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Newborn Abdominal Massage to Prevent Hyperbilirubinemia

Primary Purpose

Newborn Jaundice

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Abdominal massage
Reading
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Newborn Jaundice focused on measuring newborn massage

Eligibility Criteria

0 Hours - 48 Hours (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of California-DavisRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Massage Intervention

Attention Control Intervention

Arm Description

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

Families will be provided with information about reading with baby.

Outcomes

Primary Outcome Measures

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%.
Feasibility of recruitment
Feasibility of recruitment will be defined by at least 30% of approached, eligible participants consenting to participate.

Secondary Outcome Measures

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)
Number of stools in prior 24 hours (at hospital discharge)
Timing of first transitional (non-meconium) stool passage
Parental satisfaction with newborn massage
Parental satisfaction with newborn massage assessed by 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
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
Breastfeeding at 1 week of age
Infant received any human milk in the prior 24 hours

Full Information

First Posted
December 14, 2021
Last Updated
June 13, 2023
Sponsor
University of California, Davis
Collaborators
National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT05282394
Brief Title
Newborn Abdominal Massage to Prevent Hyperbilirubinemia
Official Title
Newborn Abdominal Massage to Prevent Hyperbilirubinemia: A Pilot Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
Collaborators
National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Newborn Jaundice
Keywords
newborn massage

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Massage Intervention
Arm Type
Experimental
Arm Description
Families will be instructed to provide parent-provided newborn abdominal massage three times per day through 5 days of life
Arm Title
Attention Control Intervention
Arm Type
Other
Arm Description
Families will be provided with information about reading with baby.
Intervention Type
Procedure
Intervention Name(s)
Abdominal massage
Intervention Description
abdominal massage
Intervention Type
Other
Intervention Name(s)
Reading
Intervention Description
guidance given to parents about reading with baby
Primary Outcome Measure Information:
Title
Acceptability of the newborn massage intervention
Description
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%.
Time Frame
Through study completion, up to one year
Title
Feasibility of recruitment
Description
Feasibility of recruitment will be defined by at least 30% of approached, eligible participants consenting to participate.
Time Frame
Ascertained following completion of recruitment of 30 study participants. Through study completion, up to an average of one year.
Secondary Outcome Measure Information:
Title
Difference between transcutaneous bilirubin level and AAP phototherapy threshold on the day of discharge
Description
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)
Time Frame
Value at obtained at hospital discharge will be evaluated at the end of study completion, up to one year
Title
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
Title
Timing of first transitional (non-meconium) stool passage
Time Frame
Ascertained at 1-2 week survey
Title
Parental satisfaction with newborn massage
Description
Parental satisfaction with newborn massage assessed by survey
Time Frame
7-14 day survey
Title
Proportion of participants who read with baby in the last 24 hours
Description
Proportion of participants who read with baby in the last 24 hours assessed by survey
Time Frame
1-2 week survey
Title
Proportion of participants who read with baby in the last week
Description
Proportion of participants who read with baby in the last week assessed by survey
Time Frame
1-2 week survey
Title
Breastfeeding at 1 week of age
Description
Infant received any human milk in the prior 24 hours
Time Frame
1-2 week survey

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Hours
Maximum Age & Unit of Time
48 Hours
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Iesha Miller, MHA
Phone
916-734-3269
Email
itmiller@ucdavis.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Kair, MD, MAS
Organizational Affiliation
UC Davis Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California-Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iesha Miller, MHA
Phone
916-734-4269
Email
itmiller@ucdavis.edu

12. IPD Sharing Statement

Learn more about this trial

Newborn Abdominal Massage to Prevent Hyperbilirubinemia

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