Hyperbilirubinemia, Neonatal Clinical Trial
Official title:
The Effect of Massage on the Bilirubin Level in Term Infants Receiving Phototherapy
NCT number | NCT05356273 |
Other study ID # | 2021/84 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 1, 2021 |
Est. completion date | January 1, 2022 |
Verified date | September 2022 |
Source | Istanbul University-Cerrahpasa |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Background: It has been reported in the current literature that massage has various positive physiological effects on the newborn. Also baby massage; It increases the collection and excretion of waste products such as bilirubin by accelerating the flow of blood, lymph and tissue fluids. Our aim is to investigate the effect of infant massage on hyperbilirubinemia in newborns receiving phototherapy. Method: The population of the study consisted of babies who were hospitalized in Istanbul Haseki Training and Research Hospital Neonatal Intensive Care Unit between October 2021 and January 2022 and needed phototherapy. Transcutaneous bilirubin device and data collection form were used to obtain the data. 61 newborns who met the study criteria were randomly divided into experimental (n=30) and control (n=31) groups. Phototherapy was applied to all babies twice a day. In addition to phototherapy, infant massage was applied to the experimental group for 10 minutes just before the phototherapy. Bilirubin level measurements were made 2 hours after the end of phototherapy for both groups. Diaper changes for both groups were carried out 8 times a day, every 3 hours.
Status | Completed |
Enrollment | 61 |
Est. completion date | January 1, 2022 |
Est. primary completion date | January 1, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 1 Day to 28 Days |
Eligibility | Inclusion Criteria: - Born between 37-42 gestational weeks - Birth weight between 2500-4000gr - 1st and 5th Apgar score between 7-10 - Needing phototherapy treatment - Diagnosed with indirect hyperbilirubinemia 24 hours or more after birth - Orally fed - No health problems other than indirect hyperbilirubinemia - Newborns who has stable vital signs Exclusion Criteria: - ABO blood incompatibility or Rh incompatibility - Diagnosed with direct hyperbilirubinemia - Newborns who has skin anomaly - Needing fluid replacement - Newborns with gastrointestinal disorders |
Country | Name | City | State |
---|---|---|---|
Turkey | Istanbul University Cerrahpasa | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Istanbul University-Cerrahpasa |
Turkey,
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* Note: There are 17 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bilirubin levels | decreasing bilirubin levels within intervention times | 72 hours | |
Secondary | Stool frequency | increasing stool frequency within intervention times | 72 hours |
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