Neonatal JaundiceNCT07747220
Abdominal Massage for Newborn Jaundice
A study testing Infant Abdominal Massage and Routine Newborn Care in people with Neonatal Jaundice, run by Yueh-Chu Peng at 1 site in Taiwan.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 0 days to 1 dayHealthy volunteers can take part
- Conditions the study is for
- Neonatal Jaundice
- What is being tested?
- Infant Abdominal Massage and Routine Newborn Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Aug 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days to 1 day
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
1650 Taiwan Boulevard Sect. 4
Taichung, Taiwan, 407219
Yueh-Chu Peng, PhD, RN, 886-4-23592525 ext. 8076, yjpeng1978@gmail.com
About this study
Official title: Effects of Infant Abdominal Massage on Neonatal Jaundice: A Randomized Controlled 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:
Read more
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.
Read the detailed description
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.
- Conditions
- Neonatal Jaundice
- Being tested
- Infant Abdominal Massage, Routine Newborn Care
- Keywords
- Infant Abdominal Massage, Neonatal Jaundice, Transcutaneous Bilirubin, Full-Term Newborns
- Medical subject headings
- Jaundice, Neonatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant Abdominal MassageOther
Also called Neonatal Abdominal Massage
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 CareOther
Also called Standard Newborn Care
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.
| Study group | Role | What they receive |
|---|---|---|
| Abdominal Massage Group | Experimental | 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. Receives: Other: Infant Abdominal Massage |
| Routine Care Group | Active comparator | 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. Receives: Other: Routine Newborn Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 0-6, 24±2, 48±2, 72±4, 96±4, and 120±4 hours after birth
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Within 7 days after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start11 Aug 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Neonatal JaundiceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 ratio to two parallel groups: routine newborn care plus abdominal massage or routine newborn care alone. Participants will remain in their assigned group throughout the study, with no crossover between interventions.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yueh-Chu Peng
- Sponsor type
- University, hospital or other
- Collaborators
- Taichung Veterans General Hospital
- Responsible party
- Sponsor-investigator, Yueh-Chu Peng, Taichung Veterans General Hospital
- Investigators
- Yueh-Chu Peng, PhD, RN, Principal investigator, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07747220
- Sponsor's protocol ID
- CF26476B
- Status last verified
- Sep 2026
- First submitted
- 31 Jul 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Shahbazi M, Khazaei S, Moslehi S, Shahbazi F. Effect of Massage Therapy for the Treatment of Neonatal Jaundice: A Systematic Review and Dose-Response Meta-analysis. Int J Pediatr. 2022 Mar 20;2022:9161074. doi: 10.1155/2022/9161074. eCollection 2022.
PubMed 35356100Kose S, Gozen D, Karadag Aytemiz OE, Caglayan S. The Effect of Abdominal Massage on Bilirubin Levels in Term Infants Receiving Phototherapy: A Randomized Controlled Trial. Adv Neonatal Care. 2024 Jun 1;24(3):E40-E46. doi: 10.1097/ANC.0000000000001149. Epub 2024 May 30.
PubMed 38815281Gozen D, Yilmaz OE, Dur S, Caglayan S, Tastekin A. Transcutaneous bilirubin levels of newborn infants performed abdominal massage: A randomized controlled trial. J Spec Pediatr Nurs. 2019 Apr;24(2):e12237. doi: 10.1111/jspn.12237. Epub 2019 Feb 28.
PubMed 30817090Chen J, Sadakata M, Ishida M, Sekizuka N, Sayama M. Baby massage ameliorates neonatal jaundice in full-term newborn infants. Tohoku J Exp Med. 2011 Feb;223(2):97-102. doi: 10.1620/tjem.223.97.
PubMed 21263210
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Infant Abdominal Massage on Neonatal Jaundice: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07747220
- Acronym / sponsor ID
- CF26476B
- Conditions
- Neonatal Jaundice
- Keywords
- Infant Abdominal Massage, Neonatal Jaundice, Transcutaneous Bilirubin, Full-Term Newborns
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Yueh-Chu PengUniversity, hospital or other
- Collaborators
- Taichung Veterans General Hospital
- Study start
- 11 Aug 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 5 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to two parallel groups: routine newborn care plus abdominal massage or routine newborn care alone. Participants will remain in their assigned group throughout the study, with no crossover between interventions.
| Arm | Type | Receives |
|---|---|---|
| Abdominal Massage Group | Experimental | Other: Infant Abdominal MassageNewborns 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. |
| Routine Care Group | Active comparator | Other: Routine Newborn CareNewborns 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. |
Who may qualify
- Ages
- 0 days to 1 day
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infant Abdominal MassageAlso: Neonatal Abdominal MassageInfant 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. | Other | Abdominal Massage Group |
| Routine Newborn CareAlso: Standard Newborn CareNewborns 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. | Other | Routine Care Group |
Primary outcome
Change in Transcutaneous Bilirubin Levels
Time frame: 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.
