Neonatal HyperbilirubinemiaNCT05077787
Tactile and Kinaesthetic Stimulation in Neonates With Hyperbilirubinaemia
A study testing Massage therapy and Kinaesthetic stimulation in people with Neonatal Hyperbilirubinemia, run by Asir John Samuel at 1 site in India.
Trial summary
Hyperbilirubinemia is the most common problem seen in neonates, owing to severe complications in their lifetime. The study design of the study is pretest - a posttest experimental design. Criterion-based purposive sampling will be used for recruiting the neonates. Read more about this study
- Who is it for?
- Ages 24 hours to 10 daysHealthy volunteers can take part
- Conditions the study is for
- Neonatal Hyperbilirubinemia
- What is being tested?
- Massage therapy and Kinaesthetic stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteIndia
- Study dates
- 1 Apr 2022to 11 Jan 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 24 hours to 10 days
- All sexes
- Healthy volunteers accepted
- Child
- New born in Neonatal Intensive Care Unit
- Stable vitals
- Full Term and Preterm neonates
- Gestational age 34 weeks to 40 weeks
- Birth weight -1800 - 3000 g
- APGAR Score at birth of 8 -10
- Total serum bilirubin levels > 10 mg/dL
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tactile and Kinaesthetic Stimulation in Preterm Neonates With Hyperbilirubinaemia
Hyperbilirubinemia is the most common problem seen in neonates, owing to severe complications in their lifetime. The study design of the study is pretest - a posttest experimental design. Criterion-based purposive sampling will be used for recruiting the neonates. In the study neonates will be selected according to the selection criteria and will be allocated into two groups using computer-based randomization.The Intervention group - neonates will receive tactile and kinesthetic stimulation for 15 minutes for 3 consecutive days, 1 hour after feeding twice daily along with Phototherapy, Control group - Phototherapy alone will be given along with conventional NICU care. Total serum bilirubin will be assessed as outcome measures daily once. Transcutaneous bilirubin will be assessed after every intervention.
- Conditions
- Neonatal Hyperbilirubinemia
- Being tested
- Massage therapy, Kinaesthetic stimulation
- Medical subject headings
- Hyperbilirubinemia, Neonatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Massage therapyOther
Massage therapy includes stroking, kneading, rolling, tapping, vibration and effleurage over the face, chest ,abdomen and back. Massage therapy will be given for 5 minutes and will be repeated twice.
Kinaesthetic stimulationOther
Kinaesthetic stimulation includes passive flexion and extension movements of shoulder joint, elbow joint, hip joint, knee joint and both lower limbs together. It will be given for 5 minutes in each intervention
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Neonates recruited in experimental group will receive massage therapy and kinaesthetic stimulation for 15 minutes along with phototherapy for consecutive days . It will be given in three phases first massage therapy will be given for 5 minutes, followed by movement of limbs for 5 minutes and then again massage therapy will be repeated for 5 minutes. Receives: Other: Massage therapy; Other: Kinaesthetic stimulation |
| Control Group | No intervention | Neonates recruited in control group will receive phototherapy alone along with regular care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Serum Bilirubin (TSB)
It will measure total bilirubin level in blood of neonates
Measured: Changes in the Total Serum Bilirubin level will be measured at baseline and at the end of three days intervention
Transcutaneous Bilirubin (TcB)
Transcutaneous Bilirubin will measure neonatal jaundice.
Measured: Changes in the Transcutaneous Bilirubin level will be measured daily for three days before and after intervention
Weight Gain
Weight gain will evaluate the change in neonatal weight
Measured: Changes in the weight will be measured at baseline and at the end of three days intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start1 Apr 2022
- Primary completion11 Jan 2024
- Study completion11 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Neonatal HyperbilirubinemiaStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asir John Samuel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Asir John Samuel, Maharishi Markendeswar University (Deemed to be University)
- Investigators
- Saumya Kothiyal, MPT, Principal investigator, Maharishi Markendeshawar (Deemed to be University)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05077787
- Sponsor's protocol ID
- U1111-1269-9921
- Status last verified
- Jan 2024
- First submitted
- 1 Oct 2021
- Last updated
- 29 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rahmawati D, Sampurna MTA, Etika R, Utomo MT, Bos AF. Transcutaneous bilirubin level to predict hyperbilirubinemia in preterm neonates. F1000Res. 2020 Apr 28;9:300. doi: 10.12688/f1000research.22264.2. eCollection 2020.
PubMed 33014346Lin CH, Yang HC, Cheng CS, Yen CE. Effects of infant massage on jaundiced neonates undergoing phototherapy. Ital J Pediatr. 2015 Nov 25;41:94. doi: 10.1186/s13052-015-0202-y.
