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Hyperbilirubinemia, NeonatalNCT05356273

The Effect of Massage on the Bilirubin Level in Term Infants Receiving Phototherapy

A study testing Baby massage in people with Hyperbilirubinemia, Neonatal, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Background: It has been reported in the current literature that massage has various positive physiological effects on the newborn. Also baby massage; It increases the collection and excretion of waste products such as bilirubin by accelerating the flow of blood, lymph and tissue fluids. 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?
Baby massage
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
61 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Oct 2021to 1 Jan 2022
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

  • Born between 37-42 gestational weeks
  • Birth weight between 2500-4000gr
  • 1st and 5th Apgar score between 7-10
  • Needing phototherapy treatment
  • Diagnosed with indirect hyperbilirubinemia 24 hours or more after birth
  • Orally fed
  • No health problems other than indirect hyperbilirubinemia
  • Newborns who has stable vital signs

Who cannot join

  • ABO blood incompatibility or Rh incompatibility
  • Diagnosed with direct hyperbilirubinemia
  • Newborns who has skin anomaly
  • Needing fluid replacement
  • Newborns with gastrointestinal disorders

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Istanbul University Cerrahpasa

    Istanbul

Other trials in Turkey (Türkiye)

About this study

Background: It has been reported in the current literature that massage has various positive physiological effects on the newborn. Also baby massage; It increases the collection and excretion of waste products such as bilirubin by accelerating the flow of blood, lymph and tissue fluids. Our aim is to investigate the effect of infant massage on hyperbilirubinemia in newborns receiving phototherapy.

Method: The population of the study consisted of babies who were hospitalized in Istanbul Haseki Training and Research Hospital Neonatal Intensive Care Unit between October 2021 and January 2022 and needed phototherapy. Transcutaneous bilirubin device and data collection form were used to obtain the data. 61 newborns who met the study criteria were randomly divided into experimental (n=30) and control (n=31) groups. Phototherapy was applied to all babies twice a day. In addition to phototherapy, infant massage was applied to the experimental group for 10 minutes just before the phototherapy. Bilirubin level measurements were made 2 hours after the end of phototherapy for both groups. Diaper changes for both groups were carried out 8 times a day, every 3 hours.

Being tested
Baby massage
Keywords
infant, baby massage, hyperbilirubinemia, bilirubin
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.

  • Baby massageProcedure or surgery

    Starting from the baby's face first, then the abdomen and chest, back, upper extremities and finally the lower extremities were massaged with semi-circular movements, respectively.

Study groups in NCT05356273
Study groupRoleWhat they receive
Massage GroupExperimentalThe incubator temperature was adjusted between 28-30 C, and it was administered while the baby was awake and one hour after feeding. Before the massage, the hands were washed and warmed. Just before each phototherapy application, 10-minute baby massage was performed by the researcher.Then phototherapy was applied.
Receives: Procedure: Baby massage
Control GroupNo interventionJust received phototherapy twice a day

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bilirubin levels

    decreasing bilirubin levels within intervention times

    Measured: 72 hours

Secondary outcomes (1)

  1. Stool frequency

    increasing stool frequency within intervention times

    Measured: 72 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 May 2022
  2. Study start1 Oct 2021
  3. Primary completion1 Jan 2022
  4. Study completion1 Jan 2022

Resources

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
Participant, Care provider
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05356273
Sponsor's protocol ID
2021/84
Status last verified
Sep 2022
First submitted
25 Apr 2022
Last updated
18 Oct 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Amos RC, Jacob H, Leith W. Jaundice in newborn babies under 28 days: NICE guideline 2016 (CG98). Arch Dis Child Educ Pract Ed. 2017 Aug;102(4):207-209. doi: 10.1136/archdischild-2016-311556. Epub 2017 Feb 8. No abstract available.

    PubMed 28179382

  • Anderson NB, Calkins KL. Neonatal Indirect Hyperbilirubinemia. Neoreviews. 2020 Nov;21(11):e749-e760. doi: 10.1542/neo.21-11-e749.

    PubMed 33139512

  • Basiri-Moghadam M, Basiri-Moghadam K, Kianmehr M, Jani S. The effect of massage on neonatal jaundice in stable preterm newborn infants: a randomized controlled trial. J Pak Med Assoc. 2015 Jun;65(6):602-6.

