Effect of Tactile-Kinesthetic Stimulation on Growth, Neurobehavior and Development Among Preterm Neonates
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- Change from Birth Body Weight at 11 Days Old
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 6 Hours 至 24 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •intrauterine growth retardation
- •untreated clinical sepsis
- •congenital abnormalities such as congenital heart disease
- •history of hyperbilirubinemia
结局指标
主要结局
Change from Birth Body Weight at 11 Days Old
时间窗: 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 3 Months Old
时间窗: 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 40 Weeks of Postmenstrual Age
时间窗: 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 Head Circumference at 3 Months Old
时间窗: 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
时间窗: 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.
Infant Development
时间窗: 3 months of age.
Using Capute scales.
Change from Birth Head Circumference at 11 Days Old
时间窗: 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 Body Length at 11 Days Old
时间窗: 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 3 Months Old
时间窗: On the first day and 3 months old.
Scale in centimeters. Using a length board, plotted in 2013 Fenton growth chart.
Change from 6-24 hours of age Neurobehavior at Term or 40 Weeks of Postmenstrual Age
时间窗: 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
时间窗: 6-24 hours of age and 3 Months Old.
Using Dubowitz examination. The minimum Dubowitz score is 0 and the maximum is 72.
Change from Birth Body Weight at 40 Weeks of Postmenstrual Age
时间窗: 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 Head Circumference at 40 Weeks of Postmenstrual Age
时间窗: 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.
次要结局
未报告次要终点
研究者
Prof. Hartono Gunardi, MD, PhD
Consultant Pediatrician, Head of Growth and Development-Social Pediatrics Division
Indonesia University