Newborn JaundiceNCT05282394
Newborn Abdominal Massage to Prevent Hyperbilirubinemia
A study testing Abdominal massage and Reading in people with Newborn Jaundice, run by University of California, Davis at 1 site in United States.
Trial summary
The proposed study will incorporate an intervention previously un-studied in the US healthcare setting for prevention of hyperbilirubinemia Read more about this study
- Who is it for?
- Ages 0 to 48 hoursHealthy volunteers can take part
- Conditions the study is for
- Newborn Jaundice
- What is being tested?
- Abdominal massage and Reading
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2022to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 48 hours
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Newborn admitted to the well newborn/postpartum care unit at UC Davis Medical Center
- Less than 48 hours of age at enrollment
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California-Davis
Sacramento, California, 95817
About this study
Official title: Newborn Abdominal Massage to Prevent Hyperbilirubinemia: A Pilot Randomized Controlled Trial
The proposed study will incorporate an intervention previously un-studied in the US healthcare setting for prevention of hyperbilirubinemia
- Conditions
- Newborn Jaundice
- Being tested
- Abdominal massage, Reading
- Keywords
- newborn massage
- Medical subject headings
- Jaundice, Neonatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal massageProcedure or surgery
abdominal massage
ReadingOther
guidance given to parents about reading with baby
| Study group | Role | What they receive |
|---|---|---|
| Massage Intervention | Experimental | Families will be instructed to provide parent-provided newborn abdominal massage three times per day through 5 days of life Receives: Procedure: Abdominal massage |
| Attention Control Intervention | Other | Families will be provided with information about reading with baby. Receives: Other: Reading |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 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.
Measured: Ascertained following completion of recruitment of 30 study participants. Through study completion, up to an average of one year.
Secondary outcomes (7)
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)
Measured: 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)
Measured: 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
Measured: Ascertained at 1-2 week survey
Parental satisfaction with newborn massage
Parental satisfaction with newborn massage assessed by survey
Measured: 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
Measured: 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
Measured: 1-2 week survey
Breastfeeding at 1 week of age
Infant received any human milk in the prior 24 hours
Measured: 1-2 week survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start1 Aug 2022
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newborn JaundiceStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Laura Kair, MD, MAS, Principal investigator, UC Davis Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05282394
- Sponsor's protocol ID
- 1817729
- Other IDs
- K12HD051958
- Status last verified
- Sep 2026
- First submitted
- 14 Dec 2021
- Last updated
- 22 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Newborn Abdominal Massage to Prevent Hyperbilirubinemia: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05282394
- Acronym / sponsor ID
- 1817729
- Conditions
- Newborn Jaundice
- Keywords
- newborn massage
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 16 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed study will incorporate an intervention previously un-studied in the US healthcare setting for prevention of hyperbilirubinemia
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Massage Intervention | Experimental | Procedure: Abdominal massageFamilies will be instructed to provide parent-provided newborn abdominal massage three times per day through 5 days of life |
| Attention Control Intervention | Other | Other: ReadingFamilies will be provided with information about reading with baby. |
Who may qualify
- Ages
- 0 to 48 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Newborn admitted to the well newborn/postpartum care unit at UC Davis Medical Center
- Less than 48 hours of age at enrollment
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abdominal massageabdominal massage | Procedure or surgery | Massage Intervention |
| Readingguidance given to parents about reading with baby | Other | Attention Control Intervention |
Primary outcome
Acceptability of the newborn massage intervention
Time frame: 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
Time frame: 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.
7 secondary outcomes
Difference between transcutaneous bilirubin level and AAP phototherapy threshold on the day of discharge
Time frame: 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)
Time frame: 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
Time frame: Ascertained at 1-2 week survey
Parental satisfaction with newborn massage
Time frame: 7-14 day survey
Proportion of participants who read with baby in the last 24 hours
Time frame: 1-2 week survey
Proportion of participants who read with baby in the last week
Time frame: 1-2 week survey
Breastfeeding at 1 week of age
Time frame: 1-2 week survey
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
Related trials for Newborn Jaundice
Recruiting
Abdominal Massage for Newborn Jaundice
Neonatal Jaundice
Not yet recruiting
Efficacy of Bifidobacterium Animalis Subsp. Lactis in the Treatment of Indirect Hyperbilirubinemia in Term Neonates
Indirect Hyperbilirubinemia
Not yet recruitingPhase 4
Comparison Of Fenofibrate Vs Phenobarbitone As Adjunct To Phototherapy In Reducing Total Serum Bilirubin In Indirect Hyperbilirubinemia In Neonates
Jaundice, Neonatal
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Hat-Type Glasses Intervention in Phototherapy-Related Newborns
Neonatal Hyperbilirubinemia, Neonatal Jaundice
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Predictors of Rebound Hyperbilirubinemia Study
Neonatal Hyperbilirubinemia, Rebound Hyperbilirubinemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Kair, MD, MAS principal investigator
UC Davis Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abdominal massage and Reading in people with Newborn Jaundice, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of the newborn massage intervention (time frame: Through study completion, up to one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.