The Effect of Massage on Bilirubin Level in Infants

NCT04099602 | Completed

• 1 other identifier: EgeU
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Massage; Neonatal Jaundice

Keywords

neonatal jaundice; baby massage; transcutaneous bilirubin level; premature infant

Outcome Measures

Primary Outcomes (1)

• Transcutaneous Bilirubin Levels

  bilirubin level mg/dl

  "through study completion, an average of 1 year"

Secondary Outcomes (1)

• frequency of defecation

  "through study completion, an average of 1 year"

Other Outcomes (1)

• length of hospital stay

  "through study completion, an average of 1 year"

Study Arms (2)

Massage group

EXPERIMENTAL

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

Control group

NO INTERVENTION

The control group who were administered standard care and bilirubin levels were measured twice daily by the transcutaneous bilirubin meter for 5 days

Interventions

Baby Massage OTHER

Received baby massage and bilirubin levels were measured twice daily by the transcutaneous bilirubin meter for 5 days

Massage group

Eligibility Criteria

• Age: 32 Weeks - 38 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University Faculty of Nursing

Izmir, Bornova, 35100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Jaundice, Neonatal; Premature Birth

Condition Hierarchy (Ancestors)

Hyperbilirubinemia, Neonatal; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Hatice Bal Yılmaz, Prof.

  Ege University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: September 18, 2019
• First Posted: September 23, 2019
• Study Start: April 6, 2018
• Primary Completion: April 6, 2019
• Study Completion: July 18, 2019
• Last Updated: September 27, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)