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RECRUITING Not applicable ClinicalTrials.gov

Abdominal Massage for Newborn Jaundice

Sponsor: Yueh-Chu Peng • ClinicalTrials.gov ID: NCT07747220

Registry updated: 2026-09-30
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Description

The goal of this clinical trial is to learn whether infant abdominal massage can help reduce bilirubin levels and improve bilirubin elimination in healthy full-term newborns. The study will include 84 newborns born at 37 weeks of gestation or later, with a birth weight of at least 2,500 grams, stable vital signs, and no major health problems. The main questions it aims to answer are: Does abdominal massage reduce transcutaneous bilirubin levels during the first 120 hours after birth? Does abdominal massage increase bowel movements or promote earlier passage of meconium? Does abdominal massage reduce the need for phototherapy, the duration of phototherapy, or the length of hospital stay? Is abdominal massage safe and feasible for full-term newborns? Researchers will compare newborns who receive routine newborn care plus abdominal massage with newborns who receive routine newborn care alone to determine whether abdominal massage improves bilirubin-related and clinical outcomes. Participants will: Be randomly assigned in a 1:1 ratio to either the abdominal massage group or the routine-care group. Receive routine newborn care, including feeding support, jaundice observation, bilirubin measurement, and phototherapy when clinically indicated. In the intervention group, receive gentle abdominal massage for 10 to 15 minutes twice daily during hospitalization for 2 to 5 days. Massage will begin at least 1 hour after feeding while the newborn is awake, calm, and medically stable. Have transcutaneous bilirubin measured at 0-6, 24, 48, 72, 96, and 120 hours after birth. A blood bilirubin test may be performed if the transcutaneous bilirubin level approaches the treatment threshold. Have information recorded about bowel movements, time of first bowel movement, feeding, diaper use, body weight, phototherapy, length of hospital stay, and any adverse events. Be followed through medical records for 7 days after discharge to determine whether the newborn returns for evaluation or is readmitted because of jaundice.

Interventions

  • Infant Abdominal Massage (Other)
    Infant abdominal massage will be performed by trained nurses twice daily for 10 to 15 minutes per session during hospitalization for 2 to 5 days. The massage will begin at least 1 hour after feeding while the newborn is awake, calm, and clinically stable. The standardized procedure includes gentle clockwise circular massage over the abdomen following the direction of intestinal movement, gentle flexion of the knees toward the abdomen 3 to 5 times, and light circular massage of the lower abdomen and groin area from right to left. The unhealed umbilical area will be avoided, and excessive pressure over the liver and spleen will not be applied. The newborn's skin color, respiratory pattern, crying, abdominal distension, vomiting, and vital signs will be monitored before, during, and after each session. Massage will be stopped immediately if any sign of discomfort or clinical instability occurs.
  • Routine Newborn Care (Other)
    Newborns assigned to this intervention will receive routine newborn care according to the hospital's standard clinical procedures. Care will include feeding support, clinical observation for jaundice, transcutaneous bilirubin measurement at scheduled time points, serum bilirubin measurement when clinically indicated, monitoring of body weight, feeding, urine output, and bowel movements, phototherapy when treatment criteria are met, and routine discharge education. No abdominal massage will be provided to newborns assigned to the routine care group during the study period.

Eligibility criteria

Inclusion Criteria: * Full-term newborns with a gestational age of 37 weeks or greater * Birth weight of 2,500 grams or greater * Apgar score of 7 or greater at 5 minutes after birth * Stable vital signs * No significant abnormal findings following examination by a physician after birth * Eligible to begin the study procedures at least 1 hour after the first feeding * Written informed consent provided by a parent or legal guardian Exclusion Criteria: * Preterm newborns or newborns with very low birth weight * Congenital gastrointestinal abnormalities, abdominal wall defects, or conditions requiring surgery * Major congenital diseases or chromosomal abnormalities * Admission to a neonatal intensive care unit * Sepsis, respiratory distress, or other acute or critical medical conditions * Pathologic jaundice, including hemolytic jaundice or biliary atresia * Bilirubin levels meeting the criteria for immediate phototherapy or exchange transfusion * Abdominal skin infection, skin damage, or any condition making abdominal massage unsuitable * Considered unsuitable for participation by the attending physician

Conditions

Neonatal Jaundice

Locations

  • 1650 Taiwan Boulevard Sect. 4 — Taichung, Taiwan, Taiwan
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record