Tactile and Kinaesthetic Stimulation in Neonates With Hyperbilirubinaemia
Primary Purpose
Neonatal Hyperbilirubinemia
Status
Recruiting
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Massage therapy
Kinaesthetic stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Neonatal Hyperbilirubinemia
Eligibility Criteria
- New born in Neonatal Intensive Care Unit
- Stable vitals
- Full Term and Preterm neonates
- Gestational age 34 weeks to 40 weeks
- Birth weight -1800 - 2500 g
- APGAR Score at birth of 8 -10
- Total serum bilirubin levels > 5mg/dL
Sites / Locations
- Civil HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental Group
Control Group
Arm Description
Neonates recruited in experimental group will receive massage therapy and kinaesthetic stimulation for 15 minutes along with phototherapy for consecutive days . It will be given in three phases first massage therapy will be given for 5 minutes, followed by movement of limbs for 5 minutes and then again massage therapy will be repeated for 5 minutes.
Neonates recruited in control group will receive phototherapy alone along with regular care
Outcomes
Primary Outcome Measures
Total Serum Bilirubin (TSB)
It will measure total bilirubin level in blood of neonates
Transcutaneous Bilirubin (TcB)
Transcutaneous Bilirubin will measure neonatal jaundice.
Weight Gain
Weight gain will evaluate the change in neonatal weight
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05077787
Brief Title
Tactile and Kinaesthetic Stimulation in Neonates With Hyperbilirubinaemia
Official Title
Tactile and Kinaesthetic Stimulation in Preterm Neonates With Hyperbilirubinaemia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
November 30, 2022 (Anticipated)
Study Completion Date
August 10, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Asir John Samuel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Hyperbilirubinemia is the commonest problem seen in neonates, owing to severe complications in lifetime. The study design of the study is pretest - posttest experimental design. Convenience Sampling will be used for recruiting the neonates. In study neonates will be selected according to the selection criteria and will be allocated into two groups in 1: 1 ratio, Intervention group - neonates will receive tactile and kinesthetic stimulation for 15 minutes for 3 consecutive days, 1 hours after feed twice daily along with Phototherapy, Control group - Phototherapy alone will be given. Total serum bilirubin and weight gain will be assessed as outcome measure daily once. Transcutaneous bilirubin will be assessed before and after every intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Hyperbilirubinemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
97 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
Neonates recruited in experimental group will receive massage therapy and kinaesthetic stimulation for 15 minutes along with phototherapy for consecutive days . It will be given in three phases first massage therapy will be given for 5 minutes, followed by movement of limbs for 5 minutes and then again massage therapy will be repeated for 5 minutes.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Neonates recruited in control group will receive phototherapy alone along with regular care
Intervention Type
Other
Intervention Name(s)
Massage therapy
Intervention Description
Massage therapy includes stroking, kneading, rolling, tapping, vibration and effleurage over the face, chest ,abdomen and back. Massage therapy will be given for 5 minutes and will be repeated twice.
Intervention Type
Other
Intervention Name(s)
Kinaesthetic stimulation
Intervention Description
Kinaesthetic stimulation includes passive flexion and extension movements of shoulder joint, elbow joint, hip joint, knee joint and both lower limbs together. It will be given for 5 minutes in each intervention
Primary Outcome Measure Information:
Title
Total Serum Bilirubin (TSB)
Description
It will measure total bilirubin level in blood of neonates
Time Frame
Changes in the Total Serum Bilirubin level will be measured at baseline and at the end of three days intervention
Title
Transcutaneous Bilirubin (TcB)
Description
Transcutaneous Bilirubin will measure neonatal jaundice.
Time Frame
Changes in the Transcutaneous Bilirubin level will be measured daily for three days before and after intervention
Title
Weight Gain
Description
Weight gain will evaluate the change in neonatal weight
Time Frame
Changes in the weight will be measured at baseline and at the end of three days intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
24 Hours
Maximum Age & Unit of Time
72 Hours
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
New born in Neonatal Intensive Care Unit
Stable vitals
Full Term and Preterm neonates
Gestational age 34 weeks to 40 weeks
Birth weight -1800 - 2500 g
APGAR Score at birth of 8 -10
Total serum bilirubin levels > 5mg/dL
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Saumya Kothiyal, PhD scholar
Phone
8650987709
Email
saumyakothiyal28@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Asir John Samuel, PhD
Phone
8059930222
Email
asirjohnsamuel@mmumullana.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saumya Kothiyal, MPT
Organizational Affiliation
Maharishi Markendeshawar (Deemed to be University)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Civil Hospital
City
Ropar
State/Province
Punjab
ZIP/Postal Code
140001
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Gurpreet Kaur, MD
Phone
8427766998
Email
saumyakothiyal28@gmail.com
First Name & Middle Initial & Last Name & Degree
Saumya Kothiyal, MPT (PhD)
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33014346
Citation
Rahmawati D, Sampurna MTA, Etika R, Utomo MT, Bos AF. Transcutaneous bilirubin level to predict hyperbilirubinemia in preterm neonates. F1000Res. 2020 Apr 28;9:300. doi: 10.12688/f1000research.22264.2. eCollection 2020.
Results Reference
background
PubMed Identifier
26607061
Citation
Lin CH, Yang HC, Cheng CS, Yen CE. Effects of infant massage on jaundiced neonates undergoing phototherapy. Ital J Pediatr. 2015 Nov 25;41:94. doi: 10.1186/s13052-015-0202-y.
Results Reference
background
PubMed Identifier
31174382
Citation
Field T. Pediatric Massage Therapy Research: A Narrative Review. Children (Basel). 2019 Jun 6;6(6):78. doi: 10.3390/children6060078.
Results Reference
background
PubMed Identifier
28368368
Citation
Niemi AK. Review of Randomized Controlled Trials of Massage in Preterm Infants. Children (Basel). 2017 Apr 3;4(4):21. doi: 10.3390/children4040021.
Results Reference
background
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Tactile and Kinaesthetic Stimulation in Neonates With Hyperbilirubinaemia
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