Premature BirthNCT07881653
Post-Care Positioning and Comfort in Late Preterm Infants
A study testing Sequential post-care positioning in people with Premature Birth and Premature, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
This study examined the comfort of late preterm infants (born at 34 0/7 to 36 6/7 weeks of gestation) placed in four positions after routine nursing care in a neonatal intensive care unit. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Premature Birth, Premature
- What is being tested?
- Sequential post-care positioning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2026to 30 May 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Born at 34 0/7 to 36 6/7 weeks of gestation
- No painful procedure in the 2 hours before positioning
- No medication other than vitamin and mineral supplements
- Written informed consent from a parent
Who cannot join
- Congenital anomaly
- Metabolic disease
- Mechanical ventilation
- Umbilical catheter
- Medication other than vitamin and mineral supplements
- Need for a painful procedure during the observation period
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gulhane Training and Research Hospital, Neonatal Intensive Care Unit, Ankara, Türkiye
Ankara, Ankara, 06010
About this study
Official title: Effect of Positions Applied After Routine Nursing Care on the Comfort of Late Preterm Infants in the Neonatal Intensive Care Unit: A Within-Subject Quasi-Experimental Study
This study examined the comfort of late preterm infants (born at 34 0/7 to 36 6/7 weeks of gestation) placed in four positions after routine nursing care in a neonatal intensive care unit. After each of four night-time care episodes, every infant was placed sequentially in the supine, left lateral, right lateral and prone positions within a nest for 15 minutes each, and comfort was assessed with the Premature Infant Comfort Scale at the 1st, 5th and 15th minutes.
Read the detailed description
Single-group, within-subject, repeated-measures quasi-experimental study conducted in the level III neonatal intensive care unit of a tertiary training and research hospital in Ankara, Türkiye. Fifty spontaneously breathing, clinically stable late preterm infants were enrolled after written parental consent. Data were collected during the night shift. Routine nursing care was given every 3 hours, and observations followed the care episodes at 19:00, 22:00, 01:00 and 04:00. After each care episode, infants were placed in a fixed order in the supine, left lateral, right lateral and prone positions, within a U-shaped nest, with the head and trunk aligned in the midline, the neck in slight flexion and the head of the bed elevated by 30 degrees. Each position was maintained for 15 minutes. The Premature Infant Comfort Scale (PICS; total score 7-35, lower scores indicate greater comfort, 17 or more indicates discomfort) was scored at the 1st, 5th and 15th minutes, yielding 48 observations per infant. Infants were continuously monitored with a cardiorespiratory monitor. No painful procedure was performed during the observation period. All positioning and scoring were carried out by the same researcher, a neonatal intensive care nurse. Data were analyzed with repeated-measures ANOVA.
- Conditions
- Premature Birth, Premature
- Being tested
- Sequential post-care positioning
- Keywords
- patient positioning, late preterm infant, comfort, NICU
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sequential post-care positioningOther
After routine nursing care, the infant was placed within a U-shaped nest in the supine, left lateral, right lateral and prone positions, in this order, for 15 minutes each, with midline head-trunk alignment, slight neck flexion and 30-degree head-of-bed elevation
| Study group | Role | What they receive |
|---|---|---|
| Post-care positioning | Experimental | Late preterm infants placed sequentially in the supine, left lateral, right lateral and prone positions (15 minutes each) after each of four routine night-time care episodes. Receives: Other: Sequential post-care positioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Premature Infant Comfort Scale (PICS) total score
Seven items (alertness, calmness/agitation, crying, physical movement, muscle tone, facial tension, mean heart rate), each scored 1-5; total 7-35. Lower scores indicate greater comfort; a score of 17 or more indicates discomfort.
Measured: At the 1st, 5th and 15th minutes after placement in each of the four positions, following each of four night-time care episodes (19:00, 22:00, 01:00 and 04:00) during one night
Secondary outcomes (2)
PICS dimension scores
Scores of each of the seven PICS items (range 1-5; lower scores indicate greater comfort).
Measured: At the 1st, 5th and 15th minutes after placement in each of the four positions, following each of four night-time care episodes (19:00, 22:00, 01:00 and 04:00) during one night
Number of infants with discomfort (PICS total score of 17 or more)
Number of infants with a PICS total score of 17 or more, which indicates discomfort requiring intervention (PICS range 7-35; lower scores indicate greater comfort).
