Effect of Tactile-Kinesthetic Stimulation on Preterm Neonates

Infant, Premature, Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04807088
• Other study ID #: 681/UN2.F1/ETIK/2015
• Status: Completed
• Phase: N/A
• Start date: August 1, 2015
• Est. completion date: July 14, 2017

Study information

• Verified date: March 2021
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: July 14, 2017
• Est. primary completion date: July 14, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 24 Hours

Eligibility

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

Related Conditions & MeSH terms

• Infant, Premature, Diseases

Intervention

Procedure:
• Tactile-kinesthetic Stimulation

Other:
• Placebo

Locations

Country	Name	City	State
Indonesia	Dr. Cipto Mangunkusumo Hospital	Jakarta Pusat

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & Publications (17)

Akhavan Karbasi S, Golestan M, Fallah R, Golshan M, Dehghan Z. Effect of body massage on increase of low birth weight neonates growth parameters: A randomized clinical trial. Iran J Reprod Med. 2013 Jul;11(7):583-8. — View Citation

Aliabadi F, Askary RK. Effects of tactile-kinesthetic stimulation on low birth weight neonates. Iran J Pediatr. 2013 Jun;23(3):289-94. — View Citation

Álvarez MJ, Fernández D, Gómez-Salgado J, Rodríguez-González D, Rosón M, Lapeña S. The effects of massage therapy in hospitalized preterm neonates: A systematic review. Int J Nurs Stud. 2017 Apr;69:119-136. doi: 10.1016/j.ijnurstu.2017.02.009. Epub 2017 Feb 14. Review. — View Citation

Blencowe H, Cousens S, Chou D, Oestergaard M, Say L, Moller AB, Kinney M, Lawn J; Born Too Soon Preterm Birth Action Group. Born too soon: the global epidemiology of 15 million preterm births. Reprod Health. 2013;10 Suppl 1:S2. doi: 10.1186/1742-4755-10-S1-S2. Epub 2013 Nov 15. Review. — View Citation

Diego MA, Field T, Hernandez-Reif M. Preterm infant weight gain is increased by massage therapy and exercise via different underlying mechanisms. Early Hum Dev. 2014 Mar;90(3):137-40. doi: 10.1016/j.earlhumdev.2014.01.009. Epub 2014 Jan 27. — View Citation

Dosman CF, Andrews D, Goulden KJ. Evidence-based milestone ages as a framework for developmental surveillance. Paediatr Child Health. 2012 Dec;17(10):561-8. Review. — View Citation

Dubowitz L, Ricciw D, Mercuri E. The Dubowitz neurological examination of the full-term newborn. Ment Retard Dev Disabil Res Rev. 2005;11(1):52-60. — View Citation

Elmoneim MA, Mohamed HA, Awad A, El-Hawary A, Salem N, El Helaly R, Nasef N, Abdel-Hady H. Effect of tactile/kinesthetic massage therapy on growth and body composition of preterm infants. Eur J Pediatr. 2021 Jan;180(1):207-215. doi: 10.1007/s00431-020-03738-w. Epub 2020 Jul 14. — View Citation

Kulkarni A, Kaushik JS, Gupta P, Sharma H, Agrawal RK. Massage and touch therapy in neonates: the current evidence. Indian Pediatr. 2010 Sep;47(9):771-6. Review. — View Citation

Mathai S, Fernandez A, Mondkar J, Kanbur W. Effects of tactile-kinesthetic stimulation in preterms: a controlled trial. Indian Pediatr. 2001 Oct;38(10):1091-8. — View Citation

Moddemann D, Shea S. The developmental paediatrician and neonatal follow-up. Paediatr Child Health. 2006 May;11(5):295. — View Citation

Orton J, Spittle A, Doyle L, Anderson P, Boyd R. Do early intervention programmes improve cognitive and motor outcomes for preterm infants after discharge? A systematic review. Dev Med Child Neurol. 2009 Nov;51(11):851-9. doi: 10.1111/j.1469-8749.2009.03414.x. Epub 2009 Sep 1. Review. — View Citation

Sankaranarayanan K, Mondkar JA, Chauhan MM, Mascarenhas BM, Mainkar AR, Salvi RY. Oil massage in neonates: an open randomized controlled study of coconut versus mineral oil. Indian Pediatr. 2005 Sep;42(9):877-84. — View Citation

Santos IS, Matijasevich A, Domingues MR, Barros AJ, Victora CG, Barros FC. Late preterm birth is a risk factor for growth faltering in early childhood: a cohort study. BMC Pediatr. 2009 Nov 16;9:71. doi: 10.1186/1471-2431-9-71. — View Citation

Soriano CR, Martinez FE, Jorge SM. Cutaneous application of vegetable oil as a coadjutant in the nutritional management of preterm infants. J Pediatr Gastroenterol Nutr. 2000 Oct;31(4):387-90. — View Citation

Vickers A, Ohlsson A, Lacy JB, Horsley A. Massage for promoting growth and development of preterm and/or low birth-weight infants. Cochrane Database Syst Rev. 2004;(2):CD000390. Review. — View Citation

Woythaler MA, McCormick MC, Smith VC. Late preterm infants have worse 24-month neurodevelopmental outcomes than term infants. Pediatrics. 2011 Mar;127(3):e622-9. doi: 10.1542/peds.2009-3598. Epub 2011 Feb 14. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	Infant Development	Using Capute scales.	3 months of age.