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Effect of Tactile-Kinesthetic Stimulation on Preterm Neonates

Primary Purpose

Infant, Premature, Diseases

Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Tactile-kinesthetic Stimulation
Placebo
Sponsored by
Indonesia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Infant, Premature, Diseases focused on measuring preterm, growth, development, premature birth, infant, massage, weight gain

Eligibility Criteria

6 Hours - 24 Hours (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 6-24-hour-old preterm infants with 32-<37 gestational weeks
  • birth weight ranging from 1,500 to <2,500 g
  • appropriate for gestational age
  • a minimum Apgar score of seven at the fifth minute
  • no history of neonatal resuscitation
  • stable vital condition
  • no invasive therapy during hospitalisation

Exclusion Criteria:

  • intrauterine growth retardation
  • untreated clinical sepsis
  • congenital abnormalities such as congenital heart disease
  • history of hyperbilirubinemia

Sites / Locations

  • Dr. Cipto Mangunkusumo Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention Group

Control Group

Arm Description

Tactile-kinesthetic stimulation (TKS) was performed with a specific baby oil provided by the investigator. Tactile stimulation was performed while the neonate was in prone position. Light massage was applied in the head, shoulder, back, legs and arms of the infants. Every massage was performed for 2 × 5 seconds, with a total duration of 5 minutes. Kinesthetic stimulation, including elbow flexion-extension movement, palm massages, flexion-extension of the knees and legs and plantar massages, was applied while the neonate was in supine position. Each kinesthetic stimulation was performed for 2 × 5 seconds. Each movement was repeated six times, with a total duration of 5 minutes. Tactile stimulation was repeated once after kinesthetic stimulation. The total duration of TKS was 15 minutes which was performed three times daily preferably between breastfeeding or bottle feeding for 10 consecutive days.

Control group was not given TKS.

Outcomes

Primary Outcome Measures

Change from Birth Body Weight at 11 Days Old
Scale in grams. Using calibrated baby scale with accuracy of 10g, plotted in 2013 Fenton growth chart. The measurement was obtained twice if the same result was obtained and three times if the results differed. The mean was calculated.
Change from Birth Body Weight at 40 Weeks of Postmenstrual Age
Scale in grams. Using calibrated baby scale with accuracy of 10g, plotted in 2013 Fenton growth chart. The measurement was obtained twice if the same result was obtained and three times if the results differed. The mean was calculated.
Change from Birth Body Weight at 3 Months Old
Scale in grams. Using calibrated baby scale with accuracy of 10g, plotted in 2013 Fenton growth chart. The measurement was obtained twice if the same result was obtained and three times if the results differed. The mean was calculated.
Change from Birth Body Length at 11 Days Old
Scale in centimeters. Using a length board, plotted in 2013 Fenton growth chart.
Change from Birth Body Length at 40 Weeks of Postmenstrual Age
Scale in centimeters. Using a length board, plotted in 2013 Fenton growth chart.
Change from Birth Body Length at 3 Months Old
Scale in centimeters. Using a length board, plotted in 2013 Fenton growth chart.
Change from Birth Head Circumference at 11 Days Old
Scale in centimeters. Using a non-elastic tape, plotted in 2013 Fenton growth chart. Head circumference was measured three times from the glabella to the posterior occiput, and the largest measurement was recorded.
Change from Birth Head Circumference at 40 Weeks of Postmenstrual Age
Scale in centimeters. Using a non-elastic tape, plotted in 2013 Fenton growth chart. Head circumference was measured three times from the glabella to the posterior occiput, and the largest measurement was recorded.
Change from Birth Head Circumference at 3 Months Old
Scale in centimeters. Using a non-elastic tape, plotted in 2013 Fenton growth chart. Head circumference was measured three times from the glabella to the posterior occiput, and the largest measurement was recorded.
Change from 6-24 hours of Age Neurobehavior at 11-14 Days of Age
Using Dubowitz examination. The minimum Dubowitz score is 0 and the maximum is 72.
Change from 6-24 hours of age Neurobehavior at Term or 40 Weeks of Postmenstrual Age
Using Dubowitz examination. The minimum Dubowitz score is 0 and the maximum is 72.
Change from 6-24 hours of age Neurobehavior at 3 Months Old
Using Dubowitz examination. The minimum Dubowitz score is 0 and the maximum is 72.
Infant Development
Using Capute scales.

