Newborn Abdominal Massage to Prevent Hyperbilirubinemia

N/AActive Not RecruitingNCT05282394

University of California, Davis30 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Newborn Jaundice

Interventions

Abdominal massagePROCEDURE

abdominal massage

ReadingOTHER

guidance given to parents about reading with baby

Eligibility

Sex: ALLMin age: 0 HoursMax age: 48 HoursHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of California-Davis

Sacramento, California, United States

Outcomes

Primary Outcomes

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%.

Time frame: 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.

Time frame: Ascertained following completion of recruitment of 30 study participants. Through study completion, up to an average of one year.

Secondary Outcomes

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)

Time frame: 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)

Time frame: 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

Time frame: Ascertained at 1-2 week survey

Parental satisfaction with newborn massage

Parental satisfaction with newborn massage assessed by survey

Time frame: 7-14 day survey

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

Data from ClinicalTrials.gov

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