Clinical trial NCT04807088: 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
Overall status: COMPLETED
Phase: NA
Conditions: Infant, Premature, Diseases
Keywords: preterm
growth
development
premature birth
infant
massage
weight gain
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2021-03-19
Enrollment: 126
Sex: ALL
Minimum age (years): 6
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change from Birth Body Weight at 11 Days Old
timeFrame: On the first day and 11 days old.
measure: Change from Birth Body Weight at 40 Weeks of Postmenstrual Age
timeFrame: On the first day and 40 weeks of postmenstrual age.
measure: Change from Birth Body Weight at 3 Months Old
timeFrame: On the first day and 3 months old.
measure: Change from Birth Body Length at 11 Days Old
timeFrame: On the first day and 11 days old.
measure: Change from Birth Body Length at 40 Weeks of Postmenstrual Age
timeFrame: On the first day and 40 weeks of postmenstrual age.
measure: Change from Birth Body Length at 3 Months Old
timeFrame: On the first day and 3 months old.
measure: Change from Birth Head Circumference at 11 Days Old
timeFrame: On the first day and 11 days old.
measure: Change from Birth Head Circumference at 40 Weeks of Postmenstrual Age
timeFrame: On the first day and 40 weeks of postmenstrual age.
measure: Change from Birth Head Circumference at 3 Months Old
timeFrame: On the first day and 3 months old.
measure: Change from 6-24 hours of Age Neurobehavior at 11-14 Days of Age
timeFrame: 6-24 hours of age and 11-14 days of age.
measure: Change from 6-24 hours of age Neurobehavior at Term or 40 Weeks of Postmenstrual Age
timeFrame: 6-24 hours of age and term or 40 weeks of postmenstrual age.
measure: Change from 6-24 hours of age Neurobehavior at 3 Months Old
timeFrame: 6-24 hours of age and 3 Months Old.
measure: Infant Development
timeFrame: 3 months of age.
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Dr. Cipto Mangunkusumo Hospital
Study officials:
affiliation: Pediatric Consultant, Head of Growth and Development-Social Pediatrics Division
name: Hartono Gunardi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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