Prematurity, Mechanical VentilationNCT07845435
Effects of Therapeutic Positioning in Mechanically Ventilated Preterm Infants
A study testing Supine Position, Prone Position and Fetal Position in people with Prematurity, Mechanical Ventilation, run by Mustafa Kemal University at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 35 to 37 weeks
- Conditions the study is for
- Prematurity, Mechanical Ventilation
- What is being tested?
- Supine Position, Prone Position and Fetal Position
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Feb 2024to 30 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 35 to 37 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infants born between 35 and 37 weeks of gestation
- Receiving invasive or non-invasive mechanical ventilatory support
- Clinically stable before positioning
- No additional comfort-enhancing intervention administered during the study assessment period
- Written informed consent provided by a parent or legal guardian
Who cannot join
- Gestational age below 35 weeks or above 37 weeks
- Receiving phototherapy during the study assessment period
- Presence of a congenital anomaly
- Receiving sedative medication
- Clinical instability preventing the application of the assigned position
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effects of Therapeutic Positioning on Physiological Parameters, Comfort, and Pain Levels in Premature Neonates on Mechanical Ventilation: A Randomized Controlled Study
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.
Read the detailed description
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.
- Conditions
- Prematurity, Mechanical Ventilation
- Being tested
- Supine Position, Prone Position, Fetal Position
- Keywords
- Preterm Infant, Mechanical Ventilation, Therapeutic Positioning
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supine PositionOther
Standardized placement of the mechanically ventilated preterm infant in the supine position for three hours.
Prone PositionOther
Standardized placement of the mechanically ventilated preterm infant in the prone position, with support of the trunk and pelvis, for three hours.
Fetal PositionOther
Standardized flexion-based positioning of the mechanically ventilated preterm infant using appropriate support materials to mimic the intrauterine posture for three hours.
| Study group | Role | What they receive |
|---|---|---|
| Supine Position | Experimental | 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. Receives: Other: Prone Position; Other: Fetal Position |
| Prone Position | Active comparator | 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. Receives: Other: Supine Position; Other: Fetal Position |
| Fetal Position | Active comparator | 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. Receives: Other: Supine Position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Level Assessed Using the Premature Infant Pain Profile-Revised
Pain Level Assessed Using the Premature Infant Pain Profile-Revised
Measured: Baseline, 30 minutes, 2 hours, and 3 hours after positioning
Secondary outcomes (1)
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.
Measured: Baseline, 30 minutes, 2 hours, and 3 hours after positioning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start7 Feb 2024
- Primary completion7 Feb 2025
- Study completion30 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prematurity, Mechanical VentilationStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mustafa Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, EMEL DEMIR, Mustafa Kemal University
- Investigators
- Rana Rehap SERT, Principal investigator, Istanbul Sabahattin Zaim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07845435
- Sponsor's protocol ID
- 15
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Therapeutic Positioning on Physiological Parameters, Comfort, and Pain Levels in Premature Neonates on Mechanical Ventilation: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07845435
- Acronym / sponsor ID
- 15
- Conditions
- Prematurity, Mechanical Ventilation
- Keywords
- Preterm Infant, Mechanical Ventilation, Therapeutic Positioning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mustafa Kemal UniversityUniversity, hospital or other
- Study start
- 7 Feb 2024 (actual)
- Primary completion
- 7 Feb 2025 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 28 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Supine Position | Experimental | Other: Prone Position, Other: Fetal PositionInfants 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. |
| Prone Position | Active comparator | Other: Supine Position, Other: Fetal PositionInfants 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. |
| Fetal Position | Active comparator | Other: Supine PositionInfants 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. |
Who may qualify
- Ages
- 35 to 37 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Preterm infants born between 35 and 37 weeks of gestation
- Receiving invasive or non-invasive mechanical ventilatory support
- Clinically stable before positioning
- No additional comfort-enhancing intervention administered during the study assessment period
- Written informed consent provided by a parent or legal guardian
Key exclusion criteria (5 listed)
- Gestational age below 35 weeks or above 37 weeks
- Receiving phototherapy during the study assessment period
- Presence of a congenital anomaly
- Receiving sedative medication
- Clinical instability preventing the application of the assigned position
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supine PositionStandardized placement of the mechanically ventilated preterm infant in the supine position for three hours. | Other | Fetal Position, Prone Position |
| Prone PositionStandardized placement of the mechanically ventilated preterm infant in the prone position, with support of the trunk and pelvis, for three hours. | Other | Supine Position |
| Fetal PositionStandardized flexion-based positioning of the mechanically ventilated preterm infant using appropriate support materials to mimic the intrauterine posture for three hours. | Other | Prone Position, Supine Position |
Primary outcome
Pain Level Assessed Using the Premature Infant Pain Profile-Revised
Time frame: Baseline, 30 minutes, 2 hours, and 3 hours after positioning
Pain Level Assessed Using the Premature Infant Pain Profile-Revised
1 secondary outcome
Comfort Level Assessed Using the COMFORTneo Scale
Time frame: Baseline, 30 minutes, 2 hours, and 3 hours after positioning
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rana Rehap SERT principal investigator
Istanbul Sabahattin Zaim University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supine Position, Prone Position and Fetal Position in people with Prematurity, Mechanical Ventilation, run by Mustafa Kemal University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Level Assessed Using the Premature Infant Pain Profile-Revised (time frame: Baseline, 30 minutes, 2 hours, and 3 hours after positioning). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.