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The Effect of Massage on Bilirubin Level in Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04099602
Recruitment Status : Completed
First Posted : September 23, 2019
Last Update Posted : September 27, 2019
Sponsor:
Information provided by (Responsible Party):
Gönül Kılıç, Ege University

Brief Summary:
Jaundice (hyperbilirubinemia) which is one of the common causes of repeated hospitalizations in the neonatal period, is a physiological condition seen in 60% of term babies and 80% of premature babies in the first week of life . Premature babies are more susceptible tobilirubin neurotoxicity. Death and severe sequelae due to hyperbilirubinemia can be prevented by early diagnosis and treatment. Massage is one of the applications that can be used to reduce bilirubin levels in newborn infants. Baby massage facilitates bowel movements and bilirubin excretion by reducing enterohepatic circulation. This study was designed as a randomized controlled trial to investigate the effect of massage on bilirubin levels in premature infants.

Condition or disease Intervention/treatment Phase
Massage Neonatal Jaundice Other: Baby Massage Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: In the study, the investigators were decided that at least 30 premature infants were included in each group considering that losses might occur during data collection. Block randomization method was used to control the selection bias that might arise during the determination of the study groups. In this method, the number and probability of groups are equal in each block. Infants in both groups were randomized to block stratified by sex and gestational week. In the block randomization, blocks are selected randomly and this process is continued until all the subjects to be included in the study are assigned to the groups and the number of subjects in the groups is equalized at the end of this procedure
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Investigation of the Effect of Massage on Bilirubin Level in Preterm Infants
Actual Study Start Date : April 6, 2018
Actual Primary Completion Date : April 6, 2019
Actual Study Completion Date : July 18, 2019

Arm Intervention/treatment
Experimental: Massage group
Twice a day after the birth of the baby was massaged by the researcher for 5 days. Bilirubin levels were measured twice daily by the transcutaneous bilirubin meter before the morning massage and 2 hours after the evening massage for 5 days. In the morning (between 07:00-09:00 am) and in the evening (between 19:00-21:00 pm) twice a day, 15-20 minutes baby massage was applied.
Other: Baby Massage
Received baby massage and bilirubin levels were measured twice daily by the transcutaneous bilirubin meter for 5 days

No Intervention: Control group
The control group who were administered standard care and bilirubin levels were measured twice daily by the transcutaneous bilirubin meter for 5 days



Primary Outcome Measures :
  1. Transcutaneous Bilirubin Levels [ Time Frame: "through study completion, an average of 1 year" ]
    bilirubin level mg/dl


Secondary Outcome Measures :
  1. frequency of defecation [ Time Frame: "through study completion, an average of 1 year" ]
    daily number


Other Outcome Measures:
  1. length of hospital stay [ Time Frame: "through study completion, an average of 1 year" ]
    number of days in hospital



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Ages Eligible for Study:   32 Weeks to 38 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • families being voluntary to participate in the study
  • infants being born between 32 and 37 weeks plus 6 days of gestation
  • infants having a birth weight of ≥1500 g
  • infants having a fifth-minute Apgar score of more than seven
  • infant's bilirubin level is not sufficient to require phototherapy
  • the vital signs of the baby are within normal limits
  • the absence of congenital major malformation of the infants
  • the lack of patent ductus arteriosus requiring treatment
  • no proven sepsis diagnosis

Exclusion Criteria:

  • neonates with disease disrupting skin integrity (epidermolysis bullosa, ichthyosis, collodion baby)
  • need for phototherapy
  • infants with gastrointestinal obstruction and biliary atresia
  • infants with congenital major deformations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04099602


Locations
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Turkey
Ege University Faculty of Nursing
Izmir, Bornova, Turkey, 35100
Sponsors and Collaborators
Ege University
Investigators
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Study Director: Hatice Bal Yılmaz, Prof. Ege University
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Responsible Party: Gönül Kılıç, Principal Investigator, Ege University
ClinicalTrials.gov Identifier: NCT04099602    
Other Study ID Numbers: EgeU
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gönül Kılıç, Ege University:
neonatal jaundice
baby massage
transcutaneous bilirubin level
premature infant
Additional relevant MeSH terms:
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Jaundice, Neonatal
Jaundice
Hyperbilirubinemia
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Hyperbilirubinemia, Neonatal
Infant, Newborn, Diseases