Newborn Jaundice
Conditions
Keywords
newborn massage
Brief summary
The proposed study will incorporate an intervention previously un-studied in the US healthcare setting for prevention of hyperbilirubinemia
Interventions
PROCEDUREAbdominal massage
abdominal massage
OTHERReading
guidance given to parents about reading with baby
Sponsors
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of California, Davis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Hours to 48 Hours
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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) |
| 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 |
| Breastfeeding at 1 week of age | 1-2 week survey | Infant received any human milk in the prior 24 hours |
| 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 |
| 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 | — |
Countries
United States
Outcome results
None listed