Hyperbilirubinemia, NeonatalNCT05260138
Bundling Gentle Body Massage Along With Regular Position Change Under Phototherapy
A study testing Gentle Body message and Routine NICU Care in people with Hyperbilirubinemia, Neonatal, run by Alexandria University at 1 site in Egypt.
Trial summary
This study aimed to investigate the effect of bundling gentle body massage along with regular position change on bilirubin level and clinical outcomes among full-term neonates with hyperbilirubinemia under phototherapy. Read more about this study
- Who is it for?
- Ages 1 day to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Hyperbilirubinemia, Neonatal
- What is being tested?
- Gentle Body message and Routine NICU Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Aug 2021to 18 Dec 2021
- 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 day to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Full-term
- receive enteral feeding (breast, bottle, or mixed feeding, gavage)
- Newly admitted
Who cannot join
- Required exchange transfusion
- Required mechanical ventilation
- Has acute phase of circulatory insufficiency
- Hemolytic disease
- Neurological disorders
- Congenital anomalies
- Neonatal sepsis Diarrhea
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Massaging on Bilirubin Level Among Full Term Neonates With Hyperbilirubinemia Under Phototherapy.
This study aimed to investigate the effect of bundling gentle body massage along with regular position change on bilirubin level and clinical outcomes among full-term neonates with hyperbilirubinemia under phototherapy.
Hypothesis
Full-term neonates with hyperbilirubinemia who receive gentle body massage along with regular position change exhibit less bilirubin level and better clinical outcomes than those who don't.
Read the detailed description
A quasi-experimental study was carried out in the NICU of XX. Sixty full-term neonates were randomly assigned to two equal groups.
The control group received the conventional NICU care of infants undergoing phototherapy. Phototherapy was given by single Blue LEDs emitting light in a narrow spectrum (450-470 nm). Initially, phototherapy lamps were checked and adjusted at the height of 30 cm from the neonates who were kept naked in the incubator/crib except for the reproductive organs with shielded eyes. The neonates were positioned supine under the phototherapy. The treatment was given continuously, except while feeding and nursing for 30 minutes every 3 hours. The neonates' skin was cleaned with warm water without applying any sorts of ointments oils or creams. They were also observed for signs of dehydration.
The intervention group received all basic routine care in addition to regular position change from supine to laterals under the phototherapy every two hours. They also received gentle body massage
- Conditions
- Hyperbilirubinemia, Neonatal
- Being tested
- Gentle Body message, Routine NICU Care
- Keywords
- Hyperbilirubinemia, neonatal, Massage Therapy, Bilirubin, Stool frequency, Length of Hospital Stay
- Medical subject headings
- Hyperbilirubinemia, Neonatal, Hyperbilirubinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gentle Body messageOther
The intervention group received gentle body massage twice/day and position change from supine to lateral every two hours under the phototherapy for three consecutive days in addition to routine NICU care.
Routine NICU CareOther
received the conventional NICU care of infants undergoing phototherapy. Phototherapy was given by single Blue LEDs emitting light in a narrow spectrum (450-470 nm). Initially, phototherapy lamps were checked and adjusted at the height of 30 cm from the neonates who were kept naked in the incubator/crib except for the reproductive organs with shielded eyes. The neonates were positioned supine under the phototherapy. The treatment was given continuously, except while feeding and nursing for 30 minutes every 3 hours. The neonates' skin was cleaned with warm water without applying any sorts of ointments oils or creams. They were also observed for signs of dehydration.
