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Completed

NCT Number: NCT07106164

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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.

Treatment and study plan

total body massage

Procedure

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.

photo therapy

Device

neonates received phototherapy for the neonatal hyperbilirubinemia

Primary outcomes

  1. stool motions per day

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

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

  2. bilirubin level

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

    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.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

The Effect of Total Body Massage on Neonatal Jaundice in Preterm Neonates: A Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Aug 6, 2025
Registry last updated
Aug 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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