PretermNCT05509621
The Effect of Positions on Physiological Parameters of Preterm Neonates Receiving Mechanical Ventilation
A study testing The Effect of Supine Position on Physiological Parameters in Mechanically Ventilated Preterm Newborns, The Effect of Prone Position on Physiological Parameters in Mechanically Ventilated Preterm Newborns and The Effect of left lateral Position on Physiological Parameters in Mechanically Ventilated Preterm Newborns in people with Preterm and Nursing Caries, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 28 to 36 weeksHealthy volunteers can take part
- Conditions the study is for
- Preterm, Nursing Caries
- What is being tested?
- The Effect of Supine Position on Physiological Parameters in Mechanically Ventilated Preterm Newborns, The Effect of Prone Position on Physiological Parameters in Mechanically Ventilated Preterm Newborns and The Effect of left lateral Position on Physiological Parameters in Mechanically Ventilated Preterm Newborns
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2022to 1 May 2023
- 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 28 to 36 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- A gestational age of 28-36 weeks ,
- Receiving mechanical ventilation (non-intubated),
- Volunteer consent of the parents of the preterm neonate to participate in the study.
Who cannot join
- Receiving mechanical ventilation and being intubated,
- Having any congenital and genetic disorders,
- Having a health problem that prevents positioning,
- Having a chest tube, umbilical catheter or PICC line,
- Receiving continuous sedative therapy, anticonvulsive therapy and cardiac drug therapy,
- Frequent changes in mechanical ventilator settings,
- A feeding frequency of more than three hours.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Preterm, Nursing Caries
- Being tested
- The Effect of Supine Position on Physiological Parameters in Mechanically Ventilated Preterm Newborns, The Effect of Prone Position on Physiological Parameters in Mechanically Ventilated Preterm Newborns, The Effect of left lateral Position on Physiological Parameters in Mechanically Ventilated Preterm Newborns, The Effect of right lateral Position on Physiological Parameters in Mechanically Ventilated Preterm Newborns, The Effect of Quarter prone Position on Physiological Parameters in Mechanically Ventilated Preterm Newborns
- Keywords
- preterm neonate, position, mechanical ventilation, physiological parameters, nursing caries
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Effect of Supine Position on Physiological Parameters in Mechanically Ventilated Preterm NewbornsOther
Preterm neonates who receive mechanical ventilation support and meet the study criteria will be provided with daily routine nursing care. Afterward, when it is time for positioning, the infant will be randomly placed in positions assigned according to the randomization. After positioning, data will not be collected for the first 30 minutes of each positioning in order to ensure the stability of the neonate. Starting from the 30th minute, the heart rate and oxygen saturation of the preterm neonate will be checked on the monitor at 15-minute intervals over the course of 90 minutes, and the respiratory rate will be counted and recorded for 1 minute by the researcher. For each position, the procedures will be repeated in the same way and the values will be recorded.
The Effect of Prone Position on Physiological Parameters in Mechanically Ventilated Preterm NewbornsOther
Preterm neonates who receive mechanical ventilation support and meet the study criteria will be provided with daily routine nursing care. Afterward, when it is time for positioning, the infant will be randomly placed in positions assigned according to the randomization. After positioning, data will not be collected for the first 30 minutes of each positioning in order to ensure the stability of the neonate. Starting from the 30th minute, the heart rate and oxygen saturation of the preterm neonate will be checked on the monitor at 15-minute intervals over the course of 90 minutes, and the respiratory rate will be counted and recorded for 1 minute by the researcher. For each position, the procedures will be repeated in the same way and the values will be recorded.
The Effect of left lateral Position on Physiological Parameters in Mechanically Ventilated Preterm NewbornsOther
Preterm neonates who receive mechanical ventilation support and meet the study criteria will be provided with daily routine nursing care. Afterward, when it is time for positioning, the infant will be randomly placed in positions assigned according to the randomization. After positioning, data will not be collected for the first 30 minutes of each positioning in order to ensure the stability of the neonate. Starting from the 30th minute, the heart rate and oxygen saturation of the preterm neonate will be checked on the monitor at 15-minute intervals over the course of 90 minutes, and the respiratory rate will be counted and recorded for 1 minute by the researcher. For each position, the procedures will be repeated in the same way and the values will be recorded.
The Effect of right lateral Position on Physiological Parameters in Mechanically Ventilated Preterm NewbornsOther
Preterm neonates who receive mechanical ventilation support and meet the study criteria will be provided with daily routine nursing care. Afterward, when it is time for positioning, the infant will be randomly placed in positions assigned according to the randomization. After positioning, data will not be collected for the first 30 minutes of each positioning in order to ensure the stability of the neonate. Starting from the 30th minute, the heart rate and oxygen saturation of the preterm neonate will be checked on the monitor at 15-minute intervals over the course of 90 minutes, and the respiratory rate will be counted and recorded for 1 minute by the researcher. For each position, the procedures will be repeated in the same way and the values will be recorded.
