Nutrition Clinical Trial
Official title:
The Effect of Supplemental Feeding System on Preterm Infants' Oral Feeding Skils: Randomized Controlled Trial
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 2023 |
Est. primary completion date | August 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 34 Weeks to 36 Weeks |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - Having diseases other than being preterm, - Capable of successfully taking the breast at the first attempt (Early Feeding Skill/EFS: 57), - With congenital anomaly, - With chromosomal disorders, - With sepsis, - With intracranial bleeding, - Those with a very low birth weight below 1500 g and - Preterm babies younger than 34 weeks of gestation will be excluded. |
Country | Name | City | State |
---|---|---|---|
Turkey | Harran University | Sanliurfa |
Lead Sponsor | Collaborator |
---|---|
Harran University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Early Feeding Skills | Before, during and after three feedings between 08:00 and 16:00 | through study completion, an average of 10 days | |
Secondary | Physiological parameters 1 (peak heart rate/minute) | Before, during and after three feedings between 08:00 and 16:00 | through study completion, an average of 10 days | |
Secondary | Physiological parameters 2 (oxygen saturation/ %) | Before, during and after three feedings between 08:00 and 16:00 | through study completion, an average of 10 days | |
Secondary | Physiological parameters 3 (respiratory rate/minute) | Before, during and after three feedings between 08:00 and 16:00 | through study completion, an average of 10 days |
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