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Bundling Gentle Body Massage Along With Regular Position Change Under Phototherapy

Primary Purpose

Hyperbilirubinemia, Neonatal

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Gentle Body message
Routine NICU Care
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hyperbilirubinemia, Neonatal focused on measuring Hyperbilirubinemia, neonatal, Massage Therapy, Bilirubin, Stool frequency, Length of Hospital Stay

Eligibility Criteria

1 Day - 28 Days (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Faculty of Nursing

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

The intervention group

The control group

Arm Description

received all basic routine care in addition to regular position change and gentle body massage

received the conventional NICU care

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Percentage of the consumed milk
The researchers calculated the percentage of the consumed milk by dividing the actual amount sucked by the neonate on the prescribed amount and multiplied by 100
Frequency of stool
The researchers counted number of neonates' stool passage per day
daily weight
The researchers measured the neonates' weight daily using the same scale
Length of hospital stay
the researchers obtained the neonates' length of hospital stay from admission to discharge

Full Information

First Posted
February 18, 2022
Last Updated
February 18, 2022
Sponsor
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT05260138
Brief Title
Bundling Gentle Body Massage Along With Regular Position Change Under Phototherapy
Official Title
Effect of Massaging on Bilirubin Level Among Full Term Neonates With Hyperbilirubinemia Under Phototherapy.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
August 20, 2021 (Actual)
Primary Completion Date
December 17, 2021 (Actual)
Study Completion Date
December 18, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperbilirubinemia, Neonatal
Keywords
Hyperbilirubinemia, neonatal, Massage Therapy, Bilirubin, Stool frequency, Length of Hospital Stay

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The intervention group
Arm Type
Experimental
Arm Description
received all basic routine care in addition to regular position change and gentle body massage
Arm Title
The control group
Arm Type
Active Comparator
Arm Description
received the conventional NICU care
Intervention Type
Other
Intervention Name(s)
Gentle Body message
Intervention Description
The intervention group received gentle body massage twice/day and position change from supine to lateral every two hours under the phototherapy for three consecutive days in addition to routine NICU care.
Intervention Type
Other
Intervention Name(s)
Routine NICU Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Bilirubin level
Description
The researchers recorded the neonates' Bilirubin level from the laboratory results
Time Frame
After 3 days
Secondary Outcome Measure Information:
Title
Percentage of the consumed milk
Description
The researchers calculated the percentage of the consumed milk by dividing the actual amount sucked by the neonate on the prescribed amount and multiplied by 100
Time Frame
After 3 days
Title
Frequency of stool
Description
The researchers counted number of neonates' stool passage per day
Time Frame
After 3 days
Title
daily weight
Description
The researchers measured the neonates' weight daily using the same scale
Time Frame
After 3 days
Title
Length of hospital stay
Description
the researchers obtained the neonates' length of hospital stay from admission to discharge
Time Frame
After 10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
28 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Faculty of Nursing
City
Alexandria
ZIP/Postal Code
56321
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29631455
Citation
Zhang M, Wang L, Wang Y, Tang J. The influence of massage on neonatal hyperbilirubinemia: a meta-analysis of randomized controlled trials. J Matern Fetal Neonatal Med. 2019 Sep;32(18):3109-3114. doi: 10.1080/14767058.2018.1455183. Epub 2018 Apr 9.
Results Reference
background
PubMed Identifier
16306190
Citation
Chen A, Du L, Xu Y, Chen L, Wu Y. The effect of blue light exposure on the expression of circadian genes: bmal1 and cryptochrome 1 in peripheral blood mononuclear cells of jaundiced neonates. Pediatr Res. 2005 Dec;58(6):1180-4. doi: 10.1203/01.pdr.0000183663.98446.05.
Results Reference
background
PubMed Identifier
20528799
Citation
Donneborg ML, Knudsen KB, Ebbesen F. Effect of infants' position on serum bilirubin level during conventional phototherapy. Acta Paediatr. 2010 Aug;99(8):1131-4. doi: 10.1111/j.1651-2227.2010.01885.x. Epub 2010 Jun 2.
Results Reference
background
PubMed Identifier
3754633
Citation
Field TM, Schanberg SM, Scafidi F, Bauer CR, Vega-Lahr N, Garcia R, Nystrom J, Kuhn CM. Tactile/kinesthetic stimulation effects on preterm neonates. Pediatrics. 1986 May;77(5):654-8.
Results Reference
background
PubMed Identifier
31473126
Citation
Kato S, Iwata O, Yamada Y, Kakita H, Yamada T, Nakashima H, Sugiura T, Suzuki S, Togari H. Standardization of phototherapy for neonatal hyperbilirubinemia using multiple-wavelength irradiance integration. Pediatr Neonatol. 2020 Feb;61(1):100-105. doi: 10.1016/j.pedneo.2019.07.002. Epub 2019 Aug 12.
Results Reference
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Bundling Gentle Body Massage Along With Regular Position Change Under Phototherapy

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