The Effect of Quarter prone Position on Physiological Parameters in Mechanically Ventilated Preterm NewbornsOther
Preterm neonates who receive mechanical ventilation support and meet the study criteria will be provided with daily routine nursing care. Afterward, when it is time for positioning, the infant will be randomly placed in positions assigned according to the randomization. After positioning, data will not be collected for the first 30 minutes of each positioning in order to ensure the stability of the neonate. Starting from the 30th minute, the heart rate and oxygen saturation of the preterm neonate will be checked on the monitor at 15-minute intervals over the course of 90 minutes, and the respiratory rate will be counted and recorded for 1 minute by the researcher. For each position, the procedures will be repeated in the same way and the values will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| Supine position | Experimental | 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). Receives: Other: The Effect of Supine Position on Physiological Parameters in Mechanically Ventilated Preterm Newborns |
| Prone position | Experimental | 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). Receives: Other: The Effect of Prone Position on Physiological Parameters in Mechanically Ventilated Preterm Newborns |
| Left lateral position | Experimental | 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). Receives: Other: The Effect of left lateral Position on Physiological Parameters in Mechanically Ventilated Preterm Newborns |
| Right lateral position | Experimental | 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). Receives: Other: The Effect of right lateral Position on Physiological Parameters in Mechanically Ventilated Preterm Newborns |
| Quarter prone position | Experimental | 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). Receives: Other: The Effect of Quarter prone Position on Physiological Parameters in Mechanically Ventilated Preterm Newborns |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate
Beats per minute will be obtained using an electrocardiographic bedside monitor. An electrocardiographic bedside monitor will be placed on each of the babies.
Measured: 1 year
Oxygen Saturation
Oxygen saturation (SpO2) will be obtained using an electrocardiographic bedside monitor. A separate electrocardiographic bedside monitor will be placed for each of the babies.
Measured: 1 year
Respiratory Rate
Respiratory rate will be counted and recorded for 1 minute by the researcher.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start1 Sep 2022
- Primary completion1 Dec 2022
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for PretermStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Crossover
- Model description
- Preterm neonates to be included in the study will be placed in 5 different positions using a crossover design.In order not to repeat the order of positions,5 groups will be created as follows:ABCDE;BCDEA;CDEAB;DEABC;EABCD.The number of the groups created for not repeating the order of positions will be determined using the lottery method;Group1=CDEAB;Group2=BCDEA;Group3=EABCD;Group4=DEABC;Group5=ABCDE.Then,which position corresponds to which letter will be determined using the lottery method;A=quarter prone position,B=prone position,C=supine position,D=left lateral position,E=right lateral position.Afterward,40 preterm neonates will be randomly assigned to 5 groups using the block randomization method in line with the sample calculation. The order of the positions for the preterm neonate will be determined according to the position order of the group including the preterm infant.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek Konukbay, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
- Investigators
- DİLEK KONUKBAY, Principal investigator, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05509621
- Sponsor's protocol ID
- SBU-KONUKBAY-001
- Status last verified
- Dec 2023
- First submitted
- 30 May 2022
- Last updated
- 28 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Montgomery K, Choy NL, Steele M, Hough J. The effectiveness of quarter turn from prone in maintaining respiratory function in premature infants. J Paediatr Child Health. 2014 Dec;50(12):972-7. doi: 10.1111/jpc.12689. Epub 2014 Jul 13.
PubMed 25039401Utario Y, Rustina Y, Waluyanti FT. The Quarter Prone Position Increases Oxygen Saturation in Premature Infants Using Continuous Positive Airway Pressure. Compr Child Adolesc Nurs. 2017;40(sup1):95-101. doi: 10.1080/24694193.2017.1386976.
PubMed 29166184Yin T, Yuh YS, Liaw JJ, Chen YY, Wang KW. Semi-Prone Position Can Influence Variability in Respiratory Rate of Premature Infants Using Nasal CPAP. J Pediatr Nurs. 2016 Mar-Apr;31(2):e167-74. doi: 10.1016/j.pedn.2015.10.014. Epub 2015 Nov 21.
PubMed 26614613Brunherotti MA, Martinez EZ, Martinez FE. Effect of body position on preterm newborns receiving continuous positive airway pressure. Acta Paediatr. 2014 Mar;103(3):e101-5. doi: 10.1111/apa.12504. Epub 2013 Dec 20.
PubMed 24354904Gouna G, Rakza T, Kuissi E, Pennaforte T, Mur S, Storme L. Positioning effects on lung function and breathing pattern in premature newborns. J Pediatr. 2013 Jun;162(6):1133-7, 1137.e1. doi: 10.1016/j.jpeds.2012.11.036. Epub 2013 Jan 11.
PubMed 23312684Cakici M, Mutlu B. Effect of Body Position on Cardiorespiratory Stabilization and Comfort in Preterm Infants on Continuous Positive Airway Pressure. J Pediatr Nurs. 2020 Sep-Oct;54:e1-e8. doi: 10.1016/j.pedn.2020.06.015. Epub 2020 Jul 15.
