Abdominal Massage for Newborn Jaundice

NCT07747220 | Recruiting

• 1 other identifier: CF26476B
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Neonatal Jaundice

Keywords

Infant Abdominal Massage; Neonatal Jaundice; Transcutaneous Bilirubin; Full-Term Newborns

Outcome Measures

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.

  At 0-6, 24±2, 48±2, 72±4, 96±4, and 120±4 hours after birth

Secondary Outcomes (12)

• 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

Other Outcomes (1)

• Total Serum Bilirubin Level

  From birth through 120 hours after birth, when clinically indicated

Study Arms (2)

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.

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.

Other: Routine Newborn Care

Interventions

Infant Abdominal Massage OTHER

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

Abdominal Massage Group

Routine Newborn Care OTHER

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

Routine Care Group

Eligibility Criteria

• Age: 0 Days - 1 Day
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yueh-Chu Peng: lead
• Taichung Veterans General Hospital: collaborator

Study Sites (1)

1650 Taiwan Boulevard Sect. 4

Taichung, Taiwan, 407219, Taiwan

RECRUITING

Related Publications (4)

• 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.

  PMID: 35356100 RESULT

• Kose 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.

  PMID: 38815281 RESULT

• Gozen 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.

  PMID: 30817090 RESULT

• Chen 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.

  PMID: 21263210 RESULT

MeSH Terms

Conditions

Jaundice, Neonatal

Condition Hierarchy (Ancestors)

Hyperbilirubinemia, Neonatal; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yueh-Chu Peng, PhD, RN

  Taichung Veterans General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yueh-Chu Peng, PhD, RN

CONTACT

886-4-23592525; yjpeng1978@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Nurse Manager

Model Details: 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.

Study Record Dates

• First Submitted: July 31, 2026
• First Posted: August 5, 2026
• Study Start: August 11, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)