Effects of Therapeutic Positioning in Mechanically Ventilated Preterm Infants

NCT07845435 | Completed

• 1 other identifier: 15
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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, 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.

Conditions

Prematurity, Mechanical Ventilation

Keywords

Preterm Infant; Mechanical Ventilation; Therapeutic Positioning

Outcome Measures

Primary Outcomes (1)

• Pain Level Assessed Using the Premature Infant Pain Profile-Revised

  Pain Level Assessed Using the Premature Infant Pain Profile-Revised

  Baseline, 30 minutes, 2 hours, and 3 hours after positioning

Secondary Outcomes (1)

• Comfort Level Assessed Using the COMFORTneo Scale

  Baseline, 30 minutes, 2 hours, and 3 hours after positioning

Study Arms (3)

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.

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.

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.

Other: Supine Position

Interventions

Fetal Position OTHER

Standardized flexion-based positioning of the mechanically ventilated preterm infant using appropriate support materials to mimic the intrauterine posture for three hours.

Prone Position; Supine Position

Supine Position OTHER

Standardized placement of the mechanically ventilated preterm infant in the supine position for three hours.

Fetal Position; Prone Position

Prone Position OTHER

Standardized placement of the mechanically ventilated preterm infant in the prone position, with support of the trunk and pelvis, for three hours.

Supine Position

Eligibility Criteria

• Age: 35 Weeks - 37 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mustafa Kemal University: lead

Study Sites (1)

Çukurova Üniversitesi

Adana, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Supine Position; Prone Position

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Rana Rehap SERT

  Istanbul Sabahattin Zaim University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: September 22, 2026
• First Posted: September 28, 2026
• Study Start: February 7, 2024
• Primary Completion: February 7, 2025
• Study Completion: October 30, 2025
• Last Updated: September 28, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)