Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT06447558 |
Other study ID # |
E-10840098-772.02-4979 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
May 1, 2021 |
Est. completion date |
June 28, 2022 |
Study information
Verified date |
June 2024 |
Source |
Istanbul Medipol University Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The aim of this study was to investigate the effects of "oral administration of breast milk
droplets" and "finger palatal stimulation" on feeding tolerance in preterm neonates fed with
orogastric tube feeding.
This randomized controlled experimental study was conducted in the neonatal intensive care
unit of a private hospital. The study included 90 premature newborns born at 28-36 weeks of
gestation and admitted to the intensive care unit. The intervention group consisted of 60
infants and the control group consisted of 30 infants. "Demographic Information Form" and
"Patient Follow-up Form" were used to collect data. Data collection tools were used before,
during and after the procedures in all groups. In one of the intervention groups, breast milk
droplets were applied to the oral cavity of the newborns, and in the other group, the palate
of the newborns was stimulated using a finger. These interventions were performed for 5
minutes every 3 hours for 7 days during the newborns' feeding times. Neonates in the control
group were fed with an orogastric tube by following hygiene rules, but no study intervention
was performed in these infants. SPSS (Statistical Package for Social Sciences) 22.0 for
Windows software was used for statistical analysis.
Description:
This is a randomized, controlled and experimental study investigating the effects of "oral
administration of breast milk droplets" and "finger palatal stimulation" methods on feeding
tolerance in infants fed with an orogastric tube.The study included 90 premature infants who
were 28-36 weeks of gestation, admitted to the neonatal intensive care unit and whose parents
consented to participate. Two intervention groups (Intervention1 and Intervention2) consisted
of a total of 60 infants and the control group consisted of 30 infants. A power analysis was
conducted to calculate the number of premature infants to be included in the study. We
created the randomization table using the instructions in the following link:
"https://www.calculatorsoup". The study was completed with 90 newborns who met the inclusion
criteria and whose parents consented to participate. Of these newborns, 60 were in the
intervention group and 30 were in the control group. Data were collected using the
"Demographic Information Form" and "Patient Follow-up Form" developed by the researcher in
line with the literature.
Study Execution
Pre-Procedure: The steps before the procedure were the same for each group, i.e. the oral
administration of breast milk droplets group, the palatal stimulation group and the control
group. Before the procedure, the subjects' identities were checked and the Demographic
Information Form (gender, gestational week, birth weight, head circumference and height) and
Patient Follow-up Form were completed. The newborns in all groups were placed on an
orogastric tube, positioned, and finally the infants' heads were gently lifted from the bed
at a 30-degree angle. After achieving the correct position, their remains were checked and
the results were noted. The stomachs of all premature infants included in the study were
checked every 3 hours before feeding for 7 days.
Sequence of Procedures: Infants in the oral administration of breast milk droplets group were
fed with an oroastric catheter after a total of 0.5 cc of breast milk was administered in
drops using an insulin syringe for 5 minutes. In the palatal stimulation group, the palate
and gums were stimulated with slow and peristalsis-like movements for 5 minutes with the
gloved pinky finger of one hand while the infants were fed with an orogastric catheter,
following the necessary hygiene rules. Premature infants in the control group were fed with
orogastric catheter by following all hygiene rules, but no intervention was performed.
Intervention groups received intervention for 5 minutes every 3 hours during feeding hours
for 7 days.
Post Procedure: After feeding, all infants received routine comfort care, including diaper
care, positioning, and environmental adjustments (adjusting sound and light levels, etc.).
After routine comfort care, defecation was examined in all subjects every day during the
7-day follow-up period and the results were recorded. At the end of each day, the abdominal
circumference and body weight of the newborns were measured and the measurements were noted
on the forms. SPSS (Statistical Package for Social Sciences) 22.0 for Windows software was
used for statistical analysis. Number, percentage, mean and standard deviation were used in
descriptive statistical methods. Differences between the rates of categorical variables in
independent groups were analyzed using the chi-square test and Fisher's exact test. One-way
Analysis of Variance was used to compare quantitative continuous data between groups.
Repeated Measures ANOVA Test was used for within-group comparisons.