Newborn Abdominal Massage to Prevent Hyperbilirubinemia

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

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

Conditions
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Newborn Jaundice

Intervention / Treatment
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* Procedure: Abdominal massage
* Other: Reading


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 0 Hours
Maximum Age: 48 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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newborn massage