Effect on neuromotor development
Timeframe: From baseline to up to 37 gestational weeks