Effect of Tactile-Kinesthetic Stimulation on Preterm Neonates

Sponsor

Indonesia University (Other)

Overall Status

Completed

CT.gov ID

NCT04807088

Collaborator

(none)

126

Enrollment

Location

Arms

23.4

Actual Duration (Months)

5.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Infant, Premature, Diseases	Procedure: Tactile-kinesthetic Stimulation Other: Placebo	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

126 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Aug 1, 2015

Actual Primary Completion Date :

Jul 14, 2017

Actual Study Completion Date :

Jul 14, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change from Birth Body Weight at 11 Days Old [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.
Change from Birth Body Weight at 40 Weeks of Postmenstrual Age [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.
Change from Birth Body Weight at 3 Months Old [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.
Change from Birth Body Length at 11 Days Old [On the first day and 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 [On the first day and 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 [On the first day and 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 [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.
Change from Birth Head Circumference at 40 Weeks of Postmenstrual Age [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.
Change from Birth Head Circumference at 3 Months Old [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.
Change from 6-24 hours of Age Neurobehavior at 11-14 Days of Age [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.
Change from 6-24 hours of age Neurobehavior at Term or 40 Weeks of Postmenstrual Age [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.
Change from 6-24 hours of age Neurobehavior at 3 Months Old [6-24 hours of age and 3 Months Old.]
Using Dubowitz examination. The minimum Dubowitz score is 0 and the maximum is 72.
Infant Development [3 months of age.]
Using Capute scales.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Hours to 24 Hours

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dr. Cipto Mangunkusumo Hospital	Jakarta Pusat		Indonesia	10430

Sponsors and Collaborators

Indonesia University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Prof. Hartono Gunardi, MD, PhD, Consultant Pediatrician, Head of Growth and Development-Social Pediatrics Division, Indonesia University

ClinicalTrials.gov Identifier:

NCT04807088

Other Study ID Numbers:

681/UN2.F1/ETIK/2015

First Posted:

Mar 19, 2021

Last Update Posted:

Mar 19, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Prof. Hartono Gunardi, MD, PhD, Consultant Pediatrician, Head of Growth and Development-Social Pediatrics Division, Indonesia University

Additional relevant MeSH terms:

Infant, Premature, Diseases

Study Results

No Results Posted as of Mar 19, 2021