Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05154357 |
| Other study ID # |
E-74555795-050.01.04-88001 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 3, 2021 |
| Est. completion date |
July 5, 2022 |
Study information
| Verified date |
July 2022 |
| Source |
Istanbul University-Cerrahpasa |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The study will be conducted using the crossover randomized controlled method. Preterm infants
who began oral feeding from the neonatal intensive care unit will be divided into two groups
through randomization in the computer environment. Following the randomization, infants in
Group 1 will be fed by applying ''elastic sac'' at the first feeding hour after they are
included in the study and in the next feeding they will be fed without performing any
application. Infants in Group 2 will be fed without performing any application at the first
feeding hour after they are included in the study and they will be fed at the second feeding
hour by applying ''elastic sac''. Infants in both groups will be fed by the researcher with a
bottle in a semi-fowler right lateral position during feeding hours. During feeding, the
effect of the elastic sac on the infant's feeding status and physiological parameters will be
evaluated.
Description:
Swaddling method is a method which can be used for preserving thermoregulation, decreasing
stress and maintaining comfort in term and preterm infants during painful procedures. The
effect of the ''elastic sac'' method which is thought to imitate the uterus environment, on
physiological parameters and feeding performance of infants during feeding will be evaluated.
The ''elastic sac'' method will be applied with 100% cotton and elastic fabric. The
single-use elastic and cotton fabric was sewed as a U-shaped sac for each infant included in
the study. The infant will be placed in the sac during the feeding hour and will be placed in
a position in which he/she can move easily, maintain the flexion posture and feel safe
contrary to traditional swaddling. The purpose of the study is to evaluate stress-associated
physiological parameters and feeding status during oral feeding in preterm infants starting
oral feeding. The study will be conducted using the crossover randomized controlled method.
The sample size of the study was determined via the power analysis in accordance with the
results obtained from studies conducted via a similar research method. According to the
results of the analyses, a total of 26 preterm infants including 13 for each group will be
included in the study group. After informing the families of infants meeting the inclusion
criteria both in written and oral forms, the study will be conducted with mothers who agree
to participate in the study and their infants.
Application Stages GROUP 1
1. Feeding Time Half an hour before the feeding time, the infant's heart rate and oxygen
saturation will be recorded in the observation form. The infant will be placed in the
''elastic sac'' and the angle of the incubator bed will be elevated 45 degrees. He/she
will be laid in the right lateral position within the nest and will be allowed to take a
rest within the ''elastic sac'' until the feeding time (30 minutes). Giving priority to
breast milk, formula milk at optimum temperature will be prepared for infants without
breast milk. The nutrient amount ordered by the doctor will be put in the bottle. Ten
minutes before the feeding time, the infant's heart rate and oxygen saturation will be
recorded in the observation form every two minutes. At the feeding time, the bottle will
be approached to the infant's mouth for feeding in the semi-fowler right lateral
position at 45 degrees without making any change in his/her posture. As soon as the
infant begins to suck, the chronometer will be started and the infant's heart rate and
oxygen saturation will be recorded by another observer nurse every two minutes
throughout feeding. When the infant shows signs of fatigue (Spo2 less than 90, HR higher
than 160), the feeding will be discontinued and when the infant's HR fall below 160 and
spO2 increases above 90, the feeding will continue. The time of feeding will be limited
to a maximum of 30 minutes. When the infant stops feeding, the chronometer will be
stopped, the feeding will be terminated and the infant will be allowed to take a rest.
His/her heart rate and oxygen saturation will be recorded in the observation form every
two minutes for ten minutes. Then, the ''elastic sac'' application will be terminated
and an onesie will be put on the infant in line with the care procedures of the clinic
and he/she will be allowed to take a rest until the next feeding hour. The amount (cc)
of milk the infant receives from the ordered amount of the milk and the amount of
nutrient he/she receives in a minute will be calculated and recorded in the observation
form.