12 secondary outcomes
Number of Bowel Movements
Time frame: Daily from birth through 120 hours after birth
Time to First Bowel Movement
Time frame: From birth until the first bowel movement, up to 120 hours after birth
Number of Breastfeeding Sessions
Time frame: Daily from birth through 120 hours after birth
Number of Formula-Feeding Sessions
Time frame: Daily from birth through 120 hours after birth
Amount of Formula Intake
Time frame: Daily from birth through 120 hours after birth
Number of Diaper Changes
Time frame: Daily from birth through 120 hours after birth
Change in Newborn Body Weight
Time frame: Daily from birth through 120 hours after birth
Incidence of Phototherapy
Time frame: From birth until hospital discharge, up to 5 days
Duration of Phototherapy
Time frame: From initiation to completion of phototherapy during hospitalization, up to 5 days
Length of Hospital Stay
Time frame: From birth until hospital discharge, up to 5 days
Jaundice-Related Outpatient Visit
Time frame: Within 7 days after hospital discharge
Jaundice-Related Hospital Readmission
Time frame: Within 7 days after hospital discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Results publication: PubMed 35356100Shahbazi M, Khazaei S, Moslehi S, Shahbazi F. Effect of Massage Therapy for the Treatment of Neonatal Jaundice: A Systematic Review and Dose-Response Meta-analysis. Int J Pediatr. 2022 Mar 20;2022:9161074. doi: 10.1155/2022/9161074. eCollection 2022.
- Results publication: PubMed 38815281Kose S, Gozen D, Karadag Aytemiz OE, Caglayan S. The Effect of Abdominal Massage on Bilirubin Levels in Term Infants Receiving Phototherapy: A Randomized Controlled Trial. Adv Neonatal Care. 2024 Jun 1;24(3):E40-E46. doi: 10.1097/ANC.0000000000001149. Epub 2024 May 30.
- Results publication: PubMed 30817090Gozen D, Yilmaz OE, Dur S, Caglayan S, Tastekin A. Transcutaneous bilirubin levels of newborn infants performed abdominal massage: A randomized controlled trial. J Spec Pediatr Nurs. 2019 Apr;24(2):e12237. doi: 10.1111/jspn.12237. Epub 2019 Feb 28.
- Results publication: PubMed 21263210Chen J, Sadakata M, Ishida M, Sekizuka N, Sayama M. Baby massage ameliorates neonatal jaundice in full-term newborn infants. Tohoku J Exp Med. 2011 Feb;223(2):97-102. doi: 10.1620/tjem.223.97.
- Individual participant dataSharing planned: 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.
Related trials for Neonatal Jaundice
Active, not recruiting
Newborn Abdominal Massage to Prevent Hyperbilirubinemia
Newborn Jaundice
Not yet recruiting
Efficacy of Bifidobacterium Animalis Subsp. Lactis in the Treatment of Indirect Hyperbilirubinemia in Term Neonates
Indirect Hyperbilirubinemia
Not yet recruitingPhase 4
Comparison Of Fenofibrate Vs Phenobarbitone As Adjunct To Phototherapy In Reducing Total Serum Bilirubin In Indirect Hyperbilirubinemia In Neonates
Jaundice, Neonatal
Enrolling by invitation
Hat-Type Glasses Intervention in Phototherapy-Related Newborns
Neonatal Hyperbilirubinemia, Neonatal Jaundice
Not yet recruitingObservational study
Predictors of Rebound Hyperbilirubinemia Study
Neonatal Hyperbilirubinemia, Rebound Hyperbilirubinemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yueh-Chu Peng, PhD, RN principal investigator
Taichung Veterans General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infant Abdominal Massage and Routine Newborn Care in people with Neonatal Jaundice, run by Yueh-Chu Peng at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yueh-Chu Peng, PhD, RN (886-4-23592525 ext. 8076, yjpeng1978@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Transcutaneous Bilirubin Levels (time frame: At 0-6, 24±2, 48±2, 72±4, 96±4, and 120±4 hours after birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07747220, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.