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Clinical Trials/NCT05260138
NCT05260138
Completed
Not Applicable

Effect of Massaging on Bilirubin Level Among Full Term Neonates With Hyperbilirubinemia Under Phototherapy.

Alexandria University1 site in 1 country60 target enrollmentAugust 20, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hyperbilirubinemia, Neonatal
Sponsor
Alexandria University
Enrollment
60
Locations
1
Primary Endpoint
Bilirubin level
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

This study aimed to investigate the effect of bundling gentle body massage along with regular position change on bilirubin level and clinical outcomes among full-term neonates with hyperbilirubinemia under phototherapy.

Hypothesis

Full-term neonates with hyperbilirubinemia who receive gentle body massage along with regular position change exhibit less bilirubin level and better clinical outcomes than those who don't.

Detailed Description

A quasi-experimental study was carried out in the NICU of XX. Sixty full-term neonates were randomly assigned to two equal groups. The control group received the conventional NICU care of infants undergoing phototherapy. Phototherapy was given by single Blue LEDs emitting light in a narrow spectrum (450-470 nm). Initially, phototherapy lamps were checked and adjusted at the height of 30 cm from the neonates who were kept naked in the incubator/crib except for the reproductive organs with shielded eyes. The neonates were positioned supine under the phototherapy. The treatment was given continuously, except while feeding and nursing for 30 minutes every 3 hours. The neonates' skin was cleaned with warm water without applying any sorts of ointments oils or creams. They were also observed for signs of dehydration. The intervention group received all basic routine care in addition to regular position change from supine to laterals under the phototherapy every two hours. They also received gentle body massage

Registry
clinicaltrials.gov
Start Date
August 20, 2021
End Date
December 18, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Zohour Ibrahim Mahmoud Rashwan

Lecturer

Alexandria University

Eligibility Criteria

Inclusion Criteria

  • Full-term
  • receive enteral feeding (breast, bottle, or mixed feeding, gavage)
  • Newly admitted

Exclusion Criteria

  • Required exchange transfusion
  • Required mechanical ventilation
  • Has acute phase of circulatory insufficiency
  • Hemolytic disease
  • Neurological disorders
  • Congenital anomalies
  • Neonatal sepsis Diarrhea

Outcomes

Primary Outcomes

Bilirubin level

Time Frame: After 3 days

The researchers recorded the neonates' Bilirubin level from the laboratory results

Secondary Outcomes

  • Percentage of the consumed milk(After 3 days)
  • Length of hospital stay(After 10 days)
  • Frequency of stool(After 3 days)
  • daily weight(After 3 days)

Study Sites (1)

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