PubMed 32680615
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Positions on Physiological Parameters of Preterm Neonates Receiving Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT05509621
- Acronym / sponsor ID
- SBU-KONUKBAY-001
- Conditions
- Preterm, Nursing Caries
- Keywords
- preterm neonate, position, mechanical ventilation, physiological parameters, nursing caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip FakultesiUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 22 Aug 2022 (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 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Preterm neonates to be included in the study will be placed in 5 different positions using a crossover design.In order not to repeat the order of positions,5 groups will be created as follows:ABCDE;BCDEA;CDEAB;DEABC;EABCD.The number of the groups created for not repeating the order of positions will be determined using the lottery method;Group1=CDEAB;Group2=BCDEA;Group3=EABCD;Group4=DEABC;Group5=ABCDE.Then,which position corresponds to which letter will be determined using the lottery method;A=quarter prone position,B=prone position,C=supine position,D=left lateral position,E=right lateral position.Afterward,40 preterm neonates will be randomly assigned to 5 groups using the block randomization method in line with the sample calculation. The order of the positions for the preterm neonate will be determined according to the position order of the group including the preterm infant.
| Arm | Type | Receives |
|---|---|---|
| Supine position | Experimental | Other: The Effect of Supine Position on Physiological Parameters in Mechanically Ventilated Preterm NewbornsTo 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). |
| Prone position | Experimental | Other: The Effect of Prone Position on Physiological Parameters in Mechanically Ventilated Preterm NewbornsTo 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). |
| Left lateral position | Experimental | Other: The Effect of left lateral Position on Physiological Parameters in Mechanically Ventilated Preterm NewbornsTo 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). |
| Right lateral position | Experimental | Other: The Effect of right lateral Position on Physiological Parameters in Mechanically Ventilated Preterm NewbornsTo 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). |
| Quarter prone position | Experimental | Other: The Effect of Quarter prone Position on Physiological Parameters in Mechanically Ventilated Preterm NewbornsTo 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). |
Who may qualify
- Ages
- 28 to 36 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- A gestational age of 28-36 weeks ,
- Receiving mechanical ventilation (non-intubated),
- Volunteer consent of the parents of the preterm neonate to participate in the study.
Key exclusion criteria (7 listed)
- Receiving mechanical ventilation and being intubated,
- Having any congenital and genetic disorders,
- Having a health problem that prevents positioning,
- Having a chest tube, umbilical catheter or PICC line,
- Receiving continuous sedative therapy, anticonvulsive therapy and cardiac drug therapy,
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 |
|---|---|---|
| The Effect of Supine Position on Physiological Parameters in Mechanically Ventilated Preterm NewbornsPreterm neonates who receive mechanical ventilation support and meet the study criteria will be provided with daily routine nursing care. Afterward, when it is time for positioning, the infant will be randomly placed in positions assigned according to the randomization. After positioning, data will not be collected for the first 30 minutes of each positioning in order to ensure the stability of the neonate. Starting from the 30th minute, the heart rate and oxygen saturation of the preterm neonate will be checked on the monitor at 15-minute intervals over the course of 90 minutes, and the respiratory rate will be counted and recorded for 1 minute by the researcher. For each position, the procedures will be repeated in the same way and the values will be recorded. | Other | Supine position |
| The Effect of Prone Position on Physiological Parameters in Mechanically Ventilated Preterm NewbornsPreterm neonates who receive mechanical ventilation support and meet the study criteria will be provided with daily routine nursing care. Afterward, when it is time for positioning, the infant will be randomly placed in positions assigned according to the randomization. After positioning, data will not be collected for the first 30 minutes of each positioning in order to ensure the stability of the neonate. Starting from the 30th minute, the heart rate and oxygen saturation of the preterm neonate will be checked on the monitor at 15-minute intervals over the course of 90 minutes, and the respiratory rate will be counted and recorded for 1 minute by the researcher. For each position, the procedures will be repeated in the same way and the values will be recorded. | Other | Prone position |
| The Effect of left lateral Position on Physiological Parameters in Mechanically Ventilated Preterm NewbornsPreterm neonates who receive mechanical ventilation support and meet the study criteria will be provided with daily routine nursing care. Afterward, when it is time for positioning, the infant will be randomly placed in positions assigned according to the randomization. After positioning, data will not be collected for the first 30 minutes of each positioning in order to ensure the stability of the neonate. Starting from the 30th minute, the heart rate and oxygen saturation of the preterm neonate will be checked on the monitor at 15-minute intervals over the course of 90 minutes, and the respiratory rate will be counted and recorded for 1 minute by the researcher. For each position, the procedures will be repeated in the same way and the values will be recorded. | Other | Left lateral position |
| The Effect of right lateral Position on Physiological Parameters in Mechanically Ventilated Preterm NewbornsPreterm neonates who receive mechanical ventilation support and meet the study criteria will