Newborn Abdominal Massage to Prevent Hyperbilirubinemia

NCT05282394 | Active Not Recruiting

• 2 other identifiers: 1817729K12HD051958
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Newborn Jaundice

Keywords

newborn massage

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Difference between transcutaneous bilirubin level and AAP phototherapy threshold on the day of discharge

  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

  7-14 day survey

• Proportion of participants who read with baby in the last 24 hours

  1-2 week survey

Study Arms (2)

Massage Intervention

EXPERIMENTAL

Families will be instructed to provide parent-provided newborn abdominal massage three times per day through 5 days of life

Procedure: Abdominal massage

Attention Control Intervention

OTHER

Families will be provided with information about reading with baby.

Other: Reading

Interventions

Abdominal massage PROCEDURE

abdominal massage

Massage Intervention

Reading OTHER

guidance given to parents about reading with baby

Attention Control Intervention

Eligibility Criteria

• Age: 0 Hours - 48 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead
• National Institutes of Health (NIH): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of California-Davis

Sacramento, California, 95817, United States

Location

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

• Laura Kair, MD, MAS

  UC Davis Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2021
• First Posted: March 16, 2022
• Study Start: August 1, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 19, 2025

Record last verified: 2025-09

Locations

US (1)