Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06371443
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2022-08-19
Brief Title:
Suction and Swalloing Exercises for Premature Babies
Sponsor:
Istanbul Medipol University Hospital
Organization:
Istanbul Medipol University Hospital
Study Overview
Official Title:
The Effects of Sucking and Swallowing Exercises on the Transition Process to Oral Feeding in Premature İnfants
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Underdeveloped oral structures of preterm infants cause feeding problems Therefore the development of sucking reflexes of premature babies should be supported
This study aimed to investigate the effect of suck-swallow training on the transition to oral feeding in premature infants
The study was conducted as a randomized controlled experimental trial in the NICU of a public hospital in Istanbul The study sample consisted of 82 premature infants Of these infants 41 were assigned to the experimental group and 41 to the control group Study data were collected using the investigator-developed Premature Infant Data Collection Form and Early Feeding Skills Assessment Tool Throughout the study preterm infants in the experimental group n41 were given suck-swallow exercises for 12 minutes once a day before feeding for 14 days SPSS21 was used to analyze the data
This study aimed to investigate the effect of suck-swallow training on the transition to oral feeding in premature infants
The study was conducted as a randomized controlled experimental trial in the NICU of a public hospital in Istanbul The study sample consisted of 82 premature infants Of these infants 41 were assigned to the experimental group and 41 to the control group Study data were collected using the investigator-developed Premature Infant Data Collection Form and Early Feeding Skills Assessment Tool Throughout the study preterm infants in the experimental group n41 were given suck-swallow exercises for 12 minutes once a day before feeding for 14 days SPSS21 was used to analyze the data
Detailed Description:
This study was conducted as a randomized controlled experimental study to evaluate the effect of sucking and swallowing training on the transition to oral feeding in premature infants The study sought to answer the question Do suckling and swallowing exercises have an effect on the transition to oral feeding The study was carried out between December 2021 and June 2022 at the neonatal intensive care unit of a public hospital in Istanbul The study sample consisted of infants who were admitted to the neonatal intensive care unit of a public hospital in Istanbul who met the inclusion criteria and whose parents consented to the study A power analysis was performed to determine the number of subjects to be included in the study The power of the test was calculated using the GPower 31 program Infants enrolled in the study were randomized in order of arrival to avoid bias The randomization table was generated by httpswwwcalculatorsoupcom as follows
Data were collected using the Premature Infant Data Collection Form and the Early Feeding Skills Assessment Tool
The premature infant data collection form developed by the investigators consists of 2 parts The first part contains descriptive information about the parents gender age education level number of children social security The second part contains descriptive details of the infant sex mode of delivery Apgar score week of birth postmenstrual week at enrollment birth weight weight at enrollment head circumference-height at birth phototherapy status within the last 24 hours oxygen support status
Application in the experimental group Informed consent was obtained from the parents of the infants in the experimental group who had low suckling success and met the inclusion criteria After completing the premature infant data collection form the investigator assessed the infants sucking activity Infants with no suck reflex were included in the study group The oral motor stimulation exercises developed by Fucile and applied to the infants in the experimental group who needed suckling and swallowing exercises were evaluated according to the Early Feeding Skills measurement tool The investigator performed the exercises on the infants once a day for 12 minutes before feeding for 14 days After 14 days the infants were assessed again using the EFS scale
Application in the control group First informed consent was obtained from the parents of the infants in the control group who met the inclusion criteria After completing the premature infant data collection form the infants sucking activity was assessed Infants who did not show a suck reflex were included in the study group and the infants were evaluated using the Early Feeding Skills EFS measurement tool at baseline and at 14 days
The data collected in the study were analyzed using SPSS Statistical Package for Social Sciences 220 for Windows software Numbers percentages means and standard deviations were used as descriptive statistical methods to analyze the data Kurtosis and skewness values were examined using chi-square and t-tests to determine whether the study variables were normally distributed
The study was conducted after obtaining the necessary permissions from XXXXXXXX Non-Interventional Clinical Research Ethics Committee decision number 1054 date 26102021 and the hospital where the study was to be conducted as well as the informed consent of the parents who consented their children to participate in the study Infants enrolled in the study were not exposed to practices or procedures that would violate patient rights that parents would consider inappropriate or that would adversely affect the patient
Data were collected using the Premature Infant Data Collection Form and the Early Feeding Skills Assessment Tool
The premature infant data collection form developed by the investigators consists of 2 parts The first part contains descriptive information about the parents gender age education level number of children social security The second part contains descriptive details of the infant sex mode of delivery Apgar score week of birth postmenstrual week at enrollment birth weight weight at enrollment head circumference-height at birth phototherapy status within the last 24 hours oxygen support status
Application in the experimental group Informed consent was obtained from the parents of the infants in the experimental group who had low suckling success and met the inclusion criteria After completing the premature infant data collection form the investigator assessed the infants sucking activity Infants with no suck reflex were included in the study group The oral motor stimulation exercises developed by Fucile and applied to the infants in the experimental group who needed suckling and swallowing exercises were evaluated according to the Early Feeding Skills measurement tool The investigator performed the exercises on the infants once a day for 12 minutes before feeding for 14 days After 14 days the infants were assessed again using the EFS scale
Application in the control group First informed consent was obtained from the parents of the infants in the control group who met the inclusion criteria After completing the premature infant data collection form the infants sucking activity was assessed Infants who did not show a suck reflex were included in the study group and the infants were evaluated using the Early Feeding Skills EFS measurement tool at baseline and at 14 days
The data collected in the study were analyzed using SPSS Statistical Package for Social Sciences 220 for Windows software Numbers percentages means and standard deviations were used as descriptive statistical methods to analyze the data Kurtosis and skewness values were examined using chi-square and t-tests to determine whether the study variables were normally distributed
The study was conducted after obtaining the necessary permissions from XXXXXXXX Non-Interventional Clinical Research Ethics Committee decision number 1054 date 26102021 and the hospital where the study was to be conducted as well as the informed consent of the parents who consented their children to participate in the study Infants enrolled in the study were not exposed to practices or procedures that would violate patient rights that parents would consider inappropriate or that would adversely affect the patient
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None