Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06447558
Status:
COMPLETED
Last Update Posted:
2024-06-07
First Post:
2024-04-20
Brief Title:
The Effects of Oral Administration of Breast Milk Droplets and Palatal Stimulation With a Finger
Sponsor:
Istanbul Medipol University Hospital
Organization:
Istanbul Medipol University Hospital
Study Overview
Official Title:
The Effects of Oral Administration of Breast Milk Droplets and Palatal Stimulation With a Finger Methods on Feed Tolerance in Preterm Newborns Fed Via an Orogastric Tube
Status:
COMPLETED
Status Verified Date:
2024-06
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:
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 220 for Windows software was used for statistical analysis
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 220 for Windows software was used for statistical analysis
Detailed 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 tubeThe 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 httpswwwcalculatorsoup 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 ie 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 05 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 220 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 Fishers 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
Study Execution
Pre-Procedure The steps before the procedure were the same for each group ie 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 05 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 220 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 Fishers 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
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