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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether abdominal massage can prevent jaundice in newborns, a condition where excess bilirubin in the blood turns the skin and eyes yellow. It compares babies who receive the massage with those who only receive information about reading with their baby. Newborns less than 48 hours old at the UC Davis Medical Center, who have not undergone phototherapy, may qualify. The study aims to determine if a simple massage can be a helpful new method to keep babies healthy. As an unphased trial, it offers a unique opportunity to explore innovative, non-invasive methods for newborn care.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that abdominal massage is safe for newborns?

Research has shown that abdominal massage is generally safe and may help with newborn jaundice. Studies have found that this type of massage can lower bilirubin levels, which is important because high bilirubin causes jaundice. It can also help babies have more frequent bowel movements, aiding in the removal of excess bilirubin.

No reports of serious side effects from abdominal massage exist. Since this treatment mainly involves gently rubbing the baby's belly, it is usually well-tolerated, meaning most babies can handle it without any problems.

For those considering joining this trial, previous research suggests promising safety evidence for abdominal massage. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for newborn jaundice, which often involve phototherapy or, in severe cases, blood transfusions, abdominal massage is a non-invasive and gentle approach. Researchers are excited about this method because it empowers parents to actively participate in their newborn's care, potentially improving family bonding while addressing the condition. This technique might also offer a cost-effective and accessible alternative to more traditional treatments, which can be resource-intensive and require hospital stays.

What evidence suggests that abdominal massage is effective for newborn jaundice?

Research has shown that a gentle belly massage for newborns can help lower their bilirubin levels. Bilirubin is a substance that can cause jaundice, giving a baby's skin a yellow appearance. One study found that massage therapy significantly reduced bilirubin levels in both the blood and skin. Another study found that belly massage not only lowered bilirubin levels but also increased bowel movements, aiding in bilirubin removal from the body. This trial will evaluate the effectiveness of parent-provided newborn abdominal massage, performed by participants in the massage intervention arm three times per day through the first 5 days of life. Overall, these findings suggest that belly massage could effectively manage jaundice in newborns. ^{1 3 4 6 7}

Who Is on the Research Team?

Laura Kair, MD, MAS

Principal Investigator

UC Davis Health

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1355184119301255

Massage therapy for the treatment of neonatal jaundice Massage therapy improves neonatal jaundice by either reducing enterohepatic bilirubin cycle or inhibiting its production.

2. withpower.com withpower.com/trial/phase-newborn-jaundice-4-2022-aba3c

Abdominal Massage for Newborn Jaundice Trial Overview The study tests abdominal massage as a new method to prevent high bilirubin levels (hyperbilirubinemia) that cause jaundice in newborns. The ...

3. mdpi.com mdpi.com/1660-4601/19/11/6378

Effects of Infant Massage: A Systematic Review Infant massage can counteract jaundice in newborns. Children with jaundice showed improved bilirubin levels as a result of infant massage ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8958079/

Effect of Massage Therapy for the Treatment of Neonatal ... in 2018, massage therapy can significantly decrease serum and transcutaneous bilirubin levels [25]. In this updated systematic review, we aimed ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38815281/

The Effect of Abdominal Massage on Bilirubin Levels in ... Implication for practice and research: Abdominal massage was effective in reducing bilirubin levels and may increase the number of defecations.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6626238/

Effects of massage on newborn infants with jaundice Massage can decrease serum total bilirubin and percutaneous bilirubin levels and increasing defecation frequency.

7. ijponline.biomedcentral.com ijponline.biomedcentral.com/articles/10.1186/s13052-015-0202-y

Effects of infant massage on jaundiced neonates undergoing ... Infant massage could help to reduce bilirubin levels and increase defecation frequency in neonates receiving phototherapy for jaundice.