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Clinical Trials/NCT05486663
NCT05486663
Recruiting
N/A

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

Gonca Karatas Baran1 site in 1 country80 target enrollmentAugust 1, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Breast Feeding, Exclusive
Sponsor
Gonca Karatas Baran
Enrollment
80
Locations
1
Primary Endpoint
transition time (day) to full oral feeding
Status
Recruiting
Last Updated
last year

Overview

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2022
End Date
August 1, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Gonca Karatas Baran
Responsible Party
Sponsor Investigator
Principal Investigator

Gonca Karatas Baran

Dr Nurse

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

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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.

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.

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

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.

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.

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.

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.

length of hospital stay (days)

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

length of hospital stay (days)

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.

Study Sites (1)

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