The Effect of Supplemental Feeding System on Preterm Infants' Oral Feeding Skils: Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This research 34.-36. is carried out as a randomized controlled experimental design in order to evaluate the effectiveness of the supplemental feeding system to improve the early feeding skills of preterm infants receiving care in the neonatal intensive care unit at the gestational week.The universe of this research will consist of preterm infants hospitalized in the neonatal intensive care of Sanlıurfa Training and Research Hospital between July 2022 and April 2023. The sample size in the study was H00: There is no difference between preterm infants with supplemental feeding system and preterm infants fed with bottle in terms of early feeding skills. According to the hypothesis G\*Power Version 3.1.9.2 (Franz Foul, Universitat Kiel, Germany) was calculated in the program. In order to determine the difference between the groups, the number of groups is 2; number of repeated measurements 3; correlation between repeated measurements 0.5; Cohen\* effect size 0.25; The statistical power was determined as a sample size of 44 preterm infants, 22 of whom were fed with supplemental feeding system and 22 of whom were fed with bottle, with 95% and type 1 error of 5%. and infants assigned to groups by randomization method. Randomization in the study determined by entering the total number of cases through the program http://www.randomizer.org. Through this program, the infants forming the sample group randomly distributed to two groups and randomization made.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 7 months
Maximum Age: 8 months
Healthy Volunteers: f
View:

• Postmenstrual age between 34-36 weeks (preterm babies at 34 and 36 weeks of gestation will be included),

• Over 1500 g,

• Switching to oral feeding after feeding with orogastric tube,

• Breastfed during gavage feeding,

• Those who have not completed the first 24 hours in the transition from orgastric tube feeding to the oral feeding process,

• Having cues of readiness for feeding (tolerating enteral nutrition, having a stable oxygen saturation and respiration during feeding, having the ability to lick, swallow and suck, react when mouth and lip are given stimuli),

• The mother's willingness to breastfeed her baby,

• Preterm infants of parents who volunteered to participate in the study will be included.

Locations
Other Locations
Turkey
Harran University
RECRUITING
Sanliurfa
Contact Information
Primary
Fatma BOZDAĞ, Lecturer
fatmabozdag@harran.edu.tr
+90 541 775 27 08
Backup
Duygu GÖZEN, Professor
duygu.gozen@iuc.edu.tr
+90 532 706 50 65
Time Frame
Start Date: 2022-07-20
Estimated Completion Date: 2023-12
Participants
Target number of participants: 60
Treatments
Experimental: Supplemental Feeding System Group
3 feeding between 08-16:00 are carried out with the supplemental feeding system. The remaining 5 feedings continue with the bottle.
No_intervention: Bottle Feeding Group (Control)
All feedings are made from a bottle.
Related Therapeutic Areas
Sponsors
Leads: Harran University

This content was sourced from clinicaltrials.gov