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Completed
NCT05683210
Comparison of The Effects of Initial Oral Feeding by Cup and Bottle-Feeding of Preterm Infants
Conditions: Oxygen Saturation, Heart Rate, Nutritional Status
Sex: All
Ages: 30 Weeks – 34 Weeks
Healthy volunteers: 1
Phase: NA
Enrollment: 80
Sponsor: Istanbul University - Cerrahpasa (IUC)
Location: Turkey
Summary
The research was planned in a randomized controlled experimental design to determine the effects of the cup and bottle used during the first oral feeding on physiological characteristics and feeding performance in preterm infants.
The research was carried out between January 2021 and February 2022 at the Neonatal Intensive Care Unit of Göztepe Süleyman Yalçın City Hospital.
Research data were obtained from preterm infants who were born before 34 weeks of gestation, appropriate to selection of study group criterias and hospitalized in the neonatal intensive care unit.
A total of 80 babies in the sample group were randomly assigned to the experimental (bottle) and control (cup) groups.
Oxygen saturation, heart rate, feeding performance and test weight before, during and after feeding of preterms in both groups were compared.
There was no statistically significantly difference between the experimental and control groups in terms of oxygen saturation and heart rate.
Eligibility Criteria
Criteria for Sample SelectionBeing at the ≤34th gestational week according to the last menstrual period of the mother of the pretermBeing at the ≥30th postmenstrual week on the date of inclusion in the studyHaving a body weight of 1000 grams or more on the date of inclusion in the studySwitching from enteral feeding to oral feeding for the first time with the joint decision of the physician and nurseBreastfeedingShowing physiological and behavioural signs indicating that the infant is ready for oral feeding (tolerating full enteral feeding, exhibiting sucking behaviour, opening the mouth by responding to stimuli around the mouth, normal physiological values [HR of 120-160/min, SpO2≥90], maintaining alertness, keeping the body in flexion posture)Having parental consent for inclusion in the study and an informed consent form signed by parentsExclusion CriteriaHaving diagnostic criteria for severe bronchopulmonary dysplasia (≥30% O2 requirement and/or positive pressure requirement at the 36th postmenstrual week or at discharge in preterm infants with a gestational age of <32 weeks; ≥30% O2 requirement or positive pressure requirement at the 56th postnatal day or at discharge in preterm infants with a gestational age of ≥32 weeks)Having an anomaly such as cleft palate, cleft lipHaving gastrointestinal, neurological or genetic disease (NEC, IVH, hydrocephalus, asphyxia, Down syndrome, short bowel syndrome, etc.)
Source: ClinicalTrials.gov (NCT05683210). StuddyBuddy aggregates publicly available trial information.