Comparison of The Effects of Initial Oral Feeding by Cup and Bottle-Feeding of Preterm Infants

NCT05683210 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-01-13

No results posted yet for this study

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.

Conditions

  • Oxygen Saturation
  • Heart Rate
  • Nutritional Status

Interventions

BEHAVIORAL

Cup feeding

The preterm infant was put on pulse oximetry and monitored, and heart rate and oxygen saturation began to be monitored. The infants' heart rate and oxygen saturation were recorded 30 minutes before feeding, and their signs of preparedness for oral feeding were monitored. After the data were recorded for 30 minutes, the infant was taken out of the incubator and his/her body weight was measured naked with only a clean diaper to determine the test weight. Feeding time was limited to 30 minutes, including the infants' resting time. When the infant was no longer sucking, the stopwatch was stopped, and the feeding phase was terminated. The feeding process was completed at the end of 30 minutes even if the infant did not take all of the food. The infant was followed up for 30 minutes after the end of feeding. During this time, the pulse oximetry continued to record and no intervention was made in order to avoid any effect on physiological values.

BEHAVIORAL

Bottle feeding

The preterm infant was put on pulse oximetry and monitored, and heart rate and oxygen saturation began to be monitored. The infants' heart rate and oxygen saturation were recorded 30 minutes before feeding, and their signs of preparedness for oral feeding were monitored. After the data were recorded for 30 minutes, the infant was taken out of the incubator and his/her body weight was measured naked with only a clean diaper to determine the test weight. During the feeding period, heart rate and oxygen saturation were continuously recorded. Feeding time was limited to 30 minutes, including the infants' resting time. When the infant was no longer sucking, the stopwatch was stopped, and the feeding phase was terminated. The infant was followed up for 30 minutes after the end of the feeding. During this time, the pulse oximetry continued to record and no intervention was made in order to avoid any effect on physiological values.

Sponsors & Collaborators

  • Istanbul University - Cerrahpasa

    lead OTHER

Principal Investigators

  • Duygu Gözen · Istanbul University - Cerrahpasa

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Weeks
Max Age
34 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-13
Primary Completion
2022-02-20
Completion
2022-02-20

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05683210 on ClinicalTrials.gov