Oral Motor Intervention to Preterms by Their Mothers
- Conditions
- Premature
- Registration Number
- NCT06194513
- Lead Sponsor
- Marmara University
- 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 pacifier/thumb 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 3/Control group will be given oral activation only with a pacifier for 14 days.
The sample size of this study was calculated using the G\*Power 3.1.9.2 program. In the analysis, there was a medium effect size (f = 0.25), Type I α = 0.05 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 42
- Participation in the study is accepted by the family
- PIOMI can be applied and whose clinical condition is stable,
- Born earlier than 37 weeks,
- Those who have not been diagnosed with any disorder in swallowing functions,
- Without congenital anomalies and systemic diseases,
- Vital signs are stable,
- Babies without congenital anomalies or serious complications
- Participation in the study is not accepted by their family,
- Those with congenital anomalies and systemic diseases.
- Those who have been diagnosed with swallowing disorder,
- Those with congenital disorders or birth trauma,
- Diagnosed with severe asphyxia,
- Those with intraventricular bleeding,
- Those with Neonatal Abstinence Syndrome,
- Those with Fetal Alcohol Syndrome,
- Babies connected to a ventilator
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The LATCH Breastfeeding Assessment Tool (Latch Audible Swallowing, Type of Nipple, Comfort of Breast/Nipple, H-Hold/ Position) 0, 7. day, 14. day LATCH is a tool created by analogy with the Apgar score system in terms of scoring method, and its evaluation is quick and easy.
The Turkish validity of the Assessment Tool was conducted by Demirhan in 1997, Koyun in 2001, and Yenal and Okumuş in 2003, and it was recommended to be used as a reliable tool. The highest score that can be obtained from the scale is 10 and the lowest score is 0. Increasing scores from the scale indicate breastfeeding success. Cronbach Alpha value of the LATCH Breastfeeding Assessment Tool; Yenal and Okumuş found it as 0.95, Demirhan as 0.94, and Koyun as 0.96.
The scale considers mother and baby together. It can be evaluated by a healthcare professional or the mother. In the evaluation; It includes the criteria for breast retention, the baby's swallowing movement, the type of nipple, the mother's comfort with the breast and nipple, and the position of holding the baby.Preterm Infant Oral Feeding Readiness Assessment (PIOFRA/ POFRAS) 0, 7. day, 14. day This scale consists of 5 categories (corrected gestational age, behavioral organization, mouth posture, oral reflexes, non-nutritive sucking) and 18 items and evaluates readiness for oral feeding in preterm infants. The scale is scored between 0-2 and the maximum score is 36. The cut-off point for switching a preterm baby to oral feeding was determined as 30 .
Turkish Validity-Reliability: In the Turkish adaptation of this scale made by Çamur and Çetinkaya in 2020, the cut-off point was found to be 29.
- Secondary Outcome Measures
Name Time Method The Mother to Infant Bonding Scale (MIBS) 0, 7. day, 14. day The scale is designed to be applied from the first day after birth and allows the mother to express her feelings towards her baby with a single word. This scale, which can be easily and quickly applied by the mother and father alone, shows the relationship between the bond established and the mother's early mood.
MIBS is a 4-point Likert scale consisting of 8 items. Responses consisting of four options are scored between 0-3, the lowest score that can be obtained from the scale is 0 and the highest score is 24. In the evaluation, the 1st, 4th, and 6th items express positive emotions and are scored as 0, 1, 2, 3, while the 2nd, 3rd, 5th, 7th items are scored as 0, 1, 2, 3. Items 1 and 8 are expressions of negative emotions and are scored in reverse, as 3, 2, 1, 0.
Trial Locations
- Locations (1)
Marmara University
🇹🇷Istanbul, Maltepe, Turkey