Effect of Tactile-Kinesthetic Stimulation on Preterm Neonates

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Infant, Premature, Diseases

Intervention / Treatment
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* Procedure: Tactile-kinesthetic Stimulation
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Hours
Maximum Age: 24 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>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<br> <br> |
| Placebo Comparator: Control Group<br>Control group was not given TKS. | Other: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | On the first day and 11 days old. | 
| 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. | On the first day and 40 weeks of postmenstrual age. | 
| 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. | On the first day and 3 months old. | 
| Change from Birth Body Length at 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Using Capute scales. | 3 months of age. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preterm, growth, development, premature birth, infant, massage, weight gain