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Infant Massage for Lymphedema and Comfort in Preterm Newborns

NCT07418814 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-02-18

No results posted yet for this study

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.

Conditions

  • Lymphedema
  • Premature Birth
  • Edema
  • Immobilization

Interventions

BEHAVIORAL

Infant Massage Group

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.

Sponsors & Collaborators

  • Erzurum Technical University

    lead OTHER

Principal Investigators

  • Ayşe Gürol, PhD · Erzurum Technical University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
28 Weeks
Max Age
37 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2026-06-30
Completion
2027-04-01

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07418814 on ClinicalTrials.gov