Elevated Midline Positioning During Diaper Change in Preterm Infants
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4+
SponsorAkdeniz University
About this trial
Diaper changing is one of the most frequent routine care procedures in the neonatal intensive care unit (NICU) and is known to cause physiological instability and behavioral stress responses in preterm infants. During a conventional diaper change the infant is often kept in a side-lying position with the head turned to one side, which may impair jugular venous drainage. In contrast, 30-degree head-of-bed elevation with the head kept in the midline has been shown to lower intracranial pressure and is a core component of intraventricular hemorrhage prevention care bundles. No randomized controlled trial has yet examined the effect of this position during diaper change.
The purpose of this randomized controlled trial is to determine whether 30-degree elevated midline positioning during a routine diaper change, compared with standard care (diaper change in a flat, side-lying position), reduces oxygen desaturation and bradycardia episodes, lowers pain/stress scores measured with the Neonatal Infant Pain Scale (NIPS), and shortens the time needed for heart rate and oxygen saturation to return to baseline in stable preterm infants born at 28-34 weeks of gestation.
Eighty infants (40 per group) in the level III NICU of Antalya City Hospital, Türkiye, will be randomly assigned to one of the two groups. Each infant will be evaluated during a single diaper change performed after 96 hours of postnatal age.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Born between 28 and 34 weeks of gestation
Hemodynamically stable (not requiring inotropic support)
Not receiving invasive mechanical ventilation (infants on room air, CPAP or high-flow nasal cannula may be included)
Continuous SpO2 and heart rate monitoring in place
Disqualifiers
Receiving invasive mechanical ventilation
Major congenital or chromosomal anomaly
Previously diagnosed grade III-IV intraventricular hemorrhage or other significant intracranial pathology
Hemodynamic instability requiring inotropic support
Trial design
Design model
Parallel
Treatments tested in this trial
30-Degree Elevated Midline Positioning
Other interventionNursing positioning intervention applied during a single routine diaper change: 30-degree head-of-bed elevation without hip flexion; head kept in the midline with bilateral rolled supports and a neutral neck position; diaper changed by the log-roll technique, turning head, trunk and pelvis as one unit by about 15-30 degrees to each side without lifting the legs by the ankles. Performed by a trained neonatal nurse with at least one year of NICU experience, assisted by a second nurse who keeps the head in the midline.
Standard Lateral Position Diaper Change
Other interventionRoutine diaper change performed according to the unit's current standard practice, with the infant in a side-lying (lateral) position on a flat bed (0 degrees). No additional positioning manoeuvres (midline positioning, head-of-bed elevation or log-roll technique) are applied.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Elevated Midline Position GroupExperimental treatment 2 interventions
Group B: Standard Care Group (Flat Lateral Position)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of Oxygen Desaturation Episodes
Number of episodes in which peripheral oxygen saturation (SpO2) falls below 85% for at least 10 seconds, measured with continuous pulse oximetry. Two episodes are counted separately only if SpO2 remains at or above 85% for at least 10 seconds between them.
Time frame
From the start of the diaper change to 5 minutes after its completion2
Number of Bradycardia Episodes
Number of episodes in which heart rate falls below 100 beats per minute for at least 10 seconds, measured with continuous cardiorespiratory monitoring. Two episodes are counted separately only if heart rate remains at or above 100 beats per minute for at least 10 seconds between them.
Time frame
From the start of the diaper change to 5 minutes after its completionSecondary outcomes
1
Pain/Stress Score Measured With the Neonatal Infant Pain Scale (NIPS)
Assessed by direct observation by an independent neonatal nurse who is not involved in the procedure and is not informed of group allocation. The NIPS evaluates six behavioral indicators (facial expression, cry, breathing pattern, arms, legs and state of arousal). Total score ranges from 0 to 7; higher scores indicate more severe pain/stress. At T1, the highest score observed during the diaper change is recorded.
Time frame
1 minute before the diaper change (T0, baseline), during the diaper change (T1), and 1 minute (T2) and 5 minutes (T3) after its completion2
Time to Recovery of Oxygen Saturation to Baseline
Time in seconds from completion of the diaper change until SpO2 returns to no more than 2 percentage points below the baseline (T0) value and remains there for at least 10 seconds. Infants within this range at completion are assigned 0 seconds; infants not recovered by 5 minutes are assigned 300 seconds (censored).
Time frame
From completion of the diaper change up to 5 minutes after the procedure3
Time to Recovery of Heart Rate to Baseline
Time in seconds from completion of the diaper change until heart rate returns to within ±10 beats per minute of the baseline (T0) value and remains there for at least 10 seconds. Infants within this range at completion are assigned 0 seconds; infants not recovered by 5 minutes are assigned 300 seconds (censored).
Time frame
From completion of the diaper change up to 5 minutes after the procedure4
Heart Rate
Heart rate (beats per minute) recorded from the monitor; at T1 the value with the greatest deviation from baseline (increase or decrease) observed during the diaper change is recorded.
Time frame
1 minute before the diaper change (T0), during the diaper change (T1), and 1 minute (T2) and 5 minutes (T3) after its completionOther outcomes
1
Number of Infants With Adverse Events or Early Termination of the Procedure
Number of infants in whom the procedure was stopped because a stopping criterion was met (SpO2 \< 80% for more than 20 seconds, heart rate \< 80 beats per minute, apnea of 20 seconds or longer, or clinical judgment) or in whom an adverse event occurred, as recorded on the case report form and the follow-up form.
Time frame
From the start of the diaper change to 5 minutes after its completionLocations
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Source ClinicalTrials.gov
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