Effect of Tactile-Kinesthetic Stimulation on Preterm Neonates

March 17, 2021 updated by: Prof. Hartono Gunardi, MD, PhD, Indonesia University

Effect of Tactile-Kinesthetic Stimulation on Growth, Neurobehavior and Development Among Preterm Neonates

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

126

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
      • Jakarta Pusat, Indonesia, 10430
        • Dr. Cipto Mangunkusumo Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 hours to 1 day (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention Group
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.
Procedure: Tactile-kinesthetic Stimulation
PLACEBO_COMPARATOR: Control Group
Control group was not given TKS.
Other: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Birth Body Weight at 11 Days Old
Time Frame: On the first day and 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.
On the first day and 11 days old.
Change from Birth Body Weight at 40 Weeks of Postmenstrual Age
Time Frame: On the first day and 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.
On the first day and 40 weeks of postmenstrual age.
Change from Birth Body Weight at 3 Months Old
Time Frame: On the first day and 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.
On the first day and 3 months old.
Change from Birth Body Length at 11 Days Old
Time Frame: On the first day and 11 days old.
Scale in centimeters. Using a length board, plotted in 2013 Fenton growth chart.
On the first day and 11 days old.
Change from Birth Body Length at 40 Weeks of Postmenstrual Age
Time Frame: On the first day and 40 weeks of postmenstrual age.
Scale in centimeters. Using a length board, plotted in 2013 Fenton growth chart.
On the first day and 40 weeks of postmenstrual age.
Change from Birth Body Length at 3 Months Old
Time Frame: On the first day and 3 months old.
Scale in centimeters. Using a length board, plotted in 2013 Fenton growth chart.
On the first day and 3 months old.
Change from Birth Head Circumference at 11 Days Old
Time Frame: On the first day and 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.
On the first day and 11 days old.
Change from Birth Head Circumference at 40 Weeks of Postmenstrual Age
Time Frame: On the first day and 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.
On the first day and 40 weeks of postmenstrual age.
Change from Birth Head Circumference at 3 Months Old
Time Frame: On the first day and 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.
On the first day and 3 months old.
Change from 6-24 hours of Age Neurobehavior at 11-14 Days of Age
Time Frame: 6-24 hours of age and 11-14 days of age.
Using Dubowitz examination. The minimum Dubowitz score is 0 and the maximum is 72.
6-24 hours of age and 11-14 days of age.
Change from 6-24 hours of age Neurobehavior at Term or 40 Weeks of Postmenstrual Age
Time Frame: 6-24 hours of age and term or 40 weeks of postmenstrual age.
Using Dubowitz examination. The minimum Dubowitz score is 0 and the maximum is 72.
6-24 hours of age and term or 40 weeks of postmenstrual age.
Change from 6-24 hours of age Neurobehavior at 3 Months Old
Time Frame: 6-24 hours of age and 3 Months Old.
Using Dubowitz examination. The minimum Dubowitz score is 0 and the maximum is 72.
6-24 hours of age and 3 Months Old.
Infant Development
Time Frame: 3 months of age.
Using Capute scales.
3 months of age.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Investigators

  • Principal Investigator: Hartono Gunardi, MD, PhD, Pediatric Consultant, Head of Growth and Development-Social Pediatrics Division

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2015

Primary Completion (ACTUAL)

July 14, 2017

Study Completion (ACTUAL)

July 14, 2017

Study Registration Dates

First Submitted

March 12, 2021

First Submitted That Met QC Criteria

March 17, 2021

First Posted (ACTUAL)

March 19, 2021

Study Record Updates

Last Update Posted (ACTUAL)

March 19, 2021

Last Update Submitted That Met QC Criteria

March 17, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 681/UN2.F1/ETIK/2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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