Measured: At the 1st, 5th and 15th minutes after placement in each of the four positions, following each of four night-time care episodes (19:00, 22:00, 01:00 and 04:00) during one night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start1 Feb 2026
- Primary completion15 May 2026
- Study completion30 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- All infants received all four positions (supine, left lateral, right lateral, prone) in the same fixed order after each of four night-time care episodes.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kardelen Köroğlu, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07881653
- Sponsor's protocol ID
- 2026-039
- Other IDs
- BADEK-2025-23
- Status last verified
- Oct 2026
- First submitted
- 3 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified data may be made available by the corresponding author upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Positions Applied After Routine Nursing Care on the Comfort of Late Preterm Infants in the Neonatal Intensive Care Unit: A Within-Subject Quasi-Experimental Study
- ClinicalTrials.gov ID
- NCT07881653
- Acronym / sponsor ID
- 2026-039
- Conditions
- Premature Birth, Premature
- Keywords
- patient positioning, late preterm infant, comfort, NICU
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 15 May 2026 (actual)
- Study completion
- 30 May 2026 (actual)
- First posted
- 19 Oct 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 study examined the comfort of late preterm infants (born at 34 0/7 to 36 6/7 weeks of gestation) placed in four positions after routine nursing care in a neonatal intensive care unit. After each of four night-time care episodes, every infant was placed sequentially in the supine, left lateral, right lateral and prone positions within a nest for 15 minutes each, and comfort was assessed with the Premature Infant Comfort Scale at the 1st, 5th and 15th minutes.
Detailed description
Single-group, within-subject, repeated-measures quasi-experimental study conducted in the level III neonatal intensive care unit of a tertiary training and research hospital in Ankara, Türkiye. Fifty spontaneously breathing, clinically stable late preterm infants were enrolled after written parental consent. Data were collected during the night shift. Routine nursing care was given every 3 hours, and observations followed the care episodes at 19:00, 22:00, 01:00 and 04:00. After each care episode, infants were placed in a fixed order in the supine, left lateral, right lateral and prone positions, within a U-shaped nest, with the head and trunk aligned in the midline, the neck in slight flexion and the head of the bed elevated by 30 degrees. Each position was maintained for 15 minutes. The Premature Infant Comfort Scale (PICS; total score 7-35, lower scores indicate greater comfort, 17 or more indicates discomfort) was scored at the 1st, 5th and 15th minutes, yielding 48 observations per infant. Infants were continuously monitored with a cardiorespiratory monitor. No painful procedure was performed during the observation period. All positioning and scoring were carried out by the same researcher, a neonatal intensive care nurse. Data were analyzed with repeated-measures ANOVA.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All infants received all four positions (supine, left lateral, right lateral, prone) in the same fixed order after each of four night-time care episodes.
| Arm | Type | Receives |
|---|---|---|
| Post-care positioning | Experimental | Other: Sequential post-care positioningLate preterm infants placed sequentially in the supine, left lateral, right lateral and prone positions (15 minutes each) after each of four routine night-time care episodes. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Born at 34 0/7 to 36 6/7 weeks of gestation
- No painful procedure in the 2 hours before positioning
- No medication other than vitamin and mineral supplements
- Written informed consent from a parent
Key exclusion criteria (6 listed)
- Congenital anomaly
- Metabolic disease
- Mechanical ventilation
- Umbilical catheter
- Medication other than vitamin and mineral supplements
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 |
|---|---|---|
| Sequential post-care positioningAfter routine nursing care, the infant was placed within a U-shaped nest in the supine, left lateral, right lateral and prone positions, in this order, for 15 minutes each, with midline head-trunk alignment, slight neck flexion and 30-degree head-of-bed elevation | Other | Post-care positioning |
Primary outcome
Premature Infant Comfort Scale (PICS) total score
Time frame: At the 1st, 5th and 15th minutes after placement in each of the four positions, following each of four night-time care episodes (19:00, 22:00, 01:00 and 04:00) during one night
Seven items (alertness, calmness/agitation, crying, physical movement, muscle tone, facial tension, mean heart rate), each scored 1-5; total 7-35. Lower scores indicate greater comfort; a score of 17 or more indicates discomfort.
2 secondary outcomes
PICS dimension scores
Time frame: At the 1st, 5th and 15th minutes after placement in each of the four positions, following each of four night-time care episodes (19:00, 22:00, 01:00 and 04:00) during one night
Number of infants with discomfort (PICS total score of 17 or more)
Time frame: At the 1st, 5th and 15th minutes after placement in each of the four positions, following each of four night-time care episodes (19:00, 22:00, 01:00 and 04:00) during one night
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 19 Oct 2026.
- Individual participant dataSharing planned: No. De-identified data may be made available by the corresponding author upon reasonable request.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sequential post-care positioning in people with Premature Birth and Premature, run by Saglik Bilimleri Universitesi 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 4 inclusion and 6 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 19 Oct 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?
Premature Infant Comfort Scale (PICS) total score (time frame: At the 1st, 5th and 15th minutes after placement in each of the four positions, following each of four night-time care episodes (19:00, 22:00, 01:00 and 04:00) during one night). 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 19 Oct 2026.