Secondary Outcome Measures

Full Information

First Posted
March 12, 2021
Last Updated
March 17, 2021
Sponsor
Indonesia University
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1. Study Identification

Unique Protocol Identification Number
NCT04807088
Brief Title
Effect of Tactile-Kinesthetic Stimulation on Preterm Neonates
Official Title
Effect of Tactile-Kinesthetic Stimulation on Growth, Neurobehavior and Development Among Preterm Neonates
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2015 (Actual)
Primary Completion Date
July 14, 2017 (Actual)
Study Completion Date
July 14, 2017 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
An interventional study to evaluate the effect of tactile-kinesthetic stimulation (TKS) on growth, neurobehavior and development among preterm neonates in the neonatal unit of Dr. Cipto Mangunkusumo Hospital.
Detailed Description
Preterm neonates were recruited via random sampling and divided into two groups (intervention group and control group). A written informed consent was obtained from the parents or guardians. Before the intervention, physical examination was performed to ensure the neonates had normal vital signs, were healthy and did not present with congenital abnormalities. In the intervention group, TKS was performed with specific baby oil for 15 minutes, three times a day, for 10 days. After 10 days, TKS was applied once daily by the mother or caregiver. TKS implementation at home was supervised by the investigator or nurse through phone call. The TKS were documented by the mother or caregiver in the diary card, which should be brought during the next visit when the neonate was 11-14 days old. In addition to TKS, history of illness and nutrition which was confirmed through history taking during hospital or home visit, was also recorded. The participants who did not go the hospital were home visited by the investigator or nurse. Anthropometric measurement by investigator and trained nurses and Dubowitz examination was performed by investigator in a warm and quiet place in the neonatal unit, mother-baby unit, outpatient clinic or participants' home while the neonate was fully alert. At 3 months of age, infant development was assessed by the investigator using the Capute scales (Developmental Quotient of Clinical Adaptive Test [DQ CAT], Clinical Linguistic Adaptive Milestone Scale [DQ CLAMS]) and the Full Scale Developmental Quotient (FS DQ) score. The Clinical Linguistic Adaptive Milestone Scale (CLAMS) score was based on the parent's report of language skill attainment. The Clinical Adaptive Test (CAT) score was based on the child's performance according to the listed items.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant, Premature, Diseases
Keywords
preterm, growth, development, premature birth, infant, massage, weight gain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Tactile-kinesthetic stimulation (TKS) was performed with a specific baby oil provided by the investigator. Tactile stimulation was performed while the neonate was in prone position. Light massage was applied in the head, shoulder, back, legs and arms of the infants. Every massage was performed for 2 × 5 seconds, with a total duration of 5 minutes. Kinesthetic stimulation, including elbow flexion-extension movement, palm massages, flexion-extension of the knees and legs and plantar massages, was applied while the neonate was in supine position. Each kinesthetic stimulation was performed for 2 × 5 seconds. Each movement was repeated six times, with a total duration of 5 minutes. Tactile stimulation was repeated once after kinesthetic stimulation. The total duration of TKS was 15 minutes which was performed three times daily preferably between breastfeeding or bottle feeding for 10 consecutive days.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Control group was not given TKS.
Intervention Type
Procedure
Intervention Name(s)
Tactile-kinesthetic Stimulation
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change from Birth Body Weight at 11 Days Old
Description
Scale in grams. Using calibrated baby scale with accuracy of 10g, plotted in 2013 Fenton growth chart. The measurement was obtained twice if the same result was obtained and three times if the results differed. The mean was calculated.
