search
Back to results

The Effect of Massage on Bilirubin Level in Infants

Primary Purpose

Massage, Neonatal Jaundice

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Baby Massage
Sponsored by
Ege University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Massage focused on measuring neonatal jaundice, baby massage, transcutaneous bilirubin level, premature infant

Eligibility Criteria

32 Weeks - 38 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ege University Faculty of Nursing

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Massage group

Control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Transcutaneous Bilirubin Levels
bilirubin level mg/dl

Secondary Outcome Measures

frequency of defecation
daily number

Full Information

First Posted
September 18, 2019
Last Updated
September 25, 2019
Sponsor
Ege University
search

1. Study Identification

Unique Protocol Identification Number
NCT04099602
Brief Title
The Effect of Massage on Bilirubin Level in Infants
Official Title
Investigation of the Effect of Massage on Bilirubin Level in Preterm Infants
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
April 6, 2018 (Actual)
Primary Completion Date
April 6, 2019 (Actual)
Study Completion Date
July 18, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ege University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Neonatal jaundice is a physiological condition seen in 60% of infants and 80% of preterm infants in the first week of life. There is no clear data on the frequency of jaundice in newborns in our country. Jaundice is one of the common causes of 75% of hospitalizations in the first week after birth and the recurrence of hospitalizations in the neonatal period. Neonatal jaundice is a non-hazardous and transient condition that can usually resolve spontaneously without treatment. Although it is a transient condition, high bilirubin levels can cause kernicterus which causes severe neurological damage if not diagnosed and treated early . The severity and complications of hyperbilirubinemia in premature infants are different from term infants. Premature infants are more susceptible to damage caused by serum bilirubin, even at low levels of brain cells. Hyperbilirubinemia in preterm infants is more prevalent, severe, and protracted than that in term infants because of the immaturity of their red blood cells, livers, and gastrointestinal tracts. There also is often a delay in enteral feeds, which may limit intestinal flow and bacterial colonization, resulting in further enhancement of the enterohepatic circulation of bilirubin. Preterm neonates are more susceptible to bilirubin neurotoxicity. Almost all preterm infants less than 35 weeks gestational age have elevated total serum/plasma bilirubin levels, which results in neonatal jaundice, the yellowish discoloration of the skin and conjunctiva caused by bilirubin deposition. The major complication of an elevated total serum (hyperbilirubinemia) is bilirubin-induced neurologic dysfunction (BIND), which occurs when circulating bilirubin crosses the blood-brain barrier and binds to brain tissue . Jaundice is an important problem in newborn infants and death and severe sequelae due to hyperbilirubinemia can be prevented by early diagnosis and treatment. Various treatment methods have been developed to reduce bilirubin levels. The most commonly used methods are; blood exchange, phototherapy and pharmacological agents. Therapeutic interventions prevent BIND and thus kernicterus by lowering the level of bilirubin in the blood. Phototherapy is a common treatment for both treatment and prevention of increased bilirubin levels. Phototherapy has been widely used in the treatment of hyperbilirubinemia of the newborn for more than fifty years. Phototherapy has various side effects, such as damage to the retina and genitalia, loss of body water, skin rashes, watery stools and Bronze Baby Syndrome. Nowadays, studies on new treatment methods and different applications are being made which support the treatment of jaundice and shorten the length of hospital stay. Kangaroo care reduces the exposure of newborns to phototherapy, swimming, wiping and bathtub bathing have been reported to reduce bilirubin levels. Baby massage is one of the alternative and complementary therapies that can be used to reduce bilirubin levels. While there are many studies investigating the effect of infant massage on bilirubin levels in term neonates with healthy and hyperbilirubinemia, a limited number of studies investigating the effect of massage on bilirubin levels in premature infants were found. It is suggested that baby massage can be performed by trained nurses and mothers trained by nurses. Infant massage stimulates defecation by increasing bowel movements, thus decreasing enterohepatic circulation and increasing bilirubin excretion. Bilirubin excretion decreases the speed and severity of hyperbilirubinemia. In some studies investigating the effect of massage on bilirubin levels, transcutaneous bilirubin (TcB) levels or TSB levels were found to be significantly lower, also no significant difference was found in some studies. In our country, the studies on the benefits of baby massage for infants are quite new. There are two studies investigating the effect of massage on bilirubin levels in newborn infants. However, in one of these studies, the effect of infant massage on bilirubin levels in newborns who received phototherapy was investigated, while the effect of abdominal massage on TcB bilirubin levels in newborns was investigated in the other study. TSB levels are the gold standard in the evaluation of bilirubin levels in newborn infants. However, the blood needs to be taken from the baby, and taking blood is a painful procedure, and it may not always possible to get enough blood. Measurement of bilirubin level from the skin surface is both noninvasive, painless and simple. In this study, the effect of infant massage on bilirubin level in premature infants not receiving phototherapy was evaluated by transcutaneous bilirubin measurement method. This study was designed as a randomized controlled trial to investigate the effect of massage on bilirubin levels in premature infants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Massage, Neonatal Jaundice
Keywords
neonatal jaundice, baby massage, transcutaneous bilirubin level, premature infant

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Massage group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group who were administered standard care and bilirubin levels were measured twice daily by the transcutaneous bilirubin meter for 5 days
Intervention Type
Other
Intervention Name(s)
Baby Massage
Intervention Description
Received baby massage and bilirubin levels were measured twice daily by the transcutaneous bilirubin meter for 5 days
Primary Outcome Measure Information:
Title
Transcutaneous Bilirubin Levels
Description
bilirubin level mg/dl
Time Frame
"through study completion, an average of 1 year"
Secondary Outcome Measure Information:
Title
frequency of defecation
Description
daily number
Time Frame
"through study completion, an average of 1 year"
Other Pre-specified Outcome Measures:
Title
length of hospital stay
Description
number of days in hospital
Time Frame
"through study completion, an average of 1 year"

10. Eligibility

Sex
All
Minimum Age & Unit of Time
32 Weeks
Maximum Age & Unit of Time
38 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hatice Bal Yılmaz, Prof.
Organizational Affiliation
Ege University
Official's Role
Study Director
Facility Information:
Facility Name
Ege University Faculty of Nursing
City
Izmir
State/Province
Bornova
ZIP/Postal Code
35100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effect of Massage on Bilirubin Level in Infants

We'll reach out to this number within 24 hrs