Effects of Infant Abdominal Massage on Neonatal Jaundice: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Change in Transcutaneous Bilirubin Levels
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
The data analyst will be masked to group assignment. Group labels will be coded as Group 1 and Group 2, and the allocation code will not be revealed until the primary statistical analyses are completed.
入排标准
- 年龄范围
- 0 Days 至 1 Day（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Abdominal Massage Group
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.
干预措施: Infant Abdominal Massage (Other)
Routine Care Group
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.
干预措施: Routine Newborn Care (Other)
结局指标
主要结局
Change in Transcutaneous Bilirubin Levels
时间窗: At 0-6, 24±2, 48±2, 72±4, 96±4, and 120±4 hours after birth
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.
次要结局
- Number of Bowel Movements(Daily from birth through 120 hours after birth)
- Time to First Bowel Movement(From birth until the first bowel movement, up to 120 hours after birth)
- Number of Breastfeeding Sessions(Daily from birth through 120 hours after birth)
- Number of Formula-Feeding Sessions(Daily from birth through 120 hours after birth)
- Amount of Formula Intake(Daily from birth through 120 hours after birth)
- Number of Diaper Changes(Daily from birth through 120 hours after birth)
- Change in Newborn Body Weight(Daily from birth through 120 hours after birth)
- Incidence of Phototherapy(From birth until hospital discharge, up to 5 days)
- Duration of Phototherapy(From initiation to completion of phototherapy during hospitalization, up to 5 days)
- Length of Hospital Stay(From birth until hospital discharge, up to 5 days)
- Jaundice-Related Outpatient Visit(Within 7 days after hospital discharge)
- Jaundice-Related Hospital Readmission(Within 7 days after hospital discharge)
研究者
Yueh-Chu Peng
Nurse Manager
Taichung Veterans General Hospital