PretermNCT07106164
The Effect of Total Body Massage on Neonatal Jaundice in Preterm Neonates
A study testing total body massage and photo therapy in people with Preterm and Neonatal Hyperbilirubinemia, run by Ain Shams University at 1 site in Egypt.
Trial summary
Different methods are subscribed for the lowering of the bilirubin level, the most important of which are: exchange transfusion, phototherapy and using pharmacological agents. However, the remedial practice that has become most common for curing hyperbilirubinemia is phototherapy, has several side-effects. Read more about this study
- Who is it for?
- Ages 1 hour to 30 days
- Conditions the study is for
- Preterm, Neonatal Hyperbilirubinemia
- What is being tested?
- total body massage and photo therapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2023to 1 Jun 2024
- 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 1 hour to 30 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm neonates from 32 to 36 wks gestational age.
- Hyperbilirubinemia needing phototherapy.
Who cannot join
- Serious congenital malformation.
- Fetal hydrops.
- Hemolytic jaundice.
- Confirmed intrauterine infection (toxoplasmosis, rubella, cytomegalovirus, syphilis and herpes).
- Bilirubin level near exchange transfusion level.
- Any skeletal abnormality or joint affection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Total Body Massage on Neonatal Jaundice in Preterm Neonates: A Randomized Controlled Trial
Different methods are subscribed for the lowering of the bilirubin level, the most important of which are: exchange transfusion, phototherapy and using pharmacological agents. However, the remedial practice that has become most common for curing hyperbilirubinemia is phototherapy, has several side-effects. Thus there is constant research going on to find a substitute for phototherapy or to lessen its duration such as total body massage.
Read the detailed description
Neonatal jaundice or hyperbilirubinemia is mostly cured (20% cases) though it can still prove hazardous and need medical intervention The most life-threatening case arising from this condition is kernicterus. Unfortunately, this condition is fatal in 75% cases and 80% of those who stay alive do not escape unscathed and exhibit problems related to the nervous system. Thus a timely cure of neonatal hyperbilirubinemia has become a major preventive measure Different methods are subscribed for the lowering of the bilirubin level, the most important of which are: exchange transfusion, phototherapy and using pharmacological agents . However, the most used treatment for curing hyperbilirubinemia is phototherapy, which has several side-effects ranging from doing harm to the cornea and the genital region to causing dehydration, diarrhoea and bronze kid syndrome. Thus there is constant research going on to find a substitute for phototherapy or to lessen the duration of the same.
Infant massage is a traditional practice in several regions of the world, to be more precise, in the cultures of Africa and Asia. A survey done recently in Bangladesh showed that 96% of the caretakers of neonates engaged in massaging the whole body of the infant one to three times a day. Healthcare practitioners in the West have also started to show interest in infant massage, especially, as an interventional measure for infants in neonatal intensive care units (NICUs) where mostly the environment is stressful and lacks adequate tactile stimulation. In order to promote infant growth, more parents and caretakers of low-risk babies are being trained in massage in the Western world studies have showed that massage stimulation encourages the passing of more meconium containing bilirubin by newborns and suggested that neonate massage can contribute toward the prevention of neonatal jaundice and the controlling of bilirubin to within normal range Taking all the above into account, this research was carried out with the aim of studying the effect of massage, using Field's Technique, on neonatal jaundice in preterm newborns on phototherapy.
- Conditions
- Preterm, Neonatal Hyperbilirubinemia
- Being tested
- total body massage, photo therapy
- Medical subject headings
- Premature Birth, Hyperbilirubinemia, Neonatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total body massageProcedure or surgery
Massage was done using the Field's Technique after starting phototherapy till discontinuation of phototherapy for 15 - 20 minutes, three times daily 1 hour after the morning, mid- day feeds and at night.
photo therapyDevice
neonates received phototherapy for the neonatal hyperbilirubinemia
| Study group | Role | What they receive |
|---|---|---|
| total body massage | Experimental | patients received total body massage and phototherapy Receives: Procedure: total body massage; Device: photo therapy |
| control | Active comparator | neonates received phototherapy only Receives: Device: photo therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
stool motions per day
Number of times the newborn passes stool will be recorded daily throughout phototherapy and total body massage
Measured: baseline and daily throughout study completion, an average of 3 months
bilirubin level
Serum bilirubin recorded on the start of treatment before any massage intervention and regular follow up till discontinuation of phototherapy and rebound level upon stoppage of phototherapy.
Measured: baseline and throughout study completion, an average of 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start1 Jun 2023
- Primary completion1 Dec 2023
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PretermStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Ibrahim, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07106164
- Sponsor's protocol ID
- total body massage & jaundice
- Status last verified
- Aug 2025
- First submitted
- 17 Jul 2025
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: data can be shared upon reasonable request from the corresponding author
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Total Body Massage on Neonatal Jaundice in Preterm Neonates: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07106164
- Acronym / sponsor ID
- total body massage & jaundice
- Conditions
- Preterm, Neonatal Hyperbilirubinemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 6 Aug 2025 (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.
Different methods are subscribed for the lowering of the bilirubin level, the most important of which are: exchange transfusion, phototherapy and using pharmacological agents. However, the remedial practice that has become most common for curing hyperbilirubinemia is phototherapy, has several side-effects. Thus there is constant research going on to find a substitute for phototherapy or to lessen its duration such as total body massage.
Detailed description
Neonatal jaundice or hyperbilirubinemia is mostly cured (20% cases) though it can still prove hazardous and need medical intervention The most life-threatening case arising from this condition is kernicterus. Unfortunately, this condition is fatal in 75% cases and 80% of those who stay alive do not escape unscathed and exhibit problems related to the nervous system. Thus a timely cure of neonatal hyperbilirubinemia has become a major preventive measure Different methods are subscribed for the lowering of the bilirubin level, the most important of which are: exchange transfusion, phototherapy and using pharmacological agents . However, the most used treatment for curing hyperbilirubinemia is phototherapy, which has several side-effects ranging from doing harm to the cornea and the genital region to causing dehydration, diarrhoea and bronze kid syndrome. Thus there is constant research going on to find a substitute for phototherapy or to lessen the duration of the same.
Infant massage is a traditional practice in several regions of the world, to be more precise, in the cultures of Africa and Asia. A survey done recently in Bangladesh showed that 96% of the caretakers of neonates engaged in massaging the whole body of the infant one to three times a day. Healthcare practitioners in the West have also started to show interest in infant massage, especially, as an interventional measure for infants in neonatal intensive care units (NICUs) where mostly the environment is stressful and lacks adequate tactile stimulation. In order to promote infant growth, more parents and caretakers of low-risk babies are being trained in massage in the Western world studies have showed that massage stimulation encourages the passing of more meconium containing bilirubin by newborns and suggested that neonate massage can contribute toward the prevention of neonatal jaundice and the controlling of bilirubin to within normal range Taking all the above into account, this research was carried out with the aim of studying the effect of massage, using Field's Technique, on neonatal jaundice in preterm newborns on phototherapy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| total body massage | Experimental | Procedure: total body massage, Device: photo therapypatients received total body massage and phototherapy |
| control | Active comparator | Device: photo therapyneonates received phototherapy only |
Who may qualify
- Ages
- 1 hour to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Preterm neonates from 32 to 36 wks gestational age.
- Hyperbilirubinemia needing phototherapy.
Key exclusion criteria (6 listed)
- Serious congenital malformation.
- Fetal hydrops.
- Hemolytic jaundice.
- Confirmed intrauterine infection (toxoplasmosis, rubella, cytomegalovirus, syphilis and herpes).
- Bilirubin level near exchange transfusion level.
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 |
|---|---|---|
| total body massageMassage was done using the Field's Technique after starting phototherapy till discontinuation of phototherapy for 15 - 20 minutes, three times daily 1 hour after the morning, mid- day feeds and at night. | Procedure or surgery | total body massage |
| photo therapyneonates received phototherapy for the neonatal hyperbilirubinemia | Device | control, total body massage |
Primary outcome
stool motions per day
Time frame: baseline and daily throughout study completion, an average of 3 months
Number of times the newborn passes stool will be recorded daily throughout phototherapy and total body massage
bilirubin level
Time frame: baseline and throughout study completion, an average of 3 month
Serum bilirubin recorded on the start of treatment before any massage intervention and regular follow up till discontinuation of phototherapy and rebound level upon stoppage of phototherapy.
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 6 Aug 2025.
- Individual participant dataSharing planned: Yes. data can be shared upon reasonable request from the corresponding author
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing total body massage and photo therapy in people with Preterm and Neonatal Hyperbilirubinemia, run by Ain Shams University at 1 site in Egypt.
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 2 inclusion and 6 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 6 Aug 2025. 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 Egypt. 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?
stool motions per day (time frame: baseline and daily throughout study completion, an average of 3 months). The study lists 2 primary outcomes in all. 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 6 Aug 2025.