Newborn JaundiceNCT04962113
Effect of Tub Bathing on Skin and Bilirubin Levels in Infants Undergoing Tunnel and LED of Phototherapy
A study testing TUBE BATH in people with Newborn Jaundice, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The study was conducted as a randomized controlled study to determine effect of tube bathing on skin and bilirubin levels in infants undergoing tunnel and LED of phototherapy. The population of the study consisted of term babies with the diagnosis of hyperbilirubinemia in Gaziantep Cengiz Gökçek Maternity and… Read more about this study
- Who is it for?
- Ages 0 days to 1 month, women only
- Conditions the study is for
- Newborn Jaundice
- What is being tested?
- TUBE BATH
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2019to 1 Sep 2020
- 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 0 days to 1 month
- Women only
- No healthy volunteers
- Child
Who may be able to join
- The baby is receiving phototherapy due to physiological hyperbilirubinemia,
- Being a term newborn,
- Monitoring of the LED group in the incubator and the tunnel group in the tunnel phototherapy device,
- Parents' consent to participate in the study.
Who cannot join
- Rh incompatibility between mother and baby,
- Finding ABO non-compliance,
- Positive direct Coombs test,
- Presence of congenital anomaly or syndrome,
- Any surgical intervention has been or will be made,
- Having any skin lesions,
- The need for mechanical ventilation.
Trial locations and contacts
1 site in 1 country.
About this study
The study was conducted as a randomized controlled study to determine effect of tube bathing on skin and bilirubin levels in infants undergoing tunnel and LED of phototherapy. The population of the study consisted of term babies with the diagnosis of hyperbilirubinemia in Gaziantep Cengiz Gökçek Maternity and Pediatrics Hospital and Kilis State Hospital Neonatal Intensive Care Units (NICU) among November 2019-September 2020. The sample size was composed of a total of 140 babies, which were determined according to Power Analysis and met the case selection criteria. Accordingly, Thirty-five babies were randomly assigned to each group (Tunnel Group = experiment and control; LED Group = experiment and control). The babies in the experimental groups were given a tube bath at 6 and 12 hours after phototherapy started. On the other hand, the babies in the control groups were given routine cares in the units. Data were gathered 'Information and Registration Form', Neonatal Skin Risk Assessment Scale (NSRAS) and Neonatal Skin Condition Score (NSCS).
- Conditions
- Newborn Jaundice
- Being tested
- TUBE BATH
- Keywords
- tube bath, skin care, phototherapy
- Medical subject headings
- Jaundice, Neonatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TUBE BATHOther
Wrap Tube Baht (immersion)
| Study group | Role | What they receive |
|---|---|---|
| Tunnel group Tube bath during the phototherapy | Experimental | Not described Receives: Other: TUBE BATH |
| Tunnel group rutin care | No intervention | Not described |
| LED group Tube bath during the phototherapy | Experimental | Not described Receives: Other: TUBE BATH |
| LED group rutine care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sample size
The sample size was composed of a total of 140 babies, which were determined according to Power Analysis and met the case selection criteria.
Measured: 1-2 month
Divided groups
Thirty-five babies were randomly assigned to each group (Tunnel Group = experiment and control; LED Group = experiment and control).
Measured: 1 month
Experiment difining and time
The babies in the experimental groups were given a tube bath at 6 and 12 hours after phototherapy started. On the other hand, the babies in the control groups were given routine cares in the units.
Measured: 12 month
Measurement
Data were gathered 'Information and Registration Form', Neonatal Skin Risk Assessment Scale (NSRAS) and Neonatal Skin Condition Score (NSCS).
Measured: First, 6-12-24 hours for each nerwborn
Biochemical measurement
Total serum bilirubin values obtained from patient files.
Measured: First, 6-12-24 hours for each nerwborn
TSB Findings
When differences regarding decrease in 24-hour total serum bilirubin (TSB) levels were compared in all relevant experimental groups, statistically differences were observed (p˂ .001). In particular, the levels of bilirubin were listed as LED-trial, Tunnel-trial, Tunnel-control and LED-control, respectively. It is worthy to utter herein that the decline in TSB was more notable in bathing groups.
Measured: 10 month
Skin care findings
Skin integrity and moisture balance were better in bathing groups than control groups, the best was in the Tunnel-experimental group and the worst was in the Tunnel-control group (p˂ .001).
Measured: 10 month
Conclusion
Tube bath is suggested that decreasing total serum bilirubin level and maintaining skin integrity and moisture balance.
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start1 Nov 2019
- Primary completion1 Jun 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Newborn JaundiceStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, SERAP ÖZDEMİR, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04962113
- Sponsor's protocol ID
- IstanbulUC-Pediatri
- Status last verified
- May 2022
- First submitted
- 23 Jun 2021
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bagwell, G. A., & Steward, D. K. (2020). Hematologic System. Comprehensive Neonatal Nursing Care (6th ed.), Springer Publishing Company, 11C. New York, 315-335.
