MassageNCT04099602
The Effect of Massage on Bilirubin Level in Infants
A study testing Baby Massage in people with Massage and Neonatal Jaundice, run by Ege University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 32 weeks to 38 monthsHealthy volunteers can take part
- Conditions the study is for
- Massage, Neonatal Jaundice
- What is being tested?
- Baby Massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Apr 2018to 18 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 32 weeks to 38 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Show all 9Show fewer
- the absence of congenital major malformation of the infants
- the lack of patent ductus arteriosus requiring treatment
- no proven sepsis diagnosis
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University Faculty of Nursing
Izmir, Bornova, 35100
About this study
Official title: Investigation of the Effect of Massage on Bilirubin Level in Preterm Infants
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.
Read the 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.
- Conditions
- Massage, Neonatal Jaundice
- Being tested
- Baby Massage
- Keywords
- neonatal jaundice, baby massage, transcutaneous bilirubin level, premature infant
- Medical subject headings
- Jaundice, Neonatal, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baby MassageOther
Received baby massage and bilirubin levels were measured twice daily by the transcutaneous bilirubin meter for 5 days
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transcutaneous Bilirubin Levels
bilirubin level mg/dl
Measured: "through study completion, an average of 1 year"
Secondary outcomes (1)
frequency of defecation
daily number
Measured: "through study completion, an average of 1 year"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study start6 Apr 2018
- Primary completion6 Apr 2019
- Study completion18 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MassageStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gönül Kılıç, Ege University
- Investigators
- Hatice Bal Yılmaz, Prof., Study director, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04099602
- Sponsor's protocol ID
- EgeU
- Status last verified
- Sep 2019
- First submitted
- 18 Sep 2019
- Last updated
- 27 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Massage on Bilirubin Level in Preterm Infants
- ClinicalTrials.gov ID
- NCT04099602
- Acronym / sponsor ID
- EgeU
- Conditions
- Massage, Neonatal Jaundice
- Keywords
- neonatal jaundice, baby massage, transcutaneous bilirubin level, premature infant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 6 Apr 2018 (actual)
- Primary completion
- 6 Apr 2019 (actual)
- Study completion
- 18 Jul 2019 (actual)
- First posted
- 23 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Massage group | Experimental | Other: Baby MassageTwice 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. |
| 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 |
Who may qualify
- Ages
- 32 weeks to 38 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baby MassageReceived baby massage and bilirubin levels were measured twice daily by the transcutaneous bilirubin meter for 5 days | Other | Massage group |
Primary outcome
Transcutaneous Bilirubin Levels
Time frame: "through study completion, an average of 1 year"
bilirubin level mg/dl
1 secondary outcome
frequency of defecation
Time frame: "through study completion, an average of 1 year"
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hatice Bal Yılmaz, Prof. study director
Ege University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baby Massage in people with Massage and Neonatal Jaundice, run by Ege University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transcutaneous Bilirubin Levels (time frame: "through study completion, an average of 1 year"). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2019.