An interventional study of Infant Abdominal Massage and Routine Newborn Care in Neonatal Jaundice, sponsored by Yueh-Chu Peng. Recruiting at 1 site in Taiwan. Open to participants aged 0 Days to 1 Day, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by Yueh-Chu Peng · Not applicable, Interventional, and Prevention
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.
Neonatal jaundice is a common condition during the early postnatal period and is associated with immature bilirubin metabolism, increased red blood cell breakdown, limited hepatic conjugation and excretion, and increased enterohepatic circulation. Although most cases are physiologic, markedly elevated bilirubin levels may lead to serious neurologic complications if not identified and treated promptly. Standard newborn care therefore includes jaundice assessment, feeding support, bilirubin monitoring, and phototherapy when clinically indicated.
Abdominal massage is a non-pharmacological and non-invasive nursing intervention that may stimulate intestinal motility, increase stool passage, promote meconium excretion, and reduce intestinal reabsorption of bilirubin. Previous studies have suggested that infant massage may lower bilirubin levels and increase stool frequency; however, evidence from standardized clinical protocols in healthy full-term newborns remains limited. This study will evaluate the effectiveness, feasibility, and safety of a standardized abdominal massage intervention for neonatal jaundice.
This study is a two-arm, parallel-group randomized controlled trial. A total of 84 eligible full-term newborns will be randomly assigned in a 1:1 ratio to either an intervention group or a control group. Block randomization with a fixed block size of four will be used to maintain balanced enrollment between groups. Allocation concealment will be maintained using sequentially numbered, opaque, sealed envelopes prepared by a researcher who is not involved in participant recruitment, intervention delivery, or outcome measurement.
Because the abdominal massage procedure is readily identifiable, the nurses providing the intervention cannot be blinded. However, the nurses responsible for bilirubin measurement and data collection will not participate in randomization or massage delivery and will remain unaware of group assignment. Data analysis will also be conducted using coded group labels until the primary statistical analyses have been completed.
Both groups will receive the same routine newborn care, including feeding support, clinical observation for jaundice, transcutaneous or serum bilirubin assessment, phototherapy when medically indicated, and discharge education. The control group will not receive abdominal massage during the study period.
Newborns assigned to the intervention group will receive routine care plus standardized abdominal massage. The massage will be administered twice daily for 10 to 15 minutes during hospitalization for 2 to 5 days. It will begin after medical assessment confirms that the newborn is clinically stable and at least 1 hour after feeding. The newborn must be awake and calm before the intervention begins.
The standardized massage procedure includes gentle clockwise circular massage over the abdomen following the direction of intestinal movement, gentle flexion of the knees toward the abdomen, and light circular massage across the lower abdomen and groin area from right to left. Excessive pressure over the liver, spleen, or unhealed umbilical area will be avoided. The procedure will be performed by trained nurses who have completed infant massage education and standardized intervention training. Each session will be documented to monitor intervention fidelity.
Transcutaneous bilirubin will be measured on the forehead using a standardized bilirubin meter at approximately 0-6, 24, 48, 72, 96, and 120 hours after birth. If a transcutaneous bilirubin value approaches the clinical treatment threshold, total serum bilirubin will be measured according to routine clinical practice. Additional clinical data will include stool frequency, time to first stool passage, feeding frequency and amount, diaper frequency, daily weight change, use and duration of phototherapy, length of hospital stay, and adverse events. Medical records will also be reviewed for jaundice-related outpatient visits or readmissions within 7 days after discharge.
The primary analysis will evaluate differences in transcutaneous bilirubin trends over time between the two groups. Generalized estimating equations will be used to examine the effects of group, time, and the group-by-time interaction. Potential confounding variables, such as gestational age, birth weight, feeding method, delivery mode, percentage of weight loss, and baseline bilirubin level, may be included in adjusted analyses when necessary. Secondary outcomes will be analyzed using appropriate parametric, nonparametric, categorical, or regression methods according to the distribution and type of the data. All statistical tests will be two-sided, with statistical significance set at p \< 0.05.
Safety will be assessed before, during, and after each massage session. Nurses will observe skin color, respiratory pattern, crying, abdominal distension, vomiting, activity, feeding tolerance, and vital signs. Massage will be stopped immediately if the newborn develops persistent crying, vomiting, marked abdominal distension, skin changes, respiratory abnormalities, unstable vital signs, or any other sign of discomfort. A pediatrician will evaluate the newborn when clinically indicated. Any newborn who reaches the threshold for phototherapy or other treatment will receive standard medical care without delay, regardless of group assignment.
110 studies on the registry are indexed under Jaundice, Neonatal; 28 are open to participants now.
This study's planned enrollment of 84 is below the median of 150 across 78 interventional studies indexed under Jaundice, Neonatal.
Browse Jaundice, Neonatal studies →This is the only study on the registry with Yueh-Chu Peng as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
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.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
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.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Newborns assigned to this arm will receive routine newborn care plus standardized abdominal massage. The massage will be performed by trained nurses for 10 to 15 minutes per session, twice daily, during hospitalization for 2 to 5 days. Massage will be provided at least 1 hour after feeding while the newborn is awake, calm, and clinically stable. The procedure includes gentle clockwise abdominal massage, gentle flexion of the knees toward the abdomen, and light circular massage of the lower abdomen and groin area.
Other: Infant Abdominal Massage
Newborns assigned to this arm will receive routine newborn care, including feeding support, jaundice observation, transcutaneous or serum bilirubin measurement, phototherapy when clinically indicated, and discharge education. No abdominal massage will be provided during the study period.
Other: Routine Newborn Care
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.
Also known as: Neonatal Abdominal Massage
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.
Also known as: Standard Newborn Care
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 birth
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 birth
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 birth
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 birth
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 birth
Amount of Formula Intake
The total amount of formula consumed will be recorded in milliliters during each 24-hour period for newborns who receive formula or mixed feeding.
Time frame: Daily from birth through 120 hours after birth
Number of Diaper Changes
The total number of diaper changes will be recorded during each 24-hour period and compared between the two study groups.
Time frame: Daily from birth through 120 hours after birth
Change in Newborn Body Weight
Newborn body weight will be recorded in grams during each 24-hour period. Changes in body weight from birth will be calculated and compared between the abdominal massage group and the routine care group.
Time frame: Daily from birth through 120 hours after birth
Incidence of Phototherapy
The number and percentage of newborns who receive phototherapy during hospitalization will be recorded. Phototherapy will be initiated according to clinical treatment criteria or a physician's order.
Time frame: From birth until hospital discharge, up to 5 days
Duration of Phototherapy
For newborns who receive phototherapy, the total duration of phototherapy will be calculated in hours from the recorded start and end times.
Time frame: From initiation to completion of phototherapy during hospitalization, up to 5 days
Length of Hospital Stay
The total length of the newborn's hospital stay will be calculated in days from birth to hospital discharge.
Time frame: From birth until hospital discharge, up to 5 days
Jaundice-Related Outpatient Visit
Medical records will be reviewed to determine the number and percentage of newborns who return for an outpatient visit because of jaundice within 7 days after hospital discharge.
Time frame: Within 7 days after hospital discharge
Jaundice-Related Hospital Readmission
Medical records will be reviewed to determine the number and percentage of newborns who are readmitted to the hospital because of jaundice within 7 days after hospital discharge.
Time frame: Within 7 days after hospital discharge
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 indicated
Plan to share: No — Individual participant data will not be shared because the study involves newborns and includes sensitive maternal and neonatal clinical information. Study data will be used only for the purposes described in the approved research protocol and will be stored and managed in accordance with institutional and ethical requirements.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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