| Study group | Role | What they receive |
|---|---|---|
| The intervention group | Experimental | received all basic routine care in addition to regular position change and gentle body massage Receives: Other: Gentle Body message |
| The control group | Active comparator | received the conventional NICU care Receives: Other: Routine NICU Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bilirubin level
The researchers recorded the neonates' Bilirubin level from the laboratory results
Measured: After 3 days
Secondary outcomes (4)
Percentage of the consumed milk
The researchers calculated the percentage of the consumed milk by dividing the actual amount sucked by the neonate on the prescribed amount and multiplied by 100
Measured: After 3 days
Frequency of stool
The researchers counted number of neonates' stool passage per day
Measured: After 3 days
daily weight
The researchers measured the neonates' weight daily using the same scale
Measured: After 3 days
Length of hospital stay
the researchers obtained the neonates' length of hospital stay from admission to discharge
Measured: After 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start20 Aug 2021
- Primary completion17 Dec 2021
- Study completion18 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hyperbilirubinemia, NeonatalStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zohour Ibrahim Mahmoud Rashwan, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05260138
- Sponsor's protocol ID
- 170301221
- Status last verified
- Feb 2022
- First submitted
- 18 Feb 2022
- Last updated
- 2 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang M, Wang L, Wang Y, Tang J. The influence of massage on neonatal hyperbilirubinemia: a meta-analysis of randomized controlled trials. J Matern Fetal Neonatal Med. 2019 Sep;32(18):3109-3114. doi: 10.1080/14767058.2018.1455183. Epub 2018 Apr 9.
PubMed 29631455Chen A, Du L, Xu Y, Chen L, Wu Y. The effect of blue light exposure on the expression of circadian genes: bmal1 and cryptochrome 1 in peripheral blood mononuclear cells of jaundiced neonates. Pediatr Res. 2005 Dec;58(6):1180-4. doi: 10.1203/01.pdr.0000183663.98446.05.
PubMed 16306190Donneborg ML, Knudsen KB, Ebbesen F. Effect of infants' position on serum bilirubin level during conventional phototherapy. Acta Paediatr. 2010 Aug;99(8):1131-4. doi: 10.1111/j.1651-2227.2010.01885.x. Epub 2010 Jun 2.
PubMed 20528799Field TM, Schanberg SM, Scafidi F, Bauer CR, Vega-Lahr N, Garcia R, Nystrom J, Kuhn CM. Tactile/kinesthetic stimulation effects on preterm neonates. Pediatrics. 1986 May;77(5):654-8.
PubMed 3754633Kato S, Iwata O, Yamada Y, Kakita H, Yamada T, Nakashima H, Sugiura T, Suzuki S, Togari H. Standardization of phototherapy for neonatal hyperbilirubinemia using multiple-wavelength irradiance integration. Pediatr Neonatol. 2020 Feb;61(1):100-105. doi: 10.1016/j.pedneo.2019.07.002. Epub 2019 Aug 12.
PubMed 31473126
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Massaging on Bilirubin Level Among Full Term Neonates With Hyperbilirubinemia Under Phototherapy.
- ClinicalTrials.gov ID
- NCT05260138
- Acronym / sponsor ID
- 170301221
- Conditions
- Hyperbilirubinemia, Neonatal
- Keywords
- Hyperbilirubinemia, neonatal, Massage Therapy, Bilirubin, Stool frequency, Length of Hospital Stay
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 20 Aug 2021 (actual)
- Primary completion
- 17 Dec 2021 (actual)
- Study completion
- 18 Dec 2021 (actual)
- First posted
- 2 Mar 2022 (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.
This study aimed to investigate the effect of bundling gentle body massage along with regular position change on bilirubin level and clinical outcomes among full-term neonates with hyperbilirubinemia under phototherapy.
Hypothesis
Full-term neonates with hyperbilirubinemia who receive gentle body massage along with regular position change exhibit less bilirubin level and better clinical outcomes than those who don't.
Detailed description
A quasi-experimental study was carried out in the NICU of XX. Sixty full-term neonates were randomly assigned to two equal groups.
The control group received the conventional NICU care of infants undergoing phototherapy. Phototherapy was given by single Blue LEDs emitting light in a narrow spectrum (450-470 nm). Initially, phototherapy lamps were checked and adjusted at the height of 30 cm from the neonates who were kept naked in the incubator/crib except for the reproductive organs with shielded eyes. The neonates were positioned supine under the phototherapy. The treatment was given continuously, except while feeding and nursing for 30 minutes every 3 hours. The neonates' skin was cleaned with warm water without applying any sorts of ointments oils or creams. They were also observed for signs of dehydration.
