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CompletedNCT07106164Updated Aug 6, 2025

The Effect of Total Body Massage on Neonatal Jaundice in Preterm Neonates

An interventional study of total body massage and photo therapy in Preterm and Neonatal Hyperbilirubinemia, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 1 Hour to 30 Days. Per ClinicalTrials.gov, last updated 2025-08-06.

Sponsored by Ain Shams University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 2 years 1 month after the study started (first participant enrolled Jun 2023, registered Jul 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
1 Hour to 30 Days
Sex
All
01

Study summary

Different methods are subscribed for the lowering of the bilirubin level, the most important of which are: exchange transfusion, phototherapy and using pharmacological agents. However, the remedial practice that has become most common for curing hyperbilirubinemia is phototherapy, has several side-effects. Thus there is constant research going on to find a substitute for phototherapy or to lessen its duration such as total body massage.

Read the detailed description

Neonatal jaundice or hyperbilirubinemia is mostly cured (20% cases) though it can still prove hazardous and need medical intervention The most life-threatening case arising from this condition is kernicterus. Unfortunately, this condition is fatal in 75% cases and 80% of those who stay alive do not escape unscathed and exhibit problems related to the nervous system. Thus a timely cure of neonatal hyperbilirubinemia has become a major preventive measure Different methods are subscribed for the lowering of the bilirubin level, the most important of which are: exchange transfusion, phototherapy and using pharmacological agents . However, the most used treatment for curing hyperbilirubinemia is phototherapy, which has several side-effects ranging from doing harm to the cornea and the genital region to causing dehydration, diarrhoea and bronze kid syndrome. Thus there is constant research going on to find a substitute for phototherapy or to lessen the duration of the same.

Infant massage is a traditional practice in several regions of the world, to be more precise, in the cultures of Africa and Asia. A survey done recently in Bangladesh showed that 96% of the caretakers of neonates engaged in massaging the whole body of the infant one to three times a day. Healthcare practitioners in the West have also started to show interest in infant massage, especially, as an interventional measure for infants in neonatal intensive care units (NICUs) where mostly the environment is stressful and lacks adequate tactile stimulation. In order to promote infant growth, more parents and caretakers of low-risk babies are being trained in massage in the Western world studies have showed that massage stimulation encourages the passing of more meconium containing bilirubin by newborns and suggested that neonate massage can contribute toward the prevention of neonatal jaundice and the controlling of bilirubin to within normal range Taking all the above into account, this research was carried out with the aim of studying the effect of massage, using Field's Technique, on neonatal jaundice in preterm newborns on phototherapy.

02

Conditions studied

  • Preterm
  • Neonatal Hyperbilirubinemia
03

In context

Premature Birth

2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.

This study's enrollment of 40 is below the median of 84 across 1,689 interventional studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Hour to 30 Days
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Preterm neonates from 32 to 36 wks gestational age.
  • Hyperbilirubinemia needing phototherapy.

Exclusion criteria

Exclusion Criteria:

  • Serious congenital malformation.
  • Fetal hydrops.
  • Hemolytic jaundice.
  • Confirmed intrauterine infection (toxoplasmosis, rubella, cytomegalovirus, syphilis and herpes).
  • Bilirubin level near exchange transfusion level.
  • Any skeletal abnormality or joint affection.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    total body massage

    patients received total body massage and phototherapy

    Procedure: total body massage · Device: photo therapy

  • Active comparator
    control

    neonates received phototherapy only

    Device: photo therapy

Interventions

  • Proceduretotal body massage

    Massage was done using the Field's Technique after starting phototherapy till discontinuation of phototherapy for 15 - 20 minutes, three times daily 1 hour after the morning, mid- day feeds and at night.

  • Devicephoto therapy

    neonates received phototherapy for the neonatal hyperbilirubinemia

06

What researchers measure

Primary outcomes

  1. stool motions per day

    Number of times the newborn passes stool will be recorded daily throughout phototherapy and total body massage

    Time frame: baseline and daily throughout study completion, an average of 3 months

  2. bilirubin level

    Serum bilirubin recorded on the start of treatment before any massage intervention and regular follow up till discontinuation of phototherapy and rebound level upon stoppage of phototherapy.

    Time frame: baseline and throughout study completion, an average of 3 month

07

Study locations

1 site
  • Childrens Hospital Ain Shams University Hospitals
    Cairo, Egypt
08

References and documents

Individual participant data

Plan to share: Yes — data can be shared upon reasonable request from the corresponding author

Supporting information: Study protocol, Sap

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07106164
Lead sponsor
Ain Shams University
Responsible party
Mariam Ibrahim (assistant professor of pediatrics and neonatology , Ain Shams University, Ain Shams University) — Principal investigator
First posted
Aug 6, 2025
Start date
Jun 1, 2023
Primary completion
Dec 1, 2023
Completion
Jun 1, 2024
Last update
Aug 6, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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