Tactile/kinesthetic Stimulus Program

NCT05486663 | Recruiting

• 1 other identifier: NEONATAL CARE
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The study will be carried out as a prospective randomized controlled clinical study to determine the effect of tactile/kinesthetic stimulus program on preterm infants on transition time to full sucking, sucking success and hospital stay.

Conditions

Breast Feeding, Exclusive; Enteral Feeding; Hospital Stay

Keywords

breasfeeding; enteral feeding; tactile/kinesthetic intervention

Outcome Measures

Primary Outcomes (9)

• transition time (day) to full oral feeding

  This is the data on which day full oral feeding is started after admission to the neonatal intensive care unit.

  within the first 30 days of birth

• transition time(day) to oral feeding trials

  This is the data on which day oral feeding trials were performed after admission to the neonatal intensive care unit. intensive care unit.

  within the first 30 days of birth

• transition time (day) to full enteral feeding

  This is the data on which day full enteral feeding is started after admission to the neonatal intensive care unit.

  within the first 30 days of birth

• transition time (day) to enteral feeding trials

  This is the data on which day full enteral feeding is started after admission to the neonatal intensive care unit.

  within the first 30 days of birth

• time (day) to first breastfeeding

  This is the data on which day breastfeeding feeding is started after admission to the neonatal intensive care unit.

  within the first 30 days of birth

• latch score (first day of breastfeeding)

  Using LATCH Scale. The minimum LATCH score is 0 and the maximum is 10.

  first breastfeeding process (20 minutes)

• latch score (fifth day of breastfeeding)

  Using LATCH Scale. The minimum LATCH score is 0 and the maximum is 10.

  fifth day breastfeeding process (20 minutes)

• length of hospital stay (days)

  length of hospital stay (days)

  the date of at discharge (up to 40 weeks)

• change in weight before and after feeding

  babies will be weighed before and after feeding on the first, fifth, ninth, thirteenth day and at discharge

  the date of at discharge (up to 40 weeks)

Study Arms (2)

Tactile/kinesthetic Group

EXPERIMENTAL

After the stability of the general health status of the babies is ensured and the oral feeding decision is made, tactile / kinesthetic application will be made for 14 days, 2 times a day, for 15 minutes just before feeding.

Other: Tactile/kinesthetic Group

Control Group

NO INTERVENTION

Tactile / kinesthetic applications will not be applied to the control group and these babies will be followed for 14 days and at discharge after the stability of the general health status of the babies is ensured and the oral feeding decision is made.

Interventions

Tactile/kinesthetic Group OTHER

Tactile/kinesthetic stimulation is performed in three stages. In the first stage; for tactile stimulation; The baby is placed in the prone (prone) position in the incubator. Light massage was applied in the head, shoulder, back, legs and arms of the infants. Each massage is applied 12 times for 1 minute. Massage was performed for 5 seconds. In the second stage 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 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 14 consecutive days.

Also known as: Case

Tactile/kinesthetic Group

Eligibility Criteria

• Age: 28 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Born between 28-32 weeks of gestation,
• Stable vital signs,
• st and 5th minute APGAR score between 6-10,
• Babies who have received mechanical ventilator or continuous positive air pressure (CPAP) or both support after 48 hours have passed after stabilization,
• Does not have an anomaly that will prevent feeding,
• Oral feeding decision has been made,
• Babies of mothers who are willing to breastfeed their babies,
• Babies of parents who volunteered to participate in the study will be taken.

You may not qualify if:

• IUGG,
• Infants with severe asphyxia,
• Babies born with low birth weight according to their gestational week,
• Having an anomaly that will prevent her from feeding,
• Babies with unstable vital signs,
• Babies with congenital anomalies or serious complications
• Infants with intraventricular bleeding.
• Dismissal Criteria
• Babies whose oral feeding process is interrupted for more than 1 day due to neonatal problems.

