Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05683210 |
| Other study ID # |
cup and bottle feeding |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 13, 2021 |
| Est. completion date |
February 20, 2022 |
Study information
| Verified date |
January 2023 |
| Source |
Istanbul University - Cerrahpasa (IUC) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
The coordination of sucking, swallowing and breathing is necessary for the preterm infant to
be effectively and safely fed by the oral route. Although the sucking motion begins in the
27-28th week, the coordination of sucking, swallowing, and breathing appears in the 32-34th
week. Introducing oral feeding to preterm infants is recommended by sucking the mother's
breast when they are ready for oral feeding. Preterm infants are fed through complementary
feeding methods such as a bottle, spoon, dropper, cup, and finger feeding until they reach
the condition to meet their nutritional needs by sucking the mother's breast.
Bottle feeding is one of the nutritive sucking methods commonly used in both preterm and term
infants worldwide. When the mother is unable to breastfeed or breast milk is not available,
preterm infants can be fed with a bottle. Bottle feeding contributes to effective feeding and
helps the infant to relax by meeting the sucking reflex. Cup feeding has been used in
developed and developing countries for many years to feed premature infants and those with
low birth weights. Cup feeding is a simple, practical, effective, and low cost method that
can be used in infants who can swallow but are unable to suck well enough to be fed
completely from the mother's breast, and in cases where an alternative such as a gastric
catheter or a bottle is required for feeding.
Studies that compared bottle and cup feeding reported that the swallowing performance of
preterm infants fed with a bottle was better, the length of hospital stay was longer in
preterm infants fed with a cup, and the duration of feeding was longer in preterms fed with a
cup compared to those fed with a bottle, the rate of breastfeeding after discharge was higher
in those fed with a cup, no significant difference was found in weight gain, but the quantity
of food intake was less and the rate of food spillage was higher in preterm infants fed with
a cup compared to those fed with a bottle. For all of these reasons, bottle feeding is
reported to be a safer and more appropriate method.
This randomised controlled experimental study was carried out to compare the effect of cup
and bottle feeding on physiological characteristics and feeding performance in preterm
infants born at or below the 34th gestational week. A power analysis was used to determine.
The study included a total of 80 preterms, 40 preterms for each group. The parents of preterm
infants who met the inclusion criteria granted their written and verbal consent.
Experimental Group
The preterm infant was put on pulse oximetry and monitored, and heart rate and oxygen
saturation began to be monitored. No invasive intervention or care was provided for the
infant to rest for 1 hour before feeding. Data were collected during working hours
(08.00-16.00) to establish common physical environment conditions for each infant. Bottles
and teats to be used during feeding were sterilised with a steam steriliser. The heart rate
and oxygen saturation of the infants were recorded 30 minutes before the time of 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. All findings were recorded on
the "Feeding Monitoring Form".
After all steps before feeding were completed and recorded, the infant was loosely wrapped
with a soft cloth and started to be fed by being held only by the researcher in order to
prevent the effect of different feeding practices of the nurses on the study. As soon as
feeding was initiated, a stopwatch was activated by another nurse who worked in the clinic in
order to avoid any bias, and the feeding time was maintained not to exceed 30 minutes to
prevent the infant from getting tired. During the feeding period, heart rate and oxygen
saturation were continuously recorded. 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 its 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. During feeding, stimulant
behaviours such as pushing the bottle back and forth and swirling the bottle in the mouth
were avoided in order to allow the infant to suck faster and accelerate the flow. 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.
Physiological and behavioural signs of stress (throwing the head backwards, trying to push
the bottle and cup away with the tongue, arching back, grimacing, fanning the fingers, rapid
and loud breathing, aspiration, coughing and trying to swallow quickly, desaturation (<90),
apnoea, tachycardia, bradycardia and colour change) were observed in all bottle and cup-fed
infants during feeding. Also, signs of fatigue (i.e., decreased muscle tone, inability to
maintain flexion posture, reduced sucking-swallowing activity, spilling milk out of the
mouth) were observed in both groups.
In case of signs of stress and fatigue, feeding was interrupted for a short time and the
infant was allowed to rest. 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,
including the infants' resting times. When the infant was no longer sucking, another nurse
who worked in the clinic stopped the stopwatch in order to prevent bias 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.
After feeding, the body weight of the infants was measured only with the diaper on and the
test weight was determined. Test weighing is a technique used to measure the amount of
nutrition of the infant, in which the infant is weighed before and after feeding without
undressing if the infant is dressed and without changing the diaper if the infant is
diapered, and 1 gram corresponds to 1 ml of breast milk. After the procedure, the infant was
put in the incubator in a right-side position to facilitate gastric discharge. 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. The recorded data were classified into pre-feeding, feeding and
post-feeding periods, entered into a computer environment, and averaged. The amount of food
taken by the infant during the 30-minute feeding was recorded, and if the infant was unable
to take the entire amount of food prescribed by the physician, he/she took the remaining
amount with an orogastric catheter after the post-feeding measurements were finished.
Control Group
The preterm infant was put on pulse oximetry and monitored, and heart rate and oxygen
saturation began to be monitored. No invasive intervention or care was provided for the
infant to rest for 1 hour before feeding. Data were collected during working hours
(08.00-16.00) to establish common physical environment conditions for each infant. The cup to
be used during feeding was sterilised with a steam steriliser. The heart rate and oxygen
saturation of the infants in both groups were recorded 30 minutes before the time of 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. All findings were
recorded on the "Feeding Monitoring Form".
After all steps before feeding were completed and recorded, the infant was loosely swaddled
with a soft cloth and started to be fed by being held only by the researcher in order to
prevent the effect of different feeding practices of the nurses on the study. As soon as
feeding was initiated, a stopwatch was activated by another nurse who worked in the clinic in
order to avoid any bias, and the feeding time was maintained not to exceed 30 minutes in
order to prevent the infant from getting tired. During the feeding period, heart rate and
oxygen saturation were continuously recorded. The infants in the control group were fed with
a cup. The cups currently used in the clinic for feeding were selected in a size suitable for
the preterm infant so that they would not damage the lips, palate and tongue. During feeding,
all infants in this group were placed in semi-elevated supine position. The cup was inserted
into the infant's lips and elevated until the milk reached the infant's mouth. 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 cup was not raised to allow the infant to slurp the milk more quickly and the milk
was not poured into his/her mouth, so that the infant was given complete control over the
feeding. 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. In case of signs of stress and fatigue, feeding was interrupted for a
short time and the infant was allowed to rest. 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, including the infants' resting times. When the infant was no
longer sucking, another nurse who worked in the clinic stopped the stopwatch in order to
prevent bias 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. After feeding, the body
weight of the infants was measured with only the diaper on and the test weight was
determined. After the procedure, the infant was put in the incubator in a right-side position
to facilitate gastric discharge. 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. The recorded data were classified
into pre-feeding, feeding, and post-feeding periods, entered into a computer environment, and
averaged. The amount of food taken by the infant during the 30-minute feeding period was
recorded, and if the infant was unable to take in the entire amount of food prescribed by the
physician, he/she took the remaining amount with an orogastric catheter after the
post-feeding measurements were finished.
