Ignite Creation Date:
2024-05-06 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06194513
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-08
First Post:
2023-12-20
Brief Title:
Oral Motor Intervention to Preterms by Their Mothers
Sponsor:
Marmara University
Organization:
Marmara University
Study Overview
Official Title:
Examining the Effect of Oral Motor Intervention Applied to Preterm Babies by Their Mothers at Different Frequencies on Oral Feeding Performance and Mother Baby Bonding
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
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:
Babies who have been discharged from the neonatal intensive care unit and have difficulty in oral feeding will be identified Oral Motor Intervention PIOMI will be taught to the mothers of these babies and asked to practice As a result of this application the change in oral feeding skills in babies and its effect on mother-infant bonding will be evaluated
Detailed Description:
The aim of this study is to observe the changes in babies oral feeding skills and mothers mother-baby attachment evaluation status as a result of oral motor intervention PIOMI applied to preterms with oral feeding difficulties
An estimated 20 million babies are born preterm before the 37th week of gestation each year in the world and this number is increasing and complications of prematurity are among the leading causes of death among children under 5 years of age Three-quarters of these deaths are preventable with current cost-effective interventions
Problems experienced after discharge include delayed feeding ability food rejection difficulty in transitioning to solid foods and slowdown in growth The reasons that lead to these difficulties are These are post-discharge health problems such as immaturity parenteral or tube feeding as opposed to oral motor experience and neurological or cognitive disorders All of these make it difficult for the child to develop nutritional skills and cause stress depression and self-confidence in the family
Premature Infant Oral Motor Intervention PIOMI is a five-minute eight-step oral motor intervention applied to preterm infants that aims to mimic the in utero oral experience that strengthens and improves feeding mechanisms PIOMI provides assisted movement to activate muscle contraction for suckling and oral feeding generating force to move against resistance increasing functional response to pressure It improves control of movements in accordance with a specific protocol that includes light contact with fingertips on the lips cheeks chin gums palate and tongue for the first three minutes and pacifierthumb sucking for the last two minutes It was developed by Lessen BS to provide oral motor stimulation in preterm babies and its reliability study was conducted The Turkish adaptation of the application was made by Selver Güler and Zerrin Çiğdem in 2021
This oral motor intervention will be taught to the mother by a physiotherapist trained in this field and it is planned that the mother will perform the application In this way premature babies with low immunity will not risk their health and will be given the opportunity to be treated more safely at home rather than in a hospital environment which will save time and money The effect of oral motor intervention frequency on oral motor skills will also be examined through applications at different frequencies
Before the applications and after all the applications are completed LATCH Breastfeeding Assessment Tool and POFRAS Oral Feeding Readiness Assessment Scale in Preterm Babies are filled in by the physiotherapist to evaluate the oral motor skills of the babies and ABBÖ Mother Baby Attachment Scale is filled in by the mother to observe the mother-baby attachment status
Preterm 37 weeks of gestation and babies with a corrected age of up to 3 months will be evaluated Medical records and demographic data of the babies whose verbal and written consent has been obtained from their parents will be collected and PIOMI will be applied to the babies in the intervention groups by their mothers at different frequencies twice a day for 1 week once a day for 2 weeks In addition to these two groups there will be a control group and the evaluation results of the 3 groups will be examined It is planned to apply different frequencies to the babies in Groups 1 and 2 and Group 3Control group will be given oral activation only with a pacifier for 14 days
The sample size of this study was calculated using the GPower 3192 program In the analysis there was a medium effect size f 025 Type I α 005 and 80 power which should be included in each group The number of participants was calculated as 42 people in total 14 people per group
With this thesis the investigators aim to shed light on future studies by contributing to the literature and to observe the positive effect of this situation on both the baby and the mother by initiating an oral motor intervention in which the mother can directly participate in the treatment
An estimated 20 million babies are born preterm before the 37th week of gestation each year in the world and this number is increasing and complications of prematurity are among the leading causes of death among children under 5 years of age Three-quarters of these deaths are preventable with current cost-effective interventions
Problems experienced after discharge include delayed feeding ability food rejection difficulty in transitioning to solid foods and slowdown in growth The reasons that lead to these difficulties are These are post-discharge health problems such as immaturity parenteral or tube feeding as opposed to oral motor experience and neurological or cognitive disorders All of these make it difficult for the child to develop nutritional skills and cause stress depression and self-confidence in the family
Premature Infant Oral Motor Intervention PIOMI is a five-minute eight-step oral motor intervention applied to preterm infants that aims to mimic the in utero oral experience that strengthens and improves feeding mechanisms PIOMI provides assisted movement to activate muscle contraction for suckling and oral feeding generating force to move against resistance increasing functional response to pressure It improves control of movements in accordance with a specific protocol that includes light contact with fingertips on the lips cheeks chin gums palate and tongue for the first three minutes and pacifierthumb sucking for the last two minutes It was developed by Lessen BS to provide oral motor stimulation in preterm babies and its reliability study was conducted The Turkish adaptation of the application was made by Selver Güler and Zerrin Çiğdem in 2021
This oral motor intervention will be taught to the mother by a physiotherapist trained in this field and it is planned that the mother will perform the application In this way premature babies with low immunity will not risk their health and will be given the opportunity to be treated more safely at home rather than in a hospital environment which will save time and money The effect of oral motor intervention frequency on oral motor skills will also be examined through applications at different frequencies
Before the applications and after all the applications are completed LATCH Breastfeeding Assessment Tool and POFRAS Oral Feeding Readiness Assessment Scale in Preterm Babies are filled in by the physiotherapist to evaluate the oral motor skills of the babies and ABBÖ Mother Baby Attachment Scale is filled in by the mother to observe the mother-baby attachment status
Preterm 37 weeks of gestation and babies with a corrected age of up to 3 months will be evaluated Medical records and demographic data of the babies whose verbal and written consent has been obtained from their parents will be collected and PIOMI will be applied to the babies in the intervention groups by their mothers at different frequencies twice a day for 1 week once a day for 2 weeks In addition to these two groups there will be a control group and the evaluation results of the 3 groups will be examined It is planned to apply different frequencies to the babies in Groups 1 and 2 and Group 3Control group will be given oral activation only with a pacifier for 14 days
The sample size of this study was calculated using the GPower 3192 program In the analysis there was a medium effect size f 025 Type I α 005 and 80 power which should be included in each group The number of participants was calculated as 42 people in total 14 people per group
With this thesis the investigators aim to shed light on future studies by contributing to the literature and to observe the positive effect of this situation on both the baby and the mother by initiating an oral motor intervention in which the mother can directly participate in the treatment
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