Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06371443 |
| Other study ID # |
ayselkokcudogan |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 3, 2021 |
| Est. completion date |
August 1, 2022 |
Study information
| Verified date |
April 2024 |
| Source |
Istanbul Medipol University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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 (n=41) were given suck-swallow exercises for 12 minutes once a day before feeding for
14 days. SPSS21 was used to analyze the data.
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 G*Power 3.1 program. Infants
enrolled in the study were randomized in order of arrival to avoid bias. The randomization
table was generated by "https://www.calculatorsoup.com" 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 infant's 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 infant's 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) 22.0 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:
26.10.2021) 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.
