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

NCT05683210 | Completed

• 1 other identifier: cup and bottle feeding
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

preterm infants; oxygen saturation; heart rate

Outcome Measures

Primary Outcomes (1)

• Feeding Status

  In order to assess the feeding status of the infant, his/her time of feeding and the amount of nutrient he/she receives in a minute will be calculated. In order to determine his/her time of feeding, a phone chronometer will be started as soon as he/she begins feeding and it will be stopped when feeding is over. All infants in experimantal group and control group will be fed with a slow-flow bottle branded Avent which is designed for premature infants. It will be calculated how much (cc) of the total amount of nutrient ordered by the doctor the infant receives. The total amount of nutrient received by the infant will be divided into the time of feeding and thus the amount of nutrient received in a minute (cc) will be calculated.

  maximum 30 minutes

Secondary Outcomes (2)

• Heart Rate

  All babies in experimental group and control group will be recorded in the registration form by the observing nurse once half an hour before the feeding time, 30 minutes before the feeding time, during the feeding and at 30 minutes after the feeding.

• Oxygen Saturation

  All babies in experimental group and control group will be recorded in the registration form by the observing nurse once half an hour before the feeding time, 30 minutes before the feeding time, during the feeding and at 30 minutes after the feeding.

Study Arms (2)

Cup feeding

EXPERIMENTAL

The infants in the control group were fed with a cup. During feeding, all infants in this group were placed in semi-elevated supine position. The position of the infant was adjusted so that when the milk reached the tongue, the infant would start foraging, dip his/her tongue into the milk by dimpling and slurp the milk with his/her tongue through a negative pressure, swallow as much as he/she wants and leave the rest back to the cup. The stopwatch was activated when the infant began to drink the milk from the cup, and the stopwatch was stopped when the infant no longer slurped the milk, and the feeding process was completed. When the infant was physiologically (HR of 120-160/min, SpO2 ≥90) and behaviourally ready, feeding was resumed and the infant was prevented from getting tired during feeding and actively participated in feeding. Feeding time was limited to 30 minutes in either group, including the infants' resting time.

Behavioral: Cup feeding

Bottle feeding

EXPERIMENTAL

The infants in the experimental group were fed with a bottle. The teat of the feeding bottle was selected to be smaller in size, softer and with a smaller hole than the teat of the term infant and suitable for preterm infants. The same brand and model of bottle and teat were used for each infant. All infants in this group were fed in a semi-elevated side-lying position, as it was more similar to the position in which the infant suckled the mother's breast. The infant's lips were tapped with the bottle teat for stimulating to feed, and when the infant opened his/her mouth and drooped his/her tongue, the teat of the bottle was put into his/her mouth. The time elapsed from when the infant started to suck the bottle until he/she released the bottle from his/her mouth was considered as the feeding phase.

Behavioral: Bottle feeding

Interventions

Cup feeding BEHAVIORAL

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.

Cup feeding

Bottle feeding BEHAVIORAL

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.

Bottle feeding

Eligibility Criteria

• Age: 30 Weeks - 34 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may not qualify if:

• Having 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 lip
• Having gastrointestinal, neurological or genetic disease (NEC, IVH, hydrocephalus, asphyxia, Down syndrome, short bowel syndrome, etc.)

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University, Cerrahpaşa

Istanbul, Turkey (Türkiye)

Location

Study Officials

• Duygu Gözen

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse

Study Record Dates

• First Submitted: January 3, 2023
• First Posted: January 13, 2023
• Study Start: January 13, 2021
• Primary Completion: February 20, 2022
• Study Completion: February 20, 2022
• Last Updated: January 13, 2023

Record last verified: 2023-01

Locations

TU (1)