Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05802095 |
| Other study ID # |
Urfa |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 2, 2023 |
| Est. completion date |
November 20, 2023 |
Study information
| Verified date |
May 2024 |
| Source |
Medipol University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The research will be carried out as a randomized controlled experimental design to evaluate
the effectiveness of the breastfeeding support system to increase sucking success in
premature infants receiving care in the NICU and breastfeeding self-efficacy in mothers.
In the study, the experimental and control groups will be determined by randomization of
premature babies hospitalized in the NICU. While the babies in the control group will be fed
with the routine feeding method (bottle) of the NICU, the babies in the experimental group
will be fed with the breastfeeding support system by their mother. Research data will be
collected using the Premature Baby and Its Mother Information Form, Premature Baby Follow-up
Form, LATCH Breastfeeding Diagnostic Scale and Breastfeeding Self-Efficacy Scale-Short Form.
Description:
Premature babies have to cope with many problems in the neonatal intensive care unit (NICU)
in the postnatal period, and feeding problems are the leading of these problems. Oral feeding
of premature infants is a complex and dynamic process consisting of the interaction of
oral-motor, neurological, cardiorespiratory and gastrointestinal systems. Because they are
anatomically and physiologically immature, they often cannot coordinate their sucking,
swallowing and respiration for oral feeding, and they often have difficulty in oral feeding.
Therefore, feeding premature babies in the NICU is provided by an orogastric or nasogastric
tube. Continuing the feeding with the gavage method for a long time causes a delay in the
acquisition of the motor skills required for oral feeding. Therefore, premature babies should
be switched to oral feeding when they are physiologically ready. It is known that growth and
developmental retardation are seen in premature babies if appropriate and adequate nutrition
is not provided on time.
The most basic criterion sought in the transition to oral feeding in premature babies is the
development of feeding skills. Different oral stimulus interventions have been developed to
support and strengthen the development of oral-motor functions, create sufficient suction
power, and start oral nutrition earlier. Tactile/kinesthetic stimulation, oral stimulation,
swallowing exercises, non-nutritive sucking, gentle pressure on the cheeks, lips, chin and
palate are among the most common sensorimotor interventions. It is reported that these
interventions accelerate the transition time to oral feeding. Successful sucking transition
from gavage to full oral feeding is one of the most important determinants of both discharges
from the NICU and the growth and development of premature infants. This study will evaluate
the effect of the breastfeeding support system used in premature babies on the baby's sucking
success and the mother's breastfeeding self-efficacy.
The research will be carried out as a randomized controlled experimental design to evaluate
the effectiveness of the breastfeeding support system to increase sucking success in
premature infants receiving care in the NICU and breastfeeding self-efficacy in mothers.
In the study, the experimental and control groups will be determined by randomization of
premature babies hospitalized in the NICU. While the babies in the control group will be fed
with the routine feeding method (bottle) of the NICU, the babies in the experimental group
will be fed with the breastfeeding support system by their mother. Research data will be
collected using the Premature Baby and Its Mother Information Form, Premature Baby Follow-up
Form, LATCH Breastfeeding Diagnostic Scale and Breastfeeding Self-Efficacy Scale-Short Form.
