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NCT07857512

Effects of Different Positions During Skin-to-Skin Contact in Preterm Infants Receiving Orogastric Feeding

Sponsor: Istanbul University - Cerrahpasa

View on ClinicalTrials.gov

Summary

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.

Official title: The Effect of Positions Given During Skin-to-Skin Contact on Physiological Parameters, Comfort and Feeding Tolerance in Orogastric Feeding of Preterm Infants

Key Details

Gender

All

Age Range

28 Weeks - 34 Weeks

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-10-23

Completion Date

2027-06-23

Last Updated

2026-10-05

Healthy Volunteers

Yes

Conditions

Preterm Infants Orogastric Feeding Feeding Tolerance Skin to Skin Contact

Interventions

OTHER

Skin-to-Skin Contact in a Semi-Elevated Right Lateral Position

Five 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

OTHER

Skin-to-Skin Contact in an Upright Position

Five 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.

OTHER

Control

Five 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.

Inclusion Criteria: * 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. * The infant must not have yet transitioned to oral feeding at the start of the study. * The infant's vital signs must be stable prior to feeding (heart rate 100-160 beats/min, respiratory rate \<60/min, and axillary temperature 36.5-37.4°C). * The infant must have no additional medical diagnoses other than prematurity. * The infant must have received enteral feeding at 3-hour intervals for at least 24 hours. * No painful procedure must have been performed within 1 hour prior to the study; furthermore, the infant must not have received any sedatives, muscle relaxants, or analgesics within the past 24 hours. * Feeding must consist solely of breast milk, * Infants will meet the sample selection criteria if their parents voluntarily agree to participate in the study. Exclusion Criteria: * 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. * The occurrence of vomiting during feeding. * If an invasive procedure is performed on the infant during the data collection process, * If the infant's orogastric tube dislodges during the data collection process and reinsertion is required, * If the infant requires total parenteral nutrition, * Infants with a history of grade 3 or 4 intraventricular hemorrhage will not be included in the study.

Clinical Research Directory

Effects of Different Positions During Skin-to-Skin Contact in Preterm Infants Receiving Orogastric Feeding

Summary

Key Details

Conditions

Interventions

Eligibility Criteria