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Active, Not Recruiting

NCT Number: NCT05282394

Newborn Abdominal Massage to Prevent Hyperbilirubinemia

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Newborn Jaundice Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hyperbilirubinemia Hyperbilirubinemia, Neonatal Infant, Newborn, Diseases Jaundice, Neonatal Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

0 hour–48 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California-Davis

Sacramento, California, 95817, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Abdominal Massage

Procedure

abdominal massage

Reading

Other

guidance given to parents about reading with baby

Primary outcomes

  1. 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%.

  2. 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.

Secondary outcomes

  1. 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

    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)

  2. 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

  3. Timing of first transitional (non-meconium) stool passage

    Time frame: Ascertained at 1-2 week survey

  4. Parental satisfaction with newborn massage

    Time frame: 7-14 day survey

    Parental satisfaction with newborn massage assessed by survey

  5. 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 24 hours assessed by survey

  6. Proportion of participants who read with baby in the last week

    Time frame: 1-2 week survey

    Proportion of participants who read with baby in the last week assessed by survey

  7. Breastfeeding at 1 week of age

    Time frame: 1-2 week survey

    Infant received any human milk in the prior 24 hours

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

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

Registry information

Official study title

Newborn Abdominal Massage to Prevent Hyperbilirubinemia: A Pilot Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Mar 16, 2022
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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