Abdominal Massage for Newborn Jaundice
ConditionNeonatal Jaundice
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-1
SponsorYueh-Chu Peng
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Infant Abdominal Massage
Other interventionInfant 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 interventionNewborns 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.
Treatment groups
84 Participants
are divided into 2 treatment groupsGroup A: Abdominal Massage GroupExperimental treatment 1 intervention
Group B: Routine Care GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Transcutaneous Bilirubin Levels
Transcutaneous bilirubin (TcB) levels will be measured in mg/dL on the newborn's forehead using a PHILIPS BiliChek transcutaneous bilirubin meter. Measurements will be obtained at 0-6 hours, 24±2 hours, 48±2 hours, 72±4 hours, 96±4 hours, and 120±4 hours after birth. Changes in TcB levels over time will be compared between the abdominal massage group and the routine care group.
Time frame
At 0-6, 24±2, 48±2, 72±4, 96±4, and 120±4 hours after birthSecondary outcomes
1
Number of Bowel Movements
The total number of bowel movements will be recorded during each 24-hour period. Stool characteristics will also be classified as meconium, yellow stool, watery stool, or other. The number of bowel movements will be compared between the two study groups.
Time frame
Daily from birth through 120 hours after birth2
Time to First Bowel Movement
The time from birth to the newborn's first bowel movement will be recorded in hours. The date, time, and characteristics of the first stool will also be documented.
Time frame
From birth until the first bowel movement, up to 120 hours after birth3
Number of Breastfeeding Sessions
The number of breastfeeding sessions will be recorded during each 24-hour period. Feeding type will be classified as exclusive breastfeeding, mixed feeding, or formula feeding.
Time frame
Daily from birth through 120 hours after birth4
Number of Formula-Feeding Sessions
The number of formula-feeding sessions will be recorded during each 24-hour period.
Time frame
Daily from birth through 120 hours after birthOther outcomes
1
Total Serum Bilirubin Level
Total serum bilirubin (TSB) levels will be measured in mg/dL according to routine clinical practice when the transcutaneous bilirubin level approaches the treatment threshold, when ordered by a physician, or when otherwise clinically indicated.
Time frame
From birth through 120 hours after birth, when clinically indicatedSponsors and contacts
Click on the lead sponsor to view all of their trials.
Yueh-Chu Peng
Lead sponsor
Taichung Veterans General Hospital
Sponsor institution
Taichung Veterans General Hospital
Collaborator
Source ClinicalTrials.gov