Newborn Abdominal Massage to Prevent Hyperbilirubinemia

NCT ID: NCT05282394

Last Updated: 2025-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2026-06-30

Brief Summary

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

Detailed Description

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Conditions

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Newborn Jaundice

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Massage Intervention

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

Group Type EXPERIMENTAL

Abdominal massage

Intervention Type PROCEDURE

abdominal massage

Attention Control Intervention

Families will be provided with information about reading with baby.

Group Type OTHER

Reading

Intervention Type OTHER

guidance given to parents about reading with baby

Interventions

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Abdominal massage

abdominal massage

Intervention Type PROCEDURE

Reading

guidance given to parents about reading with baby

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

0 Hours

Maximum Eligible Age

48 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

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

NIH

Sponsor Role collaborator

University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laura Kair, MD, MAS

Role: PRINCIPAL_INVESTIGATOR

UC Davis Health

Locations

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University of California-Davis

Sacramento, California, United States

Site Status

Countries

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United States

Other Identifiers

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K12HD051958

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1817729

Identifier Type: -

Identifier Source: org_study_id

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