The intervention group received all basic routine care in addition to regular position change from supine to laterals under the phototherapy every two hours. They also received gentle body massage
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The intervention group | Experimental | Other: Gentle Body messagereceived all basic routine care in addition to regular position change and gentle body massage |
| The control group | Active comparator | Other: Routine NICU Carereceived the conventional NICU care |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Full-term
- receive enteral feeding (breast, bottle, or mixed feeding, gavage)
- Newly admitted
Key exclusion criteria (7 listed)
- Required exchange transfusion
- Required mechanical ventilation
- Has acute phase of circulatory insufficiency
- Hemolytic disease
- Neurological disorders
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 |
|---|---|---|
| Gentle Body messageThe intervention group received gentle body massage twice/day and position change from supine to lateral every two hours under the phototherapy for three consecutive days in addition to routine NICU care. | Other | The intervention group |
| Routine NICU Carereceived the conventional NICU care of infants undergoing phototherapy. Phototherapy was given by single Blue LEDs emitting light in a narrow spectrum (450-470 nm). Initially, phototherapy lamps were checked and adjusted at the height of 30 cm from the neonates who were kept naked in the incubator/crib except for the reproductive organs with shielded eyes. The neonates were positioned supine under the phototherapy. The treatment was given continuously, except while feeding and nursing for 30 minutes every 3 hours. The neonates' skin was cleaned with warm water without applying any sorts of ointments oils or creams. They were also observed for signs of dehydration. | Other | The control group |
Primary outcome
Bilirubin level
Time frame: After 3 days
The researchers recorded the neonates' Bilirubin level from the laboratory results
4 secondary outcomes
Percentage of the consumed milk
Time frame: After 3 days
Frequency of stool
Time frame: After 3 days
daily weight
Time frame: After 3 days
Length of hospital stay
Time frame: After 10 days
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 2 Mar 2022.
- Background: PubMed 29631455Zhang M, Wang L, Wang Y, Tang J. The influence of massage on neonatal hyperbilirubinemia: a meta-analysis of randomized controlled trials. J Matern Fetal Neonatal Med. 2019 Sep;32(18):3109-3114. doi: 10.1080/14767058.2018.1455183. Epub 2018 Apr 9.
- Background: PubMed 16306190Chen A, Du L, Xu Y, Chen L, Wu Y. The effect of blue light exposure on the expression of circadian genes: bmal1 and cryptochrome 1 in peripheral blood mononuclear cells of jaundiced neonates. Pediatr Res. 2005 Dec;58(6):1180-4. doi: 10.1203/01.pdr.0000183663.98446.05.
- Background: PubMed 20528799Donneborg ML, Knudsen KB, Ebbesen F. Effect of infants' position on serum bilirubin level during conventional phototherapy. Acta Paediatr. 2010 Aug;99(8):1131-4. doi: 10.1111/j.1651-2227.2010.01885.x. Epub 2010 Jun 2.
- Background: PubMed 3754633Field TM, Schanberg SM, Scafidi F, Bauer CR, Vega-Lahr N, Garcia R, Nystrom J, Kuhn CM. Tactile/kinesthetic stimulation effects on preterm neonates. Pediatrics. 1986 May;77(5):654-8.
- Background: PubMed 31473126Kato S, Iwata O, Yamada Y, Kakita H, Yamada T, Nakashima H, Sugiura T, Suzuki S, Togari H. Standardization of phototherapy for neonatal hyperbilirubinemia using multiple-wavelength irradiance integration. Pediatr Neonatol. 2020 Feb;61(1):100-105. doi: 10.1016/j.pedneo.2019.07.002. Epub 2019 Aug 12.
- 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 Gentle Body message and Routine NICU Care in people with Hyperbilirubinemia, Neonatal, run by Alexandria 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 3 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 2 Mar 2022. 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?
Bilirubin level (time frame: After 3 days). 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 NCT05260138, which also lists 5 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 2 Mar 2022.