Abdominal Massage for Newborn Jaundice

Overseen By Iesha Miller, MHA

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Davis

Disqualifiers: Phototherapy, Incarceration, Parental care, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Research Team

Laura Kair, MD, MAS

Principal Investigator

UC Davis Health

Eligibility Criteria

This trial is for newborns under 48 hours old in the well newborn/postpartum unit at UC Davis Medical Center. It's not for babies who've had phototherapy, whose mothers are incarcerated, who aren't going into parental care after discharge, or if parents can't read or speak English.

Inclusion Criteria

I am enrolling my newborn who is less than 2 days old.

Newborn admitted to the well newborn/postpartum care unit at UC Davis Medical Center

Exclusion Criteria

Parental inability to speak or read in English

My infant is in the hospital without me staying in the same room.

My infant has undergone phototherapy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Families provide newborn abdominal massage three times per day through 5 days of life

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

Study Completion

Final assessments and data collection for primary and secondary outcomes

Up to one year

Treatment Details

Interventions

• Abdominal massage

Trial Overview The study tests abdominal massage as a new method to prevent high bilirubin levels (hyperbilirubinemia) that cause jaundice in newborns. The effectiveness of this technique will be compared with reading to the infant.

Participant Groups

Group I: Massage Intervention Experimental Treatment 1 Intervention

Families will be instructed to provide parent-provided newborn abdominal massage three times per day through 5 days of life

Group II: Attention Control Intervention Experimental Treatment 1 Intervention

Families will be provided with information about reading with baby.

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+