An interventional study of Infant Massage Group in Lymphedema, Premature Birth and Edema, sponsored by Erzurum Technical University. Not yet recruiting. Open to participants aged 28 Weeks to 37 Weeks. Per ClinicalTrials.gov, last updated 2026-02-18.
Sponsored by Erzurum Technical University · Not applicable, Interventional, and Supportive care
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.
Preterm infants born before the 37th week of gestation frequently encounter health challenges due to immature physiological systems, with lymphedema being a significant clinical concern precipitated by circulatory insufficiency and prolonged immobilization in the Neonatal Intensive Care Unit (NICU). This condition is characterized by abnormal fluid accumulation that, if untreated, can lead to chronic pain, infection risks, and developmental delays. While manual lymphatic drainage is the standard for adults, its application in preterm infants is limited due to skin fragility, and surgical options carry substantial risks. Consequently, there is an urgent need for non-invasive approaches to facilitate fluid movement in the absence of natural physical activity.
Although infant massage is known to enhance weight gain and reduce stress, its specific efficacy in mitigating immobilization-related lymphedema through mechanical drainage has not been rigorously examined. This randomized controlled trial aims to evaluate the clinical effectiveness of infant massage as a non-invasive intervention for reducing lymphedema symptoms and enhancing comfort levels among preterm neonates. The study will be conducted at a Level III NICU, involving preterm infants hospitalized for a minimum of two weeks who meet specific eligibility criteria, including hemodynamic stability and a diagnosis of lymphedema.
Participants will be randomized into an intervention group receiving standardized massage therapy and a control group receiving standard care. The intervention consists of a 15-minute daily massage regimen applied for 14 consecutive days, focusing on affected extremities and lymphatic regions using an oil-free, hypoallergenic formula. Primary outcomes, including extremity circumference measurements (wrist, elbow, ankle, knee) and pitting edema grading, will be assessed on Day 0, Day 7, and Day 14. Secondary outcomes involving neonatal comfort will be evaluated using the Premature Infant Comfort Scale (PICS). The study seeks to determine whether mechanical stimulation can effectively mitigate fluid accumulation and alleviate physiological distress in this vulnerable population.
529 studies on the registry are indexed under Lymphedema; 131 are open to participants now.
This study's planned enrollment of 40 is below the median of 50 across 369 interventional studies indexed under Lymphedema.
Browse Lymphedema studies →Erzurum Technical University is the lead sponsor of 32 studies on the registry; 14 are open to participants now.
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To ensure a homogenous and clinically stable sample, infants meeting the following criteria will be recruited:
Exclusion Criteria:
Infants will be excluded if they present with:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The massage application consists of gentle tactile stimulation targeting the extremities and lymphatic drainage pathways. The therapy is performed for 15 minutes once daily for 14 days by a trained researcher/nurse. The technique is adapted for preterm physiology to ensure safety and comfort.
Behavioral: Infant Massage Group
Routine clinical management provided to preterm infants in the NICU, including standard medical treatment, feeding, positioning, and hygiene care according to the unit's protocols.
The intervention involves a standardized infant massage therapy protocol applied by a trained researcher. The massage consists of gentle tactile stimulation targeting the upper and lower extremities to facilitate lymphatic drainage. The sessions are conducted for 15 minutes, once daily, for a period of 14 consecutive days. This intervention is provided in addition to standard NICU care.
Change in Extremity Circumference
Circumference measurements of the upper and lower extremities (specifically the wrist, elbow, ankle, and knee) will be taken using a non-elastic tape measure. Measurements are recorded in centimeters to assess the reduction of fluid accumulation. A decrease in circumference indicates improvement in lymphedema symptoms.
Time frame: Baseline (Day 0), Day 7, and Day 14
Change in Pitting Edema Grade
Pitting edema severity is assessed by applying gentle pressure to the edematous area for 5 seconds and observing the depth and duration of the indentation (pitting). It is graded on a standard clinical scale (e.g., +1 to +4), where higher scores indicate more severe edema and lower scores indicate improvement.
Time frame: Baseline (Day 0), Day 7, and Day 14
Change in Comfort Level (Premature Infant Comfort Scale)
Neonatal comfort is assessed using the Premature Infant Comfort Scale. The scale consists of 7 items, each scored from 1 to 5. The total score ranges from 7 to 35. A score of 35 indicates the lowest level of comfort (highest distress), while a score of 7 indicates the highest level of comfort. Higher scores indicate lower comfort levels (worse outcome).
Time frame: Baseline (Day 0), Day 7, and Day 14 (Assessed before and after the intervention)
Change in Heart Rate
Heart rate is monitored to evaluate the infant's physiological response to the massage. It is measured in beats per minute (bpm).
Time frame: Baseline (Day 0), Day 7, and Day 14 (Measured before, during, and after intervention)
Change in Oxygen Saturation
Oxygen saturation levels are monitored to assess respiratory stability and physiological comfort. It is measured as a percentage (SpO2 %).
Time frame: Baseline (Day 0), Day 7, and Day 14 (Measured before, during, and after intervention)
Change in Body Temperature
Body temperature is recorded to monitor thermoregulation during the massage application. It is measured in degrees Celsius (°C).
Time frame: Baseline (Day 0), Day 7, and Day 14 (Measured before, during, and after intervention)
No study locations are listed for this record.
Plan to share: No — Individual participant data will not be shared due to privacy laws and ethical restrictions.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Erzurum Technical University