Sponsors & Collaborators

• Gonca Karatas Baran: lead

Study Sites (1)

Etlık Zubeyde Hanım Kadın Hastalıkları Eğitim Ve Araştırma Hastanesi

Ankara, Eyalet/Yerleşke, 06290, Turkey (Türkiye)

RECRUITING

Related Publications (10)

• Bond C. Positive Touch and massage in the neonatal unit: a British approach. Semin Neonatol. 2002 Dec;7(6):477-86. doi: 10.1053/siny.2002.0149.

  PMID: 12614600 BACKGROUND

• Burklow KA, McGrath AM, Kaul A. Management and prevention of feeding problems in young children with prematurity and very low birth weight. Inf Young Children. 2002; 14(4):19-30.

  BACKGROUND

• Clark GF, Avery-Smith W, Wolf LS, Anthony P, Holm SE, Hertfelder SD, Youngstrom MJ; Eating and Feeding Task Force; Commission on Practice. Specialized knowledge and skills in eating and feeding for occupational therapy practice. Am J Occup Ther. 2003 Nov-Dec;57(6):660-78. doi: 10.5014/ajot.57.6.660. No abstract available.

  PMID: 14661785 BACKGROUND

• Diego MA, Field T, Hernandez-Reif M. Vagal activity, gastric motility, and weight gain in massaged preterm neonates. J Pediatr. 2005 Jul;147(1):50-5. doi: 10.1016/j.jpeds.2005.02.023.

  PMID: 16027695 BACKGROUND

• Fucile S, Gisel E, Lau C. Oral stimulation accelerates the transition from tube to oral feeding in preterm infants. J Pediatr. 2002 Aug;141(2):230-6. doi: 10.1067/mpd.2002.125731.

  PMID: 12183719 BACKGROUND

• Fuccile S. Pre-feeding Sensorimotor Stimulation as an Early Intervention Strategy to Enhance Oral Feeding Skills in Preterm Infants. Health Sciences - Occupational Health and Therapy, doctoral thesis, McGill University, QC, Canada, 2008

  BACKGROUND

• Gewolb IH, Vice FL. Abnormalities in the coordination of respiration and swallow in preterm infants with bronchopulmonary dysplasia. Dev Med Child Neurol. 2006 Jul;48(7):595-9. doi: 10.1017/S0012162206001241.

  PMID: 16780630 BACKGROUND

• Jaywant SS, Kale JS.The effect of pre-feeding protocol with andwithout tactile and kinaesthetic stimulation onoral motor ability & physiological stability inpreterm infants. Int J Health Sci Res. 2021;11(1):38-4

  BACKGROUND

• Mathai S, Fernandez A, Mondkar J, Kanbur W. Effects of tactilekinesthetic stimulation in preterms: a controlled trial. Indian Pediatr. 2001; 38(10),:1091-1098. • McGrath JM, Braescu AV. State of the science: feeding readiness in the preterm infant. J Perinat Neonatal Nur. 2004;18(4):353-368

  BACKGROUND

• Bache M, Pizon E, Jacobs J, Vaillant M, Lecomte A. Effects of pre-feeding oral stimulation on oral feeding in preterm infants: a randomized clinical trial. Early Hum Dev. 2014 Mar;90(3):125-9. doi: 10.1016/j.earlhumdev.2013.12.011. Epub 2014 Jan 23.

  PMID: 24461572 BACKGROUND

MeSH Terms

Conditions

Breast Feeding

Interventions

Touch

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Sensation; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• GONCA K KARATAS BARAN

  Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital

  STUDY DIRECTOR

Central Study Contacts

GONCA K KARATAS BARAN, PHD

CONTACT

05426058161; goncabaran@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The volunteer (newborn's mother or father) will not know which group she/he will be in before joining the study. After accepting to the participate in the study, the volunteer will be informed abouth which group her/his newborn will be in.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr Nurse

Model Details: There will be two group. One is intervential group, other is control group

Study Record Dates

• First Submitted: July 29, 2022
• First Posted: August 3, 2022
• Study Start: August 1, 2022
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)