An interventional study of Supine Position and Prone Position in Prematurity, Mechanical Ventilation, sponsored by Mustafa Kemal University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 35 Weeks to 37 Weeks. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by Mustafa Kemal University · Not applicable, Interventional, and Supportive care
This randomized controlled trial evaluated the effects of three therapeutic positions on physiological parameters, pain, and comfort in mechanically ventilated preterm infants. A total of 60 preterm infants born between 35 and 37 weeks of gestation were randomly assigned to the supine, prone, or fetal position group, with 20 infants in each group. Physiological parameters, pain, and comfort were assessed at baseline, 30 minutes, 2 hours, and 3 hours after positioning. Pain was assessed using the Premature Infant Pain Profile-Revised, and comfort was assessed using the COMFORTneo scale.
Preterm infants receiving mechanical ventilation are exposed to physiological instability, pain, environmental stressors, and reduced comfort during neonatal intensive care. Therapeutic positioning is a non-pharmacological nursing intervention that may support oxygenation, physiological stability, neurobehavioral organization, and comfort.
This three-arm, parallel-group randomized controlled trial was conducted among mechanically ventilated preterm infants born between 35 and 37 weeks of gestation. Infants meeting the eligibility criteria were randomly assigned in a 1:1:1 ratio to the supine position, prone position, or fetal position group. Randomization was performed using a computer-generated random number sequence by an independent researcher.
The assigned position was applied according to a standardized positioning protocol. Ventilator settings were not changed as part of the positioning intervention. Physiological parameters, including heart rate, respiratory rate, peripheral oxygen saturation, and body temperature, were recorded at baseline, 30 minutes, 2 hours, and 3 hours. Pain was assessed using the Premature Infant Pain Profile-Revised, and comfort was assessed using the COMFORTneo scale at the same time points.
The study was designed to determine whether prone and fetal positioning improve physiological stability, reduce pain, and increase comfort compared with routine supine positioning in mechanically ventilated preterm infants.
2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
This study's enrollment of 60 is below the median of 84 across 1,689 interventional studies indexed under Premature Birth.
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Exclusion Criteria:
Infants assigned to the control group were placed in the supine position. The infant was positioned on the back, with the head maintained in the midline, according to the standardized positioning protocol. The position was maintained during the three-hour assessment period.
Other: Prone Position · Other: Fetal Position
Infants assigned to this group were placed in the prone position. The trunk and pelvis were supported, and the head was turned slightly to one side according to the standardized positioning protocol. The position was maintained during the three-hour assessment period.
Other: Supine Position · Other: Fetal Position
Infants assigned to this group were placed in a flexion-based fetal position. The upper and lower extremities were maintained in flexion, and appropriate positioning supports were used to mimic the intrauterine posture. The position was maintained during the three-hour assessment period.
Other: Supine Position
Standardized placement of the mechanically ventilated preterm infant in the supine position for three hours.
Standardized placement of the mechanically ventilated preterm infant in the prone position, with support of the trunk and pelvis, for three hours.
Standardized flexion-based positioning of the mechanically ventilated preterm infant using appropriate support materials to mimic the intrauterine posture for three hours.
Pain Level Assessed Using the Premature Infant Pain Profile-Revised
Pain Level Assessed Using the Premature Infant Pain Profile-Revised
Time frame: Baseline, 30 minutes, 2 hours, and 3 hours after positioning
Comfort Level Assessed Using the COMFORTneo Scale
Comfort was assessed using the COMFORTneo scale. The scale evaluates alertness, calmness or agitation, respiratory response or crying, body movement, muscle tone, and facial tension. The total score ranges from 6 to 30, with higher scores indicating greater distress and lower comfort.
Time frame: Baseline, 30 minutes, 2 hours, and 3 hours after positioning
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Mustafa Kemal University