Association of Women's Health, Obstetric and Neonatal Nurses. (2018). Evidence-Based Clinical Practice Guideline: Neonatal Skin Care (4th ed.). Washington, DC.
Brogan J, Rapkin G. Implementing Evidence-Based Neonatal Skin Care With Parent-Performed, Delayed Immersion Baths. Nurs Womens Health. 2017 Dec;21(6):442-450. doi: 10.1016/j.nwh.2017.10.009.
PubMed 29223208Dağ, Y. S., & Yayan, E. H. (2019). The Effect on Bilirubin Levels of Massage, Tub Bath, and Sponge Bath in Newborns with Hyperbilirubinemia: A Randomized ControlLed Trial. European Journal of Integrative Medicine, 27, 70-74.
Kaplan, M., Wong, RJ., Burgis, JC., Sibley E., Stevensen, DK. (2020). Neonatal Jaundice and Liver Diseases, Martin RJ, Fanoroff AA, Walsh MC, Fanaroff and Martin's Neonatal-Perinatal Medicine in 11th Edition, Philadelphia, 91:1788-1852.
Mohammadi Pirkashani, L., Asghari, G., Marofi, M., & Barekatain, B. (2017). Effect of Chicory Extract Bath on Neonatal Bilirubin Levels: A Randomized Clinical Trial Study. International Journal of Pediatrics, 5(12), 6679-6688.
Sherbiny HS, Youssef DM, Sherbini AS, El-Behedy R, Sherief LM. High-intensity light-emitting diode vs fluorescent tubes for intensive phototherapy in neonates. Paediatr Int Child Health. 2016 May;36(2):127-33. doi: 10.1179/2046905515Y.0000000006.
PubMed 25844870Ozdemir S, Balci S. The Effect of Tub Bathing on the Skin and Bilirubin Levels of Babies Receiving Tunnel and Light-Emitting Diode Phototherapies: A Randomized Controlled Trial. Adv Skin Wound Care. 2024 Jul 1;37(7):1-9. doi: 10.1097/ASW.0000000000000163.
PubMed 38899824
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tub Bathing on Skin and Bilirubin Levels in Infants Undergoing Tunnel and LED of Phototherapy
- ClinicalTrials.gov ID
- NCT04962113
- Acronym / sponsor ID
- IstanbulUC-Pediatri
- Conditions
- Newborn Jaundice
- Keywords
- tube bath, skin care, phototherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 14 Jul 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.
The study was conducted as a randomized controlled study to determine effect of tube bathing on skin and bilirubin levels in infants undergoing tunnel and LED of phototherapy. The population of the study consisted of term babies with the diagnosis of hyperbilirubinemia in Gaziantep Cengiz Gökçek Maternity and Pediatrics Hospital and Kilis State Hospital Neonatal Intensive Care Units (NICU) among November 2019-September 2020. The sample size was composed of a total of 140 babies, which were determined according to Power Analysis and met the case selection criteria. Accordingly, Thirty-five babies were randomly assigned to each group (Tunnel Group = experiment and control; LED Group = experiment and control). The babies in the experimental groups were given a tube bath at 6 and 12 hours after phototherapy started. On the other hand, the babies in the control groups were given routine cares in the units. Data were gathered 'Information and Registration Form', Neonatal Skin Risk Assessment Scale (NSRAS) and Neonatal Skin Condition Score (NSCS).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Tunnel group Tube bath during the phototherapy | Experimental | Other: TUBE BATH |
| Tunnel group rutin care | No intervention | – |
| LED group Tube bath during the phototherapy | Experimental | Other: TUBE BATH |
| LED group rutine care | No intervention | – |
Who may qualify
- Ages
- 0 days to 1 month
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- The baby is receiving phototherapy due to physiological hyperbilirubinemia,
- Being a term newborn,
- Monitoring of the LED group in the incubator and the tunnel group in the tunnel phototherapy device,
- Parents' consent to participate in the study.
Key exclusion criteria (7 listed)
- Rh incompatibility between mother and baby,
- Finding ABO non-compliance,
- Positive direct Coombs test,
- Presence of congenital anomaly or syndrome,
- Any surgical intervention has been or will be made,
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 |
|---|---|---|
| TUBE BATHWrap Tube Baht (immersion) | Other | LED group Tube bath during the phototherapy, Tunnel group Tube bath during the phototherapy |
Primary outcome
Sample size
Time frame: 1-2 month
The sample size was composed of a total of 140 babies, which were determined according to Power Analysis and met the case selection criteria.
Divided groups
Time frame: 1 month
Thirty-five babies were randomly assigned to each group (Tunnel Group = experiment and control; LED Group = experiment and control).
