Abdominal Massage for Newborn Jaundice

Overview

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.