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

NCT ID: NCT07106164

Last Updated: 2025-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2024-06-01

Brief 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.

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.

Conditions

Preterm; Neonatal Hyperbilirubinemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

total body massage

patients received total body massage and phototherapy

Group Type: EXPERIMENTAL

total body massage

Intervention Type: 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

Intervention Type: DEVICE

neonates received phototherapy for the neonatal hyperbilirubinemia

control

neonates received phototherapy only

Group Type: ACTIVE_COMPARATOR

photo therapy

Intervention Type: DEVICE

neonates received phototherapy for the neonatal hyperbilirubinemia

Interventions

total 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.

Intervention Type: PROCEDURE

photo therapy

neonates received phototherapy for the neonatal hyperbilirubinemia

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Hour
• Maximum Eligible Age: 30 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Mariam Ibrahim

assistant professor of pediatrics and neonatology , Ain Shams University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Childrens Hospital Ain Shams University Hospitals

Cairo, , Egypt

Countries

Egypt

Other Identifiers

total body massage & jaundice

Identifier Type: -

Identifier Source: org_study_id