Time Frame
On the first day and 11 days old.
Title
Change from Birth Body Weight at 40 Weeks of Postmenstrual Age
Description
Scale in grams. Using calibrated baby scale with accuracy of 10g, plotted in 2013 Fenton growth chart. The measurement was obtained twice if the same result was obtained and three times if the results differed. The mean was calculated.
Time Frame
On the first day and 40 weeks of postmenstrual age.
Title
Change from Birth Body Weight at 3 Months Old
Description
Scale in grams. Using calibrated baby scale with accuracy of 10g, plotted in 2013 Fenton growth chart. The measurement was obtained twice if the same result was obtained and three times if the results differed. The mean was calculated.
Time Frame
On the first day and 3 months old.
Title
Change from Birth Body Length at 11 Days Old
Description
Scale in centimeters. Using a length board, plotted in 2013 Fenton growth chart.
Time Frame
On the first day and 11 days old.
Title
Change from Birth Body Length at 40 Weeks of Postmenstrual Age
Description
Scale in centimeters. Using a length board, plotted in 2013 Fenton growth chart.
Time Frame
On the first day and 40 weeks of postmenstrual age.
Title
Change from Birth Body Length at 3 Months Old
Description
Scale in centimeters. Using a length board, plotted in 2013 Fenton growth chart.
Time Frame
On the first day and 3 months old.
Title
Change from Birth Head Circumference at 11 Days Old
Description
Scale in centimeters. Using a non-elastic tape, plotted in 2013 Fenton growth chart. Head circumference was measured three times from the glabella to the posterior occiput, and the largest measurement was recorded.
Time Frame
On the first day and 11 days old.
Title
Change from Birth Head Circumference at 40 Weeks of Postmenstrual Age
Description
Scale in centimeters. Using a non-elastic tape, plotted in 2013 Fenton growth chart. Head circumference was measured three times from the glabella to the posterior occiput, and the largest measurement was recorded.
Time Frame
On the first day and 40 weeks of postmenstrual age.
Title
Change from Birth Head Circumference at 3 Months Old
Description
Scale in centimeters. Using a non-elastic tape, plotted in 2013 Fenton growth chart. Head circumference was measured three times from the glabella to the posterior occiput, and the largest measurement was recorded.
Time Frame
On the first day and 3 months old.
Title
Change from 6-24 hours of Age Neurobehavior at 11-14 Days of Age
Description
Using Dubowitz examination. The minimum Dubowitz score is 0 and the maximum is 72.
Time Frame
6-24 hours of age and 11-14 days of age.
Title
Change from 6-24 hours of age Neurobehavior at Term or 40 Weeks of Postmenstrual Age
Description
Using Dubowitz examination. The minimum Dubowitz score is 0 and the maximum is 72.
Time Frame
6-24 hours of age and term or 40 weeks of postmenstrual age.
Title
Change from 6-24 hours of age Neurobehavior at 3 Months Old
Description
Using Dubowitz examination. The minimum Dubowitz score is 0 and the maximum is 72.
Time Frame
6-24 hours of age and 3 Months Old.
Title
Infant Development
Description
Using Capute scales.
Time Frame
3 months of age.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Hours
Maximum Age & Unit of Time
24 Hours
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 6-24-hour-old preterm infants with 32-<37 gestational weeks birth weight ranging from 1,500 to <2,500 g appropriate for gestational age a minimum Apgar score of seven at the fifth minute no history of neonatal resuscitation stable vital condition no invasive therapy during hospitalisation Exclusion Criteria: intrauterine growth retardation untreated clinical sepsis congenital abnormalities such as congenital heart disease history of hyperbilirubinemia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hartono Gunardi, MD, PhD
Organizational Affiliation
Pediatric Consultant, Head of Growth and Development-Social Pediatrics Division
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Cipto Mangunkusumo Hospital
City
Jakarta Pusat
ZIP/Postal Code
10430
Country
Indonesia

12. IPD Sharing Statement

Plan to Share IPD
No
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Effect of Tactile-Kinesthetic Stimulation on Preterm Neonates

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