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

NCT07106164 | Completed DMC

• 1 other identifier: total body massage & jaundice
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm; Neonatal Hyperbilirubinemia

Outcome Measures

Primary Outcomes (2)

• stool motions per day

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

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

• 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.

  baseline and throughout study completion, an average of 3 month

Study Arms (2)

total body massage

EXPERIMENTAL

patients received total body massage and phototherapy

Procedure: total body massage; Device: photo therapy

control

ACTIVE COMPARATOR

neonates received phototherapy only

Device: photo therapy

Interventions

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.

total body massage

photo therapy DEVICE

neonates received phototherapy for the neonatal hyperbilirubinemia

control; total body massage

Eligibility Criteria

• Age: 1 Hour - 30 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Childrens Hospital Ain Shams University Hospitals

Cairo, Egypt

Location

MeSH Terms

Conditions

Premature Birth; Hyperbilirubinemia, Neonatal

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor of pediatrics and neonatology , Ain Shams University

Study Record Dates

• First Submitted: July 17, 2025
• First Posted: August 6, 2025
• Study Start: June 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: June 1, 2024
• Last Updated: August 6, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: after publication

Locations

EG (1)