PubMed 26607061Field T. Pediatric Massage Therapy Research: A Narrative Review. Children (Basel). 2019 Jun 6;6(6):78. doi: 10.3390/children6060078.
PubMed 31174382Niemi AK. Review of Randomized Controlled Trials of Massage in Preterm Infants. Children (Basel). 2017 Apr 3;4(4):21. doi: 10.3390/children4040021.
PubMed 28368368
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tactile and Kinaesthetic Stimulation in Preterm Neonates With Hyperbilirubinaemia
- ClinicalTrials.gov ID
- NCT05077787
- Acronym / sponsor ID
- U1111-1269-9921
- Conditions
- Neonatal Hyperbilirubinemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Asir John SamuelUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 11 Jan 2024 (actual)
- Study completion
- 11 Jan 2024 (actual)
- First posted
- 14 Oct 2021 (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.
Hyperbilirubinemia is the most common problem seen in neonates, owing to severe complications in their lifetime. The study design of the study is pretest - a posttest experimental design. Criterion-based purposive sampling will be used for recruiting the neonates. In the study neonates will be selected according to the selection criteria and will be allocated into two groups using computer-based randomization.The Intervention group - neonates will receive tactile and kinesthetic stimulation for 15 minutes for 3 consecutive days, 1 hour after feeding twice daily along with Phototherapy, Control group - Phototherapy alone will be given along with conventional NICU care. Total serum bilirubin will be assessed as outcome measures daily once. Transcutaneous bilirubin will be assessed after every intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Massage therapy, Other: Kinaesthetic stimulationNeonates recruited in experimental group will receive massage therapy and kinaesthetic stimulation for 15 minutes along with phototherapy for consecutive days . It will be given in three phases first massage therapy will be given for 5 minutes, followed by movement of limbs for 5 minutes and then again massage therapy will be repeated for 5 minutes. |
| Control Group | No intervention | –Neonates recruited in control group will receive phototherapy alone along with regular care |
Who may qualify
- Ages
- 24 hours to 10 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
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 |
|---|---|---|
| Massage therapyMassage therapy includes stroking, kneading, rolling, tapping, vibration and effleurage over the face, chest ,abdomen and back. Massage therapy will be given for 5 minutes and will be repeated twice. | Other | Experimental Group |
| Kinaesthetic stimulationKinaesthetic stimulation includes passive flexion and extension movements of shoulder joint, elbow joint, hip joint, knee joint and both lower limbs together. It will be given for 5 minutes in each intervention | Other | Experimental Group |
Primary outcome
Total Serum Bilirubin (TSB)
Time frame: Changes in the Total Serum Bilirubin level will be measured at baseline and at the end of three days intervention
It will measure total bilirubin level in blood of neonates
Transcutaneous Bilirubin (TcB)
Time frame: Changes in the Transcutaneous Bilirubin level will be measured daily for three days before and after intervention
Transcutaneous Bilirubin will measure neonatal jaundice.
Weight Gain
Time frame: Changes in the weight will be measured at baseline and at the end of three days intervention
Weight gain will evaluate the change in neonatal weight
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 29 Jan 2024.
- Background: PubMed 33014346Rahmawati D, Sampurna MTA, Etika R, Utomo MT, Bos AF. Transcutaneous bilirubin level to predict hyperbilirubinemia in preterm neonates. F1000Res. 2020 Apr 28;9:300. doi: 10.12688/f1000research.22264.2. eCollection 2020.
- Background: PubMed 26607061Lin CH, Yang HC, Cheng CS, Yen CE. Effects of infant massage on jaundiced neonates undergoing phototherapy. Ital J Pediatr. 2015 Nov 25;41:94. doi: 10.1186/s13052-015-0202-y.
- Background: PubMed 31174382Field T. Pediatric Massage Therapy Research: A Narrative Review. Children (Basel). 2019 Jun 6;6(6):78. doi: 10.3390/children6060078.
- Background: PubMed 28368368Niemi AK. Review of Randomized Controlled Trials of Massage in Preterm Infants. Children (Basel). 2017 Apr 3;4(4):21. doi: 10.3390/children4040021.
- 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.
Saumya Kothiyal, MPT principal investigator
Maharishi Markendeshawar (Deemed to be 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 Massage therapy and Kinaesthetic stimulation in people with Neonatal Hyperbilirubinemia, run by Asir John Samuel at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 29 Jan 2024. 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 India. 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?
Total Serum Bilirubin (TSB) (time frame: Changes in the Total Serum Bilirubin level will be measured at baseline and at the end of three days intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05077787, which also lists 4 linked publications.
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 29 Jan 2024.