    PubMed 26060154

  • Mitra S, Rennie J. Neonatal jaundice: aetiology, diagnosis and treatment. Br J Hosp Med (Lond). 2017 Dec 2;78(12):699-704. doi: 10.12968/hmed.2017.78.12.699.

    PubMed 29240507

  • Olusanya BO, Kaplan M, Hansen TWR. Neonatal hyperbilirubinaemia: a global perspective. Lancet Child Adolesc Health. 2018 Aug;2(8):610-620. doi: 10.1016/S2352-4642(18)30139-1. Epub 2018 Jun 28.

    PubMed 30119720

  • Pace EJ, Brown CM, DeGeorge KC. Neonatal hyperbilirubinemia: An evidence-based approach. J Fam Pract. 2019 Jan/Feb;68(1):E4-E11.

    PubMed 30724909

  • Montgomery P, Grant S, Mayo-Wilson E, Macdonald G, Michie S, Hopewell S, Moher D; CONSORT-SPI Group. Reporting randomised trials of social and psychological interventions: the CONSORT-SPI 2018 Extension. Trials. 2018 Jul 31;19(1):407. doi: 10.1186/s13063-018-2733-1.

    PubMed 30060754

  • Ahmadipour S, Mardani M, Mohsenzadeh A, Baharvand P, Nazeri MG. The Lowering of Bilirubin Levels in Full-Term Newborns by the Effect of Combined Massage Therapy and Phototherapy Practice. Am J Perinatol. 2024 May;41(S 01):e3420-e3424. doi: 10.1055/s-0039-1685493. Epub 2019 Apr 18.

    PubMed 30999382

  • Dalili H, Sheikhi S, Shariat M, Haghnazarian E. Effects of baby massage on neonatal jaundice in healthy Iranian infants: A pilot study. Infant Behav Dev. 2016 Feb;42:22-6. doi: 10.1016/j.infbeh.2015.10.009. Epub 2015 Nov 29.

    PubMed 26646074

  • Eghbalian F, Rafienezhad H, Farmal J. The lowering of bilirubin levels in patients with neonatal jaundice using massage therapy: A randomized, double-blind clinical trial. Infant Behav Dev. 2017 Nov;49:31-36. doi: 10.1016/j.infbeh.2017.05.002. Epub 2017 Jul 6.

    PubMed 28688960

  • Garg BD, Kabra NS, Balasubramanian H. Role of massage therapy on reduction of neonatal hyperbilirubinemia in term and preterm neonates: a review of clinical trials. J Matern Fetal Neonatal Med. 2019 Jan;32(2):301-309. doi: 10.1080/14767058.2017.1376316. Epub 2017 Sep 13.

    PubMed 28870134

  • Gozen D, Yilmaz OE, Dur S, Caglayan S, Tastekin A. Transcutaneous bilirubin levels of newborn infants performed abdominal massage: A randomized controlled trial. J Spec Pediatr Nurs. 2019 Apr;24(2):e12237. doi: 10.1111/jspn.12237. Epub 2019 Feb 28.

    PubMed 30817090

  • Korkmaz G, Esenay FI. Effects of Massage Therapy on Indirect Hyperbilirubinemia in Newborns Who Receive Phototherapy. J Obstet Gynecol Neonatal Nurs. 2020 Jan;49(1):91-100. doi: 10.1016/j.jogn.2019.11.004. Epub 2019 Dec 6.

    PubMed 31812490

  • Lei M, Liu T, Li Y, Liu Y, Meng L, Jin C. Effects of massage on newborn infants with jaundice: A meta-analysis. Int J Nurs Sci. 2018 Jan 31;5(1):89-97. doi: 10.1016/j.ijnss.2018.01.004. eCollection 2018 Jan 10.

    PubMed 31406807

  • Lin 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 26607061

Questions about this trial

What is this clinical trial studying?

A study testing Baby massage in people with Hyperbilirubinemia, Neonatal, 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 8 inclusion and 5 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 18 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?

Bilirubin levels (time frame: 72 hours). 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 NCT05356273, which also lists 17 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 18 Oct 2024.

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