About this trial
This study will be conducted as a randomized controlled crossover study to evaluate the effects of different positions during skin-to-skin contact on physiological parameters, comfort, and feeding tolerance in preterm infants receiving orogastric feeding. Preterm infants who meet the eligibility criteria will be included in the study. Each infant will receive orogastric feeding while being held in different positions during skin-to-skin contact, according to the assigned sequence. Physiological parameters, including heart rate, oxygen saturation, respiratory rate, and body temperature, will be assessed during the feeding sessions. Infants' comfort levels will be evaluated using the Neonatal Comfort Behavior Scale, and feeding tolerance will be assessed based on clinical signs and abdominal measurements. The findings will be compared across the different positioning conditions to determine their effects on physiological stability, comfort, and feeding tolerance in preterm infants.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
The infant must have been born between the 28th and 34th weeks of gestation.
The infant must be between 30 and 34 postmenstrual weeks at the time of enrollment in the study.
The infant's body weight must be at least 1,000 grams at the time of enrollment in the study.
The infant must have a confirmed need for total enteral feeding via an orogastric tube, as verified by a physician.
Disqualifiers
Presence of a gastrointestinal, neurological, cardiovascular, or genetic disease or congenital anomaly (e.g., NEK, IVK, hydrocephalus, asphyxia, Down syndrome, short bowel syndrome, cleft palate/lip, etc.).
A history of invasive procedures (such as surgical interventions) that could cause prolonged discomfort or pain.
The infant's need for oxygen support.
Feeding maintained via nasogastric, gastrostomy, or transpyloric methods.
Trial design
Crossover
Treatments tested in this trial
Skin-to-Skin Contact in a Semi-Elevated Right Lateral Position
Other interventionFive minutes before the feeding time, the infant's comfort level, physiological parameters, and abdominal circumference will be assessed and recorded while the infant is in the incubator. The infant will then receive diaper care and will be removed from the incubator wearing only a diaper. Skin-to-skin contact will be initiated by placing the infant on the mother's chest in a semi-elevated right lateral position. The infant will remain in skin-to-skin contact with the mother for a total of 30 minutes. Five minutes after positioning, orogastric feeding will be administered by the researcher. During feeding, the infant will remain in the same position. Physiological parameters and comfort level will be assessed at predefined time points before, during, and after feeding. After completion of the feeding and the intervention, the infant will be returned to the incubator and positioned in the right lateral position until the ne
Skin-to-Skin Contact in an Upright Position
Other interventionFive minutes before the feeding time, the infant's comfort level, physiological parameters, and abdominal circumference will be assessed and recorded while the infant is in the incubator. The infant will then receive diaper care and will be removed from the incubator wearing only a diaper. The infant will be placed on the mother's chest in an upright position for skin-to-skin contact. The infant will remain in skin-to-skin contact with the mother for a total of 30 minutes. Five minutes after positioning, the infant will be fed by the researcher through an orogastric tube without changing the infant's position. Physiological parameters and comfort level will be assessed at predefined time points during and after feeding. After completion of the intervention, the infant will be returned to the incubator and positioned in the right lateral position until the next feeding session.
Control
Other interventionFive minutes before the feeding time, the infant's comfort level, physiological parameters, and abdominal circumference will be assessed and recorded while the infant is in the incubator. The infant will then receive diaper care and will remain in the incubator in a semi-elevated right lateral position without skin-to-skin contact or any additional intervention. The head of the incubator will be elevated to approximately 45 degrees. The infant will be positioned on the right side and supported with routine nesting to maintain the position. Five minutes after positioning, the infant will be fed by the researcher through an orogastric tube without changing the infant's position. Physiological parameters and comfort level will be assessed at predefined time points during and after feeding. After feeding, the infant will remain in the incubator in the right lateral position until the next feeding session.
Treatment groups
Trial outcomes
Primary outcomes
Oxygen Saturation
Oxygen saturation will be measured using pulse oximetry and reported as a percentage (%).
Heart Rate
Heart rate will be measured using pulse oximetry and reported as beats per minute (bpm).
COMFORTneo Scale Score
Comfort will be assessed using the COMFORTneo Scale. The scale consists of six items, with total scores ranging from 6 to 30. Lower scores indicate greater comfort, whereas higher scores indicate greater distress.
Secondary outcomes
Abdominal Circumference
Abdominal circumference will be measured in centimeters (cm) using a non-stretchable measuring tape.
Clinical Signs of Feeding Intolerance
Clinical signs of feeding intolerance will be assessed based on the presence of predefined clinical signs, including vomiting, regurgitation, abdominal distension. The outcome will be reported as the number of clinical signs present.
Locations
Sponsors and contacts
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Istanbul University - Cerrahpasa
Lead sponsor
Marmara University
Sponsor institution
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