Preterm InfantsNCT07857512
Effects of Different Positions During Skin-to-Skin Contact in Preterm Infants Receiving Orogastric Feeding
A study testing Skin-to-Skin Contact in a Semi-Elevated Right Lateral Position and Skin-to-Skin Contact in an Upright Position in people with Preterm Infants and Orogastric Feeding, run by Istanbul University - Cerrahpasa.
Trial 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. Read more about this study
- Who is it for?
- Ages 28 to 34 weeksHealthy volunteers can take part
- Conditions the study is for
- Preterm Infants, Orogastric Feeding, Feeding Tolerance
- What is being tested?
- Skin-to-Skin Contact in a Semi-Elevated Right Lateral Position and Skin-to-Skin Contact in an Upright Position
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- 23 Oct 2026to 23 Jun 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 to 34 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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,
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Birsen Mutlu, PhD contact
About this study
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
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.
- Being tested
- Skin-to-Skin Contact in a Semi-Elevated Right Lateral Position, Skin-to-Skin Contact in an Upright Position, Control
- Keywords
- Preterm Infants, Skin-to-Skin Contact, Orogastric Feeding, Feeding Tolerance, Physiological Parameters
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin-to-Skin Contact in a Semi-Elevated Right Lateral PositionOther
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
Skin-to-Skin Contact in an Upright PositionOther
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.
ControlOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (CAB Sequence) | Experimental | 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. Receives: Other: Skin-to-Skin Contact in a Semi-Elevated Right Lateral Position; Other: Skin-to-Skin Contact in an Upright Position; Other: Control |
| Group 2 (CBA Sequence) | Experimental | 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. Receives: Other: Skin-to-Skin Contact in a Semi-Elevated Right Lateral Position; Other: Skin-to-Skin Contact in an Upright Position; Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen Saturation
Oxygen saturation will be measured using pulse oximetry and reported as a percentage (%).
Measured: 5 minutes before feeding; 1 and 5 minutes during feeding; and 1, 5, 60, and 120 minutes after feeding
Heart Rate
Heart rate will be measured using pulse oximetry and reported as beats per minute (bpm).
Measured: 5 minutes before feeding; 1 and 5 minutes during feeding; and 1, 5, 60, and 120 minutes after feeding
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.
Measured: 5 minutes before feeding; 1 minutes during feeding; and 5 and 60 minutes after feeding
Secondary outcomes (2)
Abdominal Circumference
Abdominal circumference will be measured in centimeters (cm) using a non-stretchable measuring tape.
Measured: 5 minutes before feeding, and 1 and 2 hours after feeding
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.
Measured: 5 minutes before feeding, and for 2 hours after feeding
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start23 Oct 2026 (estimated)
- Primary completion23 Apr 2027 (estimated)
- Study completion23 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm InfantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Canan Genç, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07857512
- Sponsor's protocol ID
- E-83460662-050.04-1708577
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No