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Completed

NCT Number: NCT04807088

Effect of Tactile-Kinesthetic Stimulation on 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.

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Key information

Conditions

Infant, Premature, Diseases Body Weight Body Weight Changes Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Infant, Newborn, Diseases Obstetric Labor Complications Obstetric Labor, Premature Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Signs and Symptoms Urogenital Diseases Weight Gain

Age range

6 hour–24 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Cipto Mangunkusumo Hospital

Jakarta Pusat, 10430, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tactile-kinesthetic Stimulation

Procedure

Placebo

Other

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. Infant Development

    Time frame: 3 months of age.

    Using Capute scales.

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Mar 19, 2021
Registry last updated
Mar 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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