Newborn Abdominal Massage to Prevent Hyperbilirubinemia

Not Applicable

Active, not recruiting

• Conditions: Newborn Jaundice
• Interventions: Procedure: Abdominal massage; Other: Reading

• Registration Number: NCT05282394
• Lead Sponsor: University of California, Davis

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-14
• Study First Submitted QC: 2022-03-07
• Study First Posted: 2022-03-16
• Study Start: 2022-08-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-27
• Last Update Posted: 2025-03-28
• Primary Completion: 2025-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Massage Intervention	Abdominal massage	Families will be instructed to provide parent-provided newborn abdominal massage three times per day through 5 days of life
Attention Control Intervention	Reading	Families will be provided with information about reading with baby.

Primary Outcome Measures

Name	Time	Method
Acceptability of the newborn massage intervention	Through study completion, up to one year	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%.
Feasibility of recruitment	Ascertained following completion of recruitment of 30 study participants. Through study completion, up to an average of one year.	Feasibility of recruitment will be defined by at least 30% of approached, eligible participants consenting to participate.

Secondary Outcome Measures

Name	Time	Method
Proportion of participants who read with baby in the last week	1-2 week survey	Proportion of participants who read with baby in the last week assessed by survey
Timing of first transitional (non-meconium) stool passage	Ascertained at 1-2 week survey
Parental satisfaction with newborn massage	7-14 day survey	Parental satisfaction with newborn massage assessed by survey
Proportion of participants who read with baby in the last 24 hours	1-2 week survey	Proportion of participants who read with baby in the last 24 hours assessed by survey
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	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)
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
Breastfeeding at 1 week of age	1-2 week survey	Infant received any human milk in the prior 24 hours

Trial Locations

Locations (1)

University of California-Davis; 🇺🇸 Sacramento, California, United States