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NCT Number: NCT05486663

Tactile/kinesthetic Stimulus Program

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.

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Key information

Conditions

Breast Feeding, Exclusive Behavior Breast Feeding Enteral Feeding Feeding Behavior Hospital Stay

Age range

28 week–32 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Etlık Zubeyde Hanım Kadın Hastalıkları Eğitim Ve Araştırma Hastanesi

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

Location status: Recruiting

Location contact

GONCA KARATAS BARAN, PHD

CONTACT

[email protected]

05426058161

About this study

Application of the Research Tactile/kinesthetic Group After the stability in the general health status of the babies and the oral feeding decision are made, for 14 days, 2 times a day, just before feeding; There will be a 15-minute tactile/kinesthetic application. Complications that may develop during the tactile/kinesthetic application in infants will be monitored by evaluating the physical findings of the preterm infant and on the bedside monitor. In cases such as decreased oxygen saturation, apnea and bradycardia during the tactile/kinesthetic intervention, the procedure will not be performed or will be delayed until the baby regains stability.

Note: The application will be carried out by showing the necessary sensitivity for the preterm baby (not shaking the baby, not moving the baby suddenly, the temperature of the hands being close to the baby's body temperature, etc.) and by the researcher nurses experienced in NICU.

Control Group Tactile/kinesthetic applications will not be applied to the control group and these babies will be followed up 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.

In both groups; Baby scales and tape measure will be used for anthropometric measurement of body weight before and after breastfeeding. Other data will be obtained from the patient file and observations made during the hospitalization of the preterm infant.

The LATCH Breastfeeding Diagnosis Form (during the first mother's breastfeeding) will be filled in by observation, by the researcher and an observer nurse, as it is an observation-based form. The researcher will train the observer on the use of the LATCH Breastfeeding Diagnostic Form. The researcher and observer will simultaneously and independently evaluate each preterm infant by scoring the LATCH Breastfeeding Diagnostic Form during the breastfeeding period. In order to evaluate the agreement among the observers, the agreement will be evaluated by looking at Cohen's Kappa coefficient. The LATCH second measurement will be made on Day 5.

The amount of food taken during breastfeeding within 14 days (1st, 5th, 9th, 13th, and on the day of discharge) will be determined by measuring body weight before and after feeding. Body weight will be weighed before and after feeding at discharge. The times of full enteral feeding and full oral feeding will be recorded in the groups.

Hypotheses H0 hypothesis: Tactile/kinesthetic stimulus interventions have no effect on transition time to full oral feeding in preterm infants.

Hypothesis H1: In preterm infants, interventions with tactile/kinesthetic stimuli have an effect on transition time to full oral feeding.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Born between 28-32 weeks of gestation,
  • Stable vital signs,
  • 1st 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Other names: Case

Primary outcomes

  1. transition time (day) to full oral feeding

    Time frame: within the first 30 days of birth

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

  2. transition time(day) to oral feeding trials

    Time frame: within the first 30 days of birth

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

  3. transition time (day) to full enteral feeding

    Time frame: within the first 30 days of birth

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

  4. transition time (day) to enteral feeding trials

    Time frame: within the first 30 days of birth

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

  5. time (day) to first breastfeeding

    Time frame: within the first 30 days of birth

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

  6. latch score (first day of breastfeeding)

    Time frame: first breastfeeding process (20 minutes)

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

  7. latch score (fifth day of breastfeeding)

    Time frame: fifth day breastfeeding process (20 minutes)

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

  8. length of hospital stay (days)

    Time frame: the date of at discharge (up to 40 weeks)

    length of hospital stay (days)

  9. change in weight before and after feeding

    Time frame: the date of at discharge (up to 40 weeks)

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

Study contacts

Contact information is provided by the study sponsor or research team.

GONCA K KARATAS BARAN, PHD

CONTACT

[email protected]

05426058161

Sponsors and collaborators

Lead sponsor

Gonca Karatas Baran

Other

Registry information

Official study title

The Effect of the Tactile/kinesthetic Stimulus Program on the Maturation of Sucking Ability in Preterm Infants

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Aug 3, 2022
Registry last updated
Nov 22, 2024

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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