Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| K12HD051958 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
The proposed study will incorporate an intervention previously un-studied in the US healthcare setting for prevention of hyperbilirubinemia
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Massage Intervention | Experimental | Families will be instructed to provide parent-provided newborn abdominal massage three times per day through 5 days of life |
|
| Attention Control Intervention | Other | Families will be provided with information about reading with baby. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abdominal massage | Procedure | abdominal massage |
| |
| 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. |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Laura Kair, MD, MAS | UC Davis Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California-Davis | Sacramento | California | 95817 | United States |
Not provided
| ID | Term |
|---|---|
| D007567 | Jaundice, Neonatal |
| ID | Term |
|---|---|
| D051556 | Hyperbilirubinemia, Neonatal |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006932 | Hyperbilirubinemia |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Reading |
| Other |
guidance given to parents about reading with baby |
|
| 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 |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |