Neonatal JaundiceNCT06595368
Comparing the Effect of Vimala Massage Versus Hydrotherapy on the Clinical Outcomes of Neonatal Hyperbilirubinemia
A study testing Vimala massage and Hydrotherapy in people with Neonatal Jaundice, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the effect of Vimala massage versus hydrotherapy on the clinical outcomes of neonatal hyperbilirubinemia. Read more about this study
- Who is it for?
- Ages 37 to 42 weeksHealthy volunteers can take part
- Conditions the study is for
- Neonatal Jaundice
- What is being tested?
- Vimala massage and Hydrotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2024to 30 Jan 2025
- 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 37 to 42 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- full-term neonates aged 37- 42 weeks of gestation with a birth weight of ≥1500 g and a five-minute Apgar score of seven or above. Furthermore, the newborn with physiological jaundice will be admitted for phototherapy from the first to the tenth day, and the infant's vital signs will remain normal
Who cannot join
- major congenital malformations, intestinal obstruction, congenital heart disease, sepsis, neonates with a disease that disrupts skin integrity (epidermolysis bullosa, ichthyosis, collodion baby).
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Kafrelsheikh University
Kafr ash Shaykh, Kafr el-Sheikh Governorate, 33516
About this study
Official title: A Randomized Controlled Trial Comparing the Efficacy of Vimala Massage Versus Hydrotherapy on Clinical Outcomes in Neonatal Hyperbilirubinemia
The aim of this study is to evaluate the effect of Vimala massage versus hydrotherapy on the clinical outcomes of neonatal hyperbilirubinemia.
Read the detailed description
The researchers explained the study's aim, benefits, and procedures for participation, after that the parents of the neonates provided an informed consent. Neonatal baseline data was collected from their records on the first day of admission for the three groups prior to intervention in order to identify neonates who meet the required criteria of the study. then the participants were selected and divided randomly (using a simple random method) into three equal groups. One subject for the control group, one for the study group (I), then the other for study group (II), and so on, distributed the participants into three equivalent groups as fellow:
Control Group: Consisted of 30 newborns who will receive conventional hospital care with no additional interventions.
Study Group (I): Consisted of 30 neonates who will receive Vimala massage. The massage will be given three times per day, each lasting 15 minutes and planned one hour after the first feeding of each shift.
Study Group (II): Consisted of 30 neonates who will receive hydrotherapy. It will be applied two times per day before feeding, each lasting 5-10 min.
- Conditions
- Neonatal Jaundice
- Being tested
- Vimala massage, Hydrotherapy
- Medical subject headings
- Jaundice, Neonatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vimala massageProcedure or surgery
The massage will be given three times per day, each lasting 15 minutes and planned one hour after the first feeding of each shift.
HydrotherapyProcedure or surgery
Hydrotherapy will be applied two times per day before feeding, each lasting 5-10 min.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Consisted of 30 newborns who will receive conventional hospital care with no additional interventions. |
| Study group I (Vimala group) | Experimental | Consisted of 30 neonates who will receive Vimala massage. Receives: Procedure: Vimala massage |
| Study group II (Hydrotherapy) | Active comparator | Consisted of 30 neonates who will receive hydrotherapy. Receives: Procedure: Hydrotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of Total serum bilirubin level on Total serum bilirubin level monitoring sheet
Total serum bilirubin level monitoring sheet: it includes 2 tests of total serum bilirubin level \& indirect serum bilirubin tests. The daily measurement will be done, its primary purpose is to evaluate the effect of Vimala massage and hydrotherapy on newborns with Jaundice undergoing phototherapy. Bilirubin will be measured using microassay.
Measured: Daily measurement from first day of neonate's admission to day 5 of admission
Change from baseline of neonate's weight on Bilirubin excretion monitoring sheet
Bilirubin excretion monitoring sheet: it includes daily measurement of the neonate's weight
Measured: Daily measurement from first day of neonate's admission to day 5 of admission
Change from baseline of neonate's number of diaper exchange to monitor the frequency of defection and amount of stool on Bilirubin excretion monitoring sheet
Bilirubin excretion monitoring sheet: it includes daily monitoring of infant's diaper exchange to monitor the frequency of defection and amount of stool
Measured: Daily measurement from first day of neonate's admission to day 5 of admission
Change from baseline of neonate's total feeding amount on Bilirubin excretion monitoring sheet
Bilirubin excretion monitoring sheet: it includes daily monitoring of neonate's total feeding amount
Measured: Daily measurement from first day of neonate's admission to day 5 of admission
Secondary outcomes (1)
Estimate the time of jaundice regression and duration of phototherapy on Clinical efficacy monitoring tool
Clinical efficacy monitoring tool was developed by researchers after a review of relevant literature to assess the effectiveness of Vimala massage and Hydrotherapy in accelerating the regression time of jaundice.
Measured: through 5 days from admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Jul 2024
- Primary completion1 Nov 2024
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal JaundiceStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh 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
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Wardany Abdelaal Mohamed, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06595368
- Sponsor's protocol ID
- KafrelsheikhU3
- Status last verified
- Jun 2025
- First submitted
- 10 Sep 2024
- Last updated
- 3 Jul 2025
- Results posted
- 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 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing the Efficacy of Vimala Massage Versus Hydrotherapy on Clinical Outcomes in Neonatal Hyperbilirubinemia
- ClinicalTrials.gov ID
- NCT06595368
- Acronym / sponsor ID
- KafrelsheikhU3
- Conditions
- Neonatal Jaundice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 19 Sep 2024 (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.
The aim of this study is to evaluate the effect of Vimala massage versus hydrotherapy on the clinical outcomes of neonatal hyperbilirubinemia.
Detailed description
The researchers explained the study's aim, benefits, and procedures for participation, after that the parents of the neonates provided an informed consent. Neonatal baseline data was collected from their records on the first day of admission for the three groups prior to intervention in order to identify neonates who meet the required criteria of the study. then the participants were selected and divided randomly (using a simple random method) into three equal groups. One subject for the control group, one for the study group (I), then the other for study group (II), and so on, distributed the participants into three equivalent groups as fellow:
Control Group: Consisted of 30 newborns who will receive conventional hospital care with no additional interventions.
Study Group (I): Consisted of 30 neonates who will receive Vimala massage. The massage will be given three times per day, each lasting 15 minutes and planned one hour after the first feeding of each shift.
Study Group (II): Consisted of 30 neonates who will receive hydrotherapy. It will be applied two times per day before feeding, each lasting 5-10 min.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Consisted of 30 newborns who will receive conventional hospital care with no additional interventions. |
| Study group I (Vimala group) | Experimental | Procedure: Vimala massageConsisted of 30 neonates who will receive Vimala massage. |
| Study group II (Hydrotherapy) | Active comparator | Procedure: HydrotherapyConsisted of 30 neonates who will receive hydrotherapy. |
Who may qualify
- Ages
- 37 to 42 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- full-term neonates aged 37- 42 weeks of gestation with a birth weight of ≥1500 g and a five-minute Apgar score of seven or above. Furthermore, the newborn with physiological jaundice will be admitted for phototherapy from the first to the tenth day, and the infant's vital signs will remain normal
Key exclusion criteria (1 listed)
- major congenital malformations, intestinal obstruction, congenital heart disease, sepsis, neonates with a disease that disrupts skin integrity (epidermolysis bullosa, ichthyosis, collodion baby).
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 |
|---|---|---|
| Vimala massageThe massage will be given three times per day, each lasting 15 minutes and planned one hour after the first feeding of each shift. | Procedure or surgery | Study group I (Vimala group) |
| HydrotherapyHydrotherapy will be applied two times per day before feeding, each lasting 5-10 min. | Procedure or surgery | Study group II (Hydrotherapy) |
Primary outcome
Change from baseline of Total serum bilirubin level on Total serum bilirubin level monitoring sheet
Time frame: Daily measurement from first day of neonate's admission to day 5 of admission
Total serum bilirubin level monitoring sheet: it includes 2 tests of total serum bilirubin level \& indirect serum bilirubin tests. The daily measurement will be done, its primary purpose is to evaluate the effect of Vimala massage and hydrotherapy on newborns with Jaundice undergoing phototherapy. Bilirubin will be measured using microassay.
Change from baseline of neonate's weight on Bilirubin excretion monitoring sheet
Time frame: Daily measurement from first day of neonate's admission to day 5 of admission
Bilirubin excretion monitoring sheet: it includes daily measurement of the neonate's weight
Change from baseline of neonate's number of diaper exchange to monitor the frequency of defection and amount of stool on Bilirubin excretion monitoring sheet
Time frame: Daily measurement from first day of neonate's admission to day 5 of admission
Bilirubin excretion monitoring sheet: it includes daily monitoring of infant's diaper exchange to monitor the frequency of defection and amount of stool
Change from baseline of neonate's total feeding amount on Bilirubin excretion monitoring sheet
Time frame: Daily measurement from first day of neonate's admission to day 5 of admission
Bilirubin excretion monitoring sheet: it includes daily monitoring of neonate's total feeding amount
1 secondary outcome
Estimate the time of jaundice regression and duration of phototherapy on Clinical efficacy monitoring tool
Time frame: through 5 days from admission
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 3 Jul 2025.
- 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.
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 Vimala massage and Hydrotherapy in people with Neonatal Jaundice, run by Kafrelsheikh 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 1 inclusion and 1 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 3 Jul 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?
Change from baseline of Total serum bilirubin level on Total serum bilirubin level monitoring sheet (time frame: Daily measurement from first day of neonate's admission to day 5 of admission). The study lists 4 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 3 Jul 2025.