Bundling Gentle Body Massage Along With Regular Position Change Under Phototherapy
Effect of Massaging on Bilirubin Level Among Full Term Neonates With Hyperbilirubinemia Under Phototherapy.
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 20, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 17, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 18, 2021
CompletedFirst Submitted
Initial submission to the registry
February 18, 2022
CompletedFirst Posted
Study publicly available on registry
March 2, 2022
CompletedMarch 2, 2022
February 1, 2022
4 months
February 18, 2022
February 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Bilirubin level
The researchers recorded the neonates' Bilirubin level from the laboratory results
After 3 days
Secondary Outcomes (4)
Percentage of the consumed milk
After 3 days
Frequency of stool
After 3 days
daily weight
After 3 days
Length of hospital stay
After 10 days
Study Arms (2)
The intervention group
EXPERIMENTALreceived all basic routine care in addition to regular position change and gentle body massage
The control group
ACTIVE COMPARATORreceived the conventional NICU care
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Full-term
- receive enteral feeding (breast, bottle, or mixed feeding, gavage)
- Newly admitted
You may not qualify if:
- Required exchange transfusion
- Required mechanical ventilation
- Has acute phase of circulatory insufficiency
- Hemolytic disease
- Neurological disorders
- Congenital anomalies
- Neonatal sepsis Diarrhea
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Nursing
Alexandria, 56321, Egypt
Related Publications (5)
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.
PMID: 29631455BACKGROUNDChen 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.
PMID: 16306190BACKGROUNDDonneborg 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.
PMID: 20528799BACKGROUNDField 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.
PMID: 3754633BACKGROUNDKato 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.
PMID: 31473126BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer
Study Record Dates
First Submitted
February 18, 2022
First Posted
March 2, 2022
Study Start
August 20, 2021
Primary Completion
December 17, 2021
Study Completion
December 18, 2021
Last Updated
March 2, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share