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CompletedNCT07881653Updated Oct 19, 2026

Post-Care Positioning and Comfort in Late Preterm Infants

An interventional study of Sequential post-care positioning in Premature Birth and Premature, sponsored by Saglik Bilimleri Universitesi. Completed at 1 site in Turkey (Türkiye). Per ClinicalTrials.gov, last updated 2026-10-19.

Sponsored by Saglik Bilimleri Universitesi · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Feb 2026, registered Oct 2026).
Updated Oct 19, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Premature Birth
  • Premature

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Keywords

  • patient positioning
  • late preterm infant
  • comfort
  • NICU
03

In context

Premature Birth

2,610 studies on the registry are indexed under Premature Birth; 507 are open to participants now.

This study's enrollment of 50 is below the median of 84 across 1,722 interventional studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

Saglik Bilimleri Universitesi is the lead sponsor of 447 studies on the registry; 138 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Congenital anomaly
  • Metabolic disease
  • Mechanical ventilation
  • Umbilical catheter
  • Medication other than vitamin and mineral supplements
  • Need for a painful procedure during the observation period
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Post-care positioning

    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.

    Other: Sequential post-care positioning

Interventions

  • OtherSequential post-care positioning

    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

06

What researchers measure

Primary outcomes

  1. 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.

    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

Secondary outcomes

  1. PICS dimension scores

    Scores of each of the seven PICS items (range 1-5; lower scores indicate greater comfort).

    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

  2. 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).

    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

07

Study locations

1 site
  • Gulhane Training and Research Hospital, Neonatal Intensive Care Unit, Ankara, Türkiye
    Ankara, Ankara 06010, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No — De-identified data may be made available by the corresponding author upon reasonable request.

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2026 to primary completion in May 2026, 3 months.

Of 753 non-industry interventional studies with no phase under Premature Birth, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's 3 months is below that.

Counting every sponsor, half of 775 studies reached it within 24 months; a quarter within 12 and three quarters within 47.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 3, 2026
First posted
Oct 19, 2026
StartActual
Feb 1, 2026
Primary completionActual
May 15, 2026
CompletionActual
May 30, 2026
Last update
Oct 19, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 19, 2026
Show all 1 update
  1. Oct 19, 2026
    First appeared on the registry

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 ↗

10

Registry details

Key details

Study ID
NCT07881653
Responsible party
Kardelen Köroğlu (Kardelen Köroğlu, RN, MSc, PhD Candidate, University of Health Sciences Türkiye, Gülhane Faculty of Nursing, Department of Pediatric Nursing, Saglik Bilimleri Universitesi) — Principal investigator
First posted
Oct 19, 2026
Start date
Feb 1, 2026
Primary completion
May 15, 2026
Completion
May 30, 2026
Last update
Oct 19, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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