Experiment difining and time
Time frame: 12 month
The babies in the experimental groups were given a tube bath at 6 and 12 hours after phototherapy started. On the other hand, the babies in the control groups were given routine cares in the units.
Measurement
Time frame: First, 6-12-24 hours for each nerwborn
Data were gathered 'Information and Registration Form', Neonatal Skin Risk Assessment Scale (NSRAS) and Neonatal Skin Condition Score (NSCS).
Biochemical measurement
Time frame: First, 6-12-24 hours for each nerwborn
Total serum bilirubin values obtained from patient files.
TSB Findings
Time frame: 10 month
When differences regarding decrease in 24-hour total serum bilirubin (TSB) levels were compared in all relevant experimental groups, statistically differences were observed (p˂ .001). In particular, the levels of bilirubin were listed as LED-trial, Tunnel-trial, Tunnel-control and LED-control, respectively. It is worthy to utter herein that the decline in TSB was more notable in bathing groups.
Skin care findings
Time frame: 10 month
Skin integrity and moisture balance were better in bathing groups than control groups, the best was in the Tunnel-experimental group and the worst was in the Tunnel-control group (p˂ .001).
Conclusion
Time frame: 12 month
Tube bath is suggested that decreasing total serum bilirubin level and maintaining skin integrity and moisture balance.
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 15 Oct 2024.
- BackgroundBagwell, G. A., & Steward, D. K. (2020). Hematologic System. Comprehensive Neonatal Nursing Care (6th ed.), Springer Publishing Company, 11C. New York, 315-335.
- BackgroundAssociation of Women's Health, Obstetric and Neonatal Nurses. (2018). Evidence-Based Clinical Practice Guideline: Neonatal Skin Care (4th ed.). Washington, DC.
- Background: PubMed 29223208Brogan J, Rapkin G. Implementing Evidence-Based Neonatal Skin Care With Parent-Performed, Delayed Immersion Baths. Nurs Womens Health. 2017 Dec;21(6):442-450. doi: 10.1016/j.nwh.2017.10.009.
- BackgroundDağ, Y. S., & Yayan, E. H. (2019). The Effect on Bilirubin Levels of Massage, Tub Bath, and Sponge Bath in Newborns with Hyperbilirubinemia: A Randomized ControlLed Trial. European Journal of Integrative Medicine, 27, 70-74.
- BackgroundKaplan, M., Wong, RJ., Burgis, JC., Sibley E., Stevensen, DK. (2020). Neonatal Jaundice and Liver Diseases, Martin RJ, Fanoroff AA, Walsh MC, Fanaroff and Martin's Neonatal-Perinatal Medicine in 11th Edition, Philadelphia, 91:1788-1852.
- BackgroundMohammadi Pirkashani, L., Asghari, G., Marofi, M., & Barekatain, B. (2017). Effect of Chicory Extract Bath on Neonatal Bilirubin Levels: A Randomized Clinical Trial Study. International Journal of Pediatrics, 5(12), 6679-6688.
- Background: PubMed 25844870Sherbiny HS, Youssef DM, Sherbini AS, El-Behedy R, Sherief LM. High-intensity light-emitting diode vs fluorescent tubes for intensive phototherapy in neonates. Paediatr Int Child Health. 2016 May;36(2):127-33. doi: 10.1179/2046905515Y.0000000006.
- Derived from this study: PubMed 38899824Ozdemir S, Balci S. The Effect of Tub Bathing on the Skin and Bilirubin Levels of Babies Receiving Tunnel and Light-Emitting Diode Phototherapies: A Randomized Controlled Trial. Adv Skin Wound Care. 2024 Jul 1;37(7):1-9. doi: 10.1097/ASW.0000000000000163.
- Individual participant dataSharing planned: No
Related trials for Newborn Jaundice
Recruiting
Abdominal Massage for Newborn Jaundice
Neonatal Jaundice
Active, not recruiting
Newborn Abdominal Massage to Prevent Hyperbilirubinemia
Newborn Jaundice
Not yet recruiting
Efficacy of Bifidobacterium Animalis Subsp. Lactis in the Treatment of Indirect Hyperbilirubinemia in Term Neonates
Indirect Hyperbilirubinemia
Not yet recruitingPhase 4
Comparison Of Fenofibrate Vs Phenobarbitone As Adjunct To Phototherapy In Reducing Total Serum Bilirubin In Indirect Hyperbilirubinemia In Neonates
Jaundice, Neonatal
Enrolling by invitation
Hat-Type Glasses Intervention in Phototherapy-Related Newborns
Neonatal Hyperbilirubinemia, Neonatal Jaundice
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 TUBE BATH in people with Newborn Jaundice, run by Istanbul University - Cerrahpasa 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 4 inclusion and 7 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 15 Oct 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 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?
Sample size (time frame: 1-2 month). The study lists 8 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 NCT04962113, which also lists 8 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 15 Oct 2024.