Effects of Different Positions During Skin-to-Skin Contact in Preterm Infants Receiving Orogastric Feeding
The Effect of Positions Given During Skin-to-Skin Contact on Physiological Parameters, Comfort and Feeding Tolerance in Orogastric Feeding of Preterm Infants
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.
Przegląd badań
Status
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Canan Genç, MSc
- Numer telefonu: 05372828808
- E-mail: cananuzun5561@gmail.com
Kopia zapasowa kontaktu do badania
- Nazwa: Birsen Mutlu, PhD
- E-mail: bdonmez@iuc.edu.tr
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Randomizowane
- Model interwencyjny: Zadanie krzyżowe
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Group 1 (CAB Sequence)
Participants assigned to Group 1 will receive three orogastric feeding sessions in the following order: Control (C), Intervention A, and Intervention B. During the first feeding session, the infant will remain in the incubator in a semi-elevated right lateral position without skin-to-skin contact. During the second feeding session, the infant will receive skin-to-skin contact with the mother in a semi-elevated right lateral position. During the third feeding session, the infant will receive skin-to-skin contact with the mother in an upright position. Before each feeding session, the infant's physiological parameters, comfort level, and abdominal circumference will be assessed and recorded. Orogastric feeding will be administered by the researcher five minutes after the assigned positioning or initiation of skin-to-skin contact. Physiological parameters and comfort level will be assessed during and after feeding, and feeding duration and feeding tolerance will be recorded. |
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 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. 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. |
|
Eksperymentalny: Group 2 (CBA Sequence)
Participants assigned to Group 2 will receive three orogastric feeding sessions in the following order: Control (C), Intervention B, and Intervention A. During the first feeding session, the infant will remain in the incubator in a semi-elevated right lateral position without skin-to-skin contact. During the second feeding session, the infant will receive skin-to-skin contact with the mother in an upright position. During the third feeding session, the infant will receive skin-to-skin contact with the mother in a semi-elevated right lateral position. Before each feeding session, the infant's physiological parameters, comfort level, and abdominal circumference will be assessed and recorded. Orogastric feeding will be administered by the researcher five minutes after the assigned positioning or initiation of skin-to-skin contact. Physiological parameters and comfort level will be assessed during and after feeding, and feeding duration and feeding tolerance will be recorded. |
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 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. 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. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Oxygen Saturation
Ramy czasowe: 5 minutes before feeding; 1 and 5 minutes during feeding; and 1, 5, 60, and 120 minutes after feeding
|
Oxygen saturation will be measured using pulse oximetry and reported as a percentage (%). |
5 minutes before feeding; 1 and 5 minutes during feeding; and 1, 5, 60, and 120 minutes after feeding
|
|
Heart Rate
Ramy czasowe: 5 minutes before feeding; 1 and 5 minutes during feeding; and 1, 5, 60, and 120 minutes after feeding
|
Heart rate will be measured using pulse oximetry and reported as beats per minute (bpm). |
5 minutes before feeding; 1 and 5 minutes during feeding; and 1, 5, 60, and 120 minutes after feeding
|
|
COMFORTneo Scale Score
Ramy czasowe: 5 minutes before feeding; 1 minutes during feeding; and 5 and 60 minutes after feeding
|
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. |
5 minutes before feeding; 1 minutes during feeding; and 5 and 60 minutes after feeding
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Abdominal Circumference
Ramy czasowe: 5 minutes before feeding, and 1 and 2 hours after feeding
|
Abdominal circumference will be measured in centimeters (cm) using a non-stretchable measuring tape. |
5 minutes before feeding, and 1 and 2 hours after feeding
|
|
Clinical Signs of Feeding Intolerance
Ramy czasowe: 5 minutes before feeding, and for 2 hours after feeding
|
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. |
5 minutes before feeding, and for 2 hours after feeding
|
Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- E-83460662-050.04-1708577
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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