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Abdominal Massage for Newborn Jaundice

N/A
Recruiting
Led By Laura Kair, MD, MAS
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Less than 48 hours of age at enrollment
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up value at obtained at hospital discharge will be evaluated at the end of study completion, up to one year
Awards & highlights

Study Summary

This trialwill research a new way to prevent jaundice in newborns in US healthcare settings.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since the interventions involve non-invasive techniques like abdominal massage and reading, significant side effects are not anticipated. However, any unexpected reactions will be monitored closely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am enrolling my newborn who is less than 2 days old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, up to one year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to one year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acceptability of the newborn massage intervention
Feasibility of recruitment
Secondary outcome measures
Breastfeeding at 1 week of age
Difference between transcutaneous bilirubin level and AAP phototherapy threshold on the day of discharge
Number of stools in prior 24 hours (at hospital discharge)
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Massage InterventionExperimental Treatment1 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 InterventionExperimental Treatment1 Intervention
Families will be provided with information about reading with baby.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abdominal massage
2019
N/A
~550

Find a Location

Who is running the clinical trial?

University of California, DavisLead Sponsor
909 Previous Clinical Trials
4,704,100 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,684 Previous Clinical Trials
6,930,868 Total Patients Enrolled
1 Trials studying Newborn Jaundice
203 Patients Enrolled for Newborn Jaundice
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,953 Previous Clinical Trials
2,660,450 Total Patients Enrolled
1 Trials studying Newborn Jaundice
203 Patients Enrolled for Newborn Jaundice

Media Library

Abdominal massage Clinical Trial Eligibility Overview. Trial Name: NCT05282394 — N/A
Newborn Jaundice Research Study Groups: Massage Intervention, Attention Control Intervention
Newborn Jaundice Clinical Trial 2023: Abdominal massage Highlights & Side Effects. Trial Name: NCT05282394 — N/A
Abdominal massage 2023 Treatment Timeline for Medical Study. Trial Name: NCT05282394 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment presently enrolling participants?

"According to clinicaltrials.gov, this medical trial is actively seeking participants for enrollment. The project was originally advertised on August 1st 2022 and the last update was done on October 22nd 2022."

Answered by AI

Is the age restriction for this clinical experiment above or below twenty years old?

"To be considered, applicants must fall between the ages of 0 hours and 48 hours. This study is mainly focused on younger patients, with 13 trials designated for those under 18 years old, while 3 are aimed at individuals over 65."

Answered by AI

How many participants is this research endeavor seeking?

"Indeed, clinicaltrials.gov conveys that this experiment is presently recruiting subjects. It was initially published on August 1st 2022 and latest updates were made October 22nd of the same year; it aims to enrol 30 people from one site."

Answered by AI
~12 spots leftby Mar 2025