Effect of Tactile-Kinesthetic Stimulation on Preterm Neonates

NCT04807088 | Completed

• 1 other identifier: 681/UN2.F1/ETIK/2015
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Infant, Premature, Diseases

Keywords

preterm; growth; development; premature birth; infant; massage; weight gain

Outcome Measures

Primary Outcomes (13)

• 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.

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control Group

PLACEBO COMPARATOR

Control group was not given TKS.

Other: Placebo

Interventions

Tactile-kinesthetic Stimulation PROCEDURE

Intervention Group

Placebo OTHER

Control Group

Eligibility Criteria

• Age: 6 Hours - 24 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• intrauterine growth retardation
• untreated clinical sepsis
• congenital abnormalities such as congenital heart disease
• history of hyperbilirubinemia

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Dr. Cipto Mangunkusumo Hospital

Jakarta Pusat, 10430, Indonesia

Location

Related Publications (17)

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

  PMID: 23795251 BACKGROUND

• Alvarez MJ, Fernandez D, Gomez-Salgado J, Rodriguez-Gonzalez D, Roson M, Lapena 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.

  PMID: 28235686 BACKGROUND

• 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(Suppl 1):S2. doi: 10.1186/1742-4755-10-S1-S2. Epub 2013 Nov 15.

  PMID: 24625129 BACKGROUND

• 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.

  PMID: 24480603 BACKGROUND

• 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. doi: 10.1093/pch/17.10.561.

  PMID: 24294064 BACKGROUND

• 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. doi: 10.1002/mrdd.20048.

  PMID: 15856443 BACKGROUND

• 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.

  PMID: 32666281 BACKGROUND

• 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.

  PMID: 24639794 BACKGROUND

• 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.

  PMID: 21048258 BACKGROUND

• 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.

  PMID: 11677298 BACKGROUND

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

  PMID: 19030294 BACKGROUND

• 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.

  PMID: 19732117 BACKGROUND

• 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.

  PMID: 16208048 BACKGROUND

• 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.

  PMID: 19917121 BACKGROUND

• 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. doi: 10.1097/00005176-200010000-00011.

  PMID: 11045835 BACKGROUND

• 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;2004(2):CD000390. doi: 10.1002/14651858.CD000390.pub2.

  PMID: 15106151 BACKGROUND

• 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.

  PMID: 21321024 BACKGROUND

MeSH Terms

Conditions

Infant, Premature, Diseases; Premature Birth; Weight Gain

Condition Hierarchy (Ancestors)

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

Study Officials

• Hartono Gunardi, MD, PhD

  Pediatric Consultant, Head of Growth and Development-Social Pediatrics Division

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Pediatrician, Head of Growth and Development-Social Pediatrics Division

Study Record Dates

• First Submitted: March 12, 2021
• First Posted: March 19, 2021
• Study Start: August 1, 2015
• Primary Completion: July 14, 2017
• Study Completion: July 14, 2017
• Last Updated: March 19, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)