2. Feeding Time Half an hour before the feeding time, the infant's heart rate and oxygen
saturation will be recorded in the observation form. The angle of the incubator bed will
be elevated 45 degrees. Only an onesie will be put on the infant in line with the care
procedures of the clinic and no other application will be performed. He/she will be laid
in the right lateral position within the nest and will be allowed to take a rest until
the feeding time. In order to feed him/her the same nutrient at both feeding hours, the
same nutrient prepared at the previous feeding hour will be prepared at optimum
temperature. The nutrient amount ordered by the doctor will be put in the bottle. Ten
minutes before the feeding hour, the infant's heart rate and oxygen saturation will be
recorded in the observation form every two minutes. At the feeding hour, the bottle will
be approached to the infant's mouth for feeding in the semi-fowler right lateral
position at 45 degrees without making any change in his/her position. As soon as the
infant begins to suck, the chronometer will be started and the infant's heart rate and
oxygen saturation will be recorded by another observer nurse every two minutes
throughout feeding. When the infant shows signs of fatigue (Spo2 less than 90, HR higher
than 160), the feeding will be discontinued and when the infant's HR falls below 160 and
spO2 increases above 90, the feeding will continue. The time of feeding will be limited
to a maximum of 30 minutes. When the infant stops feeding, the chronometer will be
stopped, the feeding will be terminated and the infant will be allowed to take a rest.
His/her heart rate and oxygen saturation will be recorded in the observation form every
two minutes for ten minutes. The infant will be allowed to take a rest in line with the
care procedures of the clinic. The amount (cc) of milk the infant receives from the
ordered amount of the milk and the amount of nutrient he/she receives in a minute will
be calculated and recorded in the observation form.
GROUP 2
1. Feeding Time Half an hour before the feeding time, the infant's heart rate and oxygen
saturation will be recorded in the observation form. The angle of the incubator bed will
be elevated 45 degrees. Only an onesie will be put on the infant in line with the care
procedures of the clinic and no other application will be performed. He/she will be laid
in the right lateral position within the nest and will be allowed to take a rest until
the feeding time (30 minutes). Giving priority to breast milk, formula milk at optimum
temperature will be prepared for infants without breast milk. The nutrient amount
ordered by the doctor will be put in the bottle. Ten minutes before the feeding hour,
the infant's heart rate and oxygen saturation will be recorded in the observation form
every two minutes. At the feeding hour, the bottle will be approached to the infant's
mouth for feeding in the semi-fowler right lateral position at 45 degrees without making
any change in his/her position. As soon as the infant begins to suck, the chronometer
will be started and the infant's heart rate and oxygen saturation will be recorded by
another observer nurse every two minutes throughout feeding. When the infant shows signs
of fatigue (Spo2 less than 90, HR higher than 160), the feeding will be discontinued and
when the infant's HR falls below 160 and spO2 increases above 90, the feeding will
continue. The time of feeding will be limited to a maximum of 30 minutes. When the
infant stops feeding, the chronometer will be stopped, the feeding will be terminated
and the infant will be allowed to take a rest. His/her heart rate and oxygen saturation
will be recorded in the observation form every two minutes for ten minutes. The infant
will be allowed to take a rest until the next feeding hour in line with the care
procedures of the clinic. Amount (cc) of milk the infant receives from the ordered
amount of the milk and the amount of nutrient he/she receives in a minute will be
calculated and recorded in the record form.
2. Feeding Time Half an hour before the feeding time, the infant's heart rate and oxygen
saturation will be recorded in the observation form. The infant will be placed in the
''elastic sac'' and the angle of the incubator bed will be elevated 45 degrees. He/she
will be laid in the right lateral position within the nest and will be allowed to take a
rest within the elastic sac until the feeding time. In order to feed him/her the same
nutrient at both feeding hours, the same nutrient prepared during the previous feeding
hour will be prepared at optimum temperature. The nutrient amount ordered by the doctor
will be put in the bottle. Ten minutes before the feeding time, the infant's heart rate
and oxygen saturation will be recorded in the observation form every two minutes. At the
feeding time, the bottle will be approached to the infant's mouth for feeding in the
semi-fowler right lateral position at 45 degrees without making any change in his/her
position. As soon as the infant begins to suck, the chronometer will be started and the
infant's heart rate and oxygen saturation will be recorded by another observer nurse
every two minutes throughout feeding. When the infant shows signs of fatigue (Spo2 less
than 90, HR higher than 160), the feeding will be discontinued and when the infant's HR
falls below 160 and spO2 increases above 90, the feeding will continue. The time of
feeding will be limited to a maximum of 30 minutes. When the infant stops feeding, the
chronometer will be stopped, the feeding will be terminated and the infant will be
allowed to take a rest. His/her heart rate and oxygen saturation will be recorded in the
observation form every two minutes for ten minutes. Then, the ''elastic sac''
application will be terminated and he/she will be allowed to take a rest in line with
the care procedures of the clinic. The amount (cc) of milk the infant receives from the
ordered amount of the milk and the amount of nutrient he/she receives in a minute will
be calculated and recorded in the observation form.
