Newborn Abdominal Massage to Prevent Hyperbilirubinemia

Newborn Abdominal Massage to Prevent Hyperbilirubinemia: A Pilot Randomized Controlled Trial

The proposed study will incorporate an intervention previously un-studied in the US healthcare setting for prevention of hyperbilirubinemia

Study Overview

• Status: Active, not recruiting
• Conditions: Newborn Jaundice
• Intervention / Treatment: Procedure: Abdominal massage; Other: Reading

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • University of California-Davis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 2 days (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Newborn admitted to the well newborn/postpartum care unit at UC Davis Medical Center
• Less than 48 hours of age at enrollment

Exclusion Criteria:

• Infant has already received phototherapy
• Mother/birthing person is incarcerated
• Infant unexpected to discharge into parental care
• Parental inability to speak or read in English
• Infant without parent rooming-in with them in the hospital

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Massage Intervention; Families will be instructed to provide parent-provided newborn abdominal massage three times per day through 5 days of life	Procedure: Abdominal massage; abdominal massage
Other: Attention Control Intervention; Families will be provided with information about reading with baby.	Other: Reading; guidance given to parents about reading with baby

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of the newborn massage intervention	Acceptability of the intervention will be defined by the 1-sided 95% confidence interval for the proportion of the intervention group performing massage at least once to include 80% and for the 1-sided 95% confidence interval for at the proportion performing massage as directed to include 70%.	Through study completion, up to one year
Feasibility of recruitment	Feasibility of recruitment will be defined by at least 30% of approached, eligible participants consenting to participate.	Ascertained following completion of recruitment of 30 study participants. Through study completion, up to an average of one year.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference between transcutaneous bilirubin level and AAP phototherapy threshold on the day of discharge	delta-TcSB, which is calculated by subtracting infant's transcutaneous bilirubin level from their phototherapy treatment threshold at that hour of age (in mg/dL)	Value at obtained at hospital discharge will be evaluated at the end of study completion, up to one year
Number of stools in prior 24 hours (at hospital discharge)		Value at obtained at hospital discharge will be evaluated at the end of study completion, up to one year
Timing of first transitional (non-meconium) stool passage		Ascertained at 1-2 week survey
Parental satisfaction with newborn massage	Parental satisfaction with newborn massage assessed by survey	7-14 day survey
Proportion of participants who read with baby in the last 24 hours	Proportion of participants who read with baby in the last 24 hours assessed by survey	1-2 week survey
Proportion of participants who read with baby in the last week	Proportion of participants who read with baby in the last week assessed by survey	1-2 week survey
Breastfeeding at 1 week of age	Infant received any human milk in the prior 24 hours	1-2 week survey

Collaborators and Investigators

• Sponsor: University of California, Davis
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Laura Kair, MD, MAS, UC Davis Health

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: December 14, 2021
• First Submitted That Met QC Criteria: March 7, 2022
• First Posted (Actual): March 16, 2022

Study Record Updates

• Last Update Posted (Estimated): September 19, 2025
• Last Update Submitted That Met QC Criteria: September 18, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: newborn massage
• Additional Relevant MeSH Terms: Pathologic Processes; Infant, Newborn, Diseases; Hyperbilirubinemia; Hyperbilirubinemia, Neonatal; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Jaundice, Neonatal
• Other Study ID Numbers: 1817729; K12HD051958 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No