The Effect of Positions on Physiological Parameters of Preterm Neonates Receiving Mechanical Ventilation

Not Applicable

Completed

• Conditions: Nursing Caries; Preterm
• Interventions: Other: The Effect of Supine Position on Physiological Parameters in Mechanically Ventilated Preterm Newborns; Other: The Effect of right lateral Position on Physiological Parameters in Mechanically Ventilated Preterm Newborns; Other: The Effect of Prone Position on Physiological Parameters in Mechanically Ventilated Preterm Newborns; Other: The Effect of Quarter prone Position on Physiological Parameters in Mechanically Ventilated Preterm Newborns; Other: The Effect of left lateral Position on Physiological Parameters in Mechanically Ventilated Preterm Newborns

• Registration Number: NCT05509621
• Lead Sponsor: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Brief Summary

This study was planned as an experimental study with a randomized crossover design to determine the effect of supine, prone, right lateral, left lateral, and quarter prone positions used during daily routine care in the neonatal intensive care unit on physiological parameters (oxygen saturation, heart rate, respiratory rate) of preterm neonates receiving mechanical ventilation.

Detailed Description

Preterm neonates face various adaptation problems starting from their birth due to their underdeveloped organ systems. A significant portion of preterm neonates need advanced care due to respiratory system problems, especially due to insufficient adaptation of the respiratory systems to the extrauterine environment, and the majority of them require mechanical ventilation. For these reasons, it is a priority to restore the respiratory functions of preterm neonates. To ensure the functionality of body systems in the developmental care of neonates in this process, the method of neonatal positioning, which is one of the individualized supportive developmental care methods, is necessary. The primary goal of positioning in neonatal intensive care units is to reduce the effects of pain and environmental stimuli caused by interventions for treatment and care for neonates and to help them cope with stress by maintaining their posture. Developmental positioning practices aim to support neuromotor development and minimize pain by maintaining the comfortable position of the neonate surrounded by the midline. The positioning has been shown to significantly affect the respiratory systems of neonates and affect oxygenation and lung ventilation. Change of position is also crucial in physiological and neurodevelopmental aspects for neonates receiving mechanical ventilation. It is important to reposition neonates since they remain in the same position all the time, which may lead to the accumulation of secretions and the formation of pressure sores. Positioning is an important factor in the development of neonates; therefore, correct positioning is critical for the comfort of neonates in the short and long term. Giving and maintaining a suitable position for neonates is an important nursing intervention. With developmentally supportive positioning applications, infants are positioned in supine, prone, lateral (right/left) and quarter prone positions. Considering these positions one by one, the supine position, where nursing care can be provided more easily, increases the sensory-motor activities of the neonate and reduces the energy consumption resulting from the infant's activities. Neonatal intensive care units mostly place neonates in the prone position since it has a positive effect on breathing, sleep quality, and behavioral conditions. The prone position makes the newborn feel safer with the adjustments made in the extrauterine environment. The lateral (right/left) position is one of the positions reducing the extensor effects of gravity and supporting the midline orientation of the hands and feet along with the head, which can be preferred in cases where the prone position cannot be used. In the quarter-prone position, neonates are placed in a functional position similar to the prone position but with one side of the body slightly elevated to encourage the synchronous movement of the thoracic and abdominal respiratory muscles. It has been observed that the quarter prone position provides similar advantages as the prone position by increasing lung compliance, tidal volume, respiratory rhythm, and oxygenation during sleep. Preterm neonates are placed in these positions in daily routine care of neonatal intensive care units.

The review of the relevant literature reveals studies comparing different groups regarding the positioning of preterm neonates receiving mechanical ventilators in the neonatal intensive care unit. These studies have mainly focused on the effect of supine, prone, right lateral and left lateral positions in preterm neonates receiving mechanical ventilation.

There is no study collectively comparing supine, prone, right lateral, left lateral and quarter prone positions used during daily routine care of preterm neonates receiving mechanical ventilation, which was aimed in this study. In this context, it was considered that evaluating the effect of supine, prone, right lateral, left lateral and quarter prone positions routinely used in the neonatal intensive care unit on the physiological parameters of preterm neonates receiving mechanical ventilation (oxygen saturation, heart rate, respiratory rate) and determining which position is more effective for preterm infants will contribute to the literature and guide the care provided by neonatal nurses.

Place And Tıme Of The Study:

This study was planned to be conducted in the Neonatal Intensive Care Unit of the University of Health Sciences Etlik Zubeyde Hanim Gynecology Training and Research Hospital between June 2022 and June 2023 after obtaining the necessary institutional and ethical committee approvals.

Hypotheses Of The Study:

Hypothesis 0(H0): There is no difference between prone, supine, right lateral, left lateral and quarter prone positioning of preterm infants in terms of physiological parameters of the infant.

Hypothesis 1.1(H1.1): Supine positioning of preterm infants is more effective in physiological parameters than other positions.

Hypothesis 1.2(H1.2): Prone positioning of preterm infants is more effective in physiological parameters than other positions.

Hypothesis 1.3(H1.3): Left lateral positioning of preterm infants is more effective in physiological parameters than other positions.

Hypothesis 1.4(H1.4): Right lateral positioning of preterm infants is more effective in physiological parameters than other positions.

Hypothesis 1.5(H1.5): Quarter prone positioning of preterm infants is more effective in physiological parameters than other positions.

Unıverse And Sample Of The Study:

The universe of the study comprised preterm neonates receiving mechanical ventilation in the Neonatal Intensive Care Unit of the University of Health Sciences Etlik Zubeyde Hanim Gynecology Training and Research Hospital. Multi-group comparisons were planned in the analysis of the hypotheses of the study and the sample size calculated according to the statistical method to be used was taken as a basis.

Using "G."Power version 3.1.9.2" software, the sample size was calculated at a confidence level of 95%. As a result of the analysis, α=0.05, the standardized effect size was calculated from a similar study conducted in this field. The minimum sample size was estimated as 8 subjects for each group when the effect size was taken as 0.72 (high), with theoretical power of 0.80. As evaluations will be carried out in 5 groups in this study, the minimum sample size was found to be 40.

Study Timeline

• Study First Submitted: 2022-05-30
• Study First Submitted QC: 2022-08-18
• Study First Posted: 2022-08-22
• Study Start: 2022-09-01
• Primary Completion: 2022-12-01
• Study Completion: 2023-05-01
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-27
• Last Update Posted: 2023-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Supine position	The Effect of Supine Position on Physiological Parameters in Mechanically Ventilated Preterm Newborns	To determine the effect of supine position used during daily routine care in the neonatal intensive care unit on physiological parameters (oxygen saturation, heart rate, respiratory rate).
Right lateral position	The Effect of right lateral Position on Physiological Parameters in Mechanically Ventilated Preterm Newborns	To determine the effect of right lateral position used during daily routine care in the neonatal intensive care unit on physiological parameters (oxygen saturation, heart rate, respiratory rate).
Prone position	The Effect of Prone Position on Physiological Parameters in Mechanically Ventilated Preterm Newborns	To determine the effect of prone position used during daily routine care in the neonatal intensive care unit on physiological parameters (oxygen saturation, heart rate, respiratory rate).
Quarter prone position	The Effect of Quarter prone Position on Physiological Parameters in Mechanically Ventilated Preterm Newborns	To determine the effect of quarter prone position used during daily routine care in the neonatal intensive care unit on physiological parameters (oxygen saturation, heart rate, respiratory rate).
Left lateral position	The Effect of left lateral Position on Physiological Parameters in Mechanically Ventilated Preterm Newborns	To determine the effect of left lateral position used during daily routine care in the neonatal intensive care unit on physiological parameters (oxygen saturation, heart rate, respiratory rate).

Primary Outcome Measures

Name	Time	Method
Respiratory Rate	1 year	Respiratory rate will be counted and recorded for 1 minute by the researcher.
Heart Rate	1 year	Beats per minute will be obtained using an electrocardiographic bedside monitor. An electrocardiographic bedside monitor will be placed on each of the babies.
Oxygen Saturation	1 year	Oxygen saturation (SpO2) will be obtained using an electrocardiographic bedside monitor. A separate electrocardiographic bedside monitor will be placed for each of the babies.

Trial Locations

Locations (1)

University of Health Sciences Turkey; 🇹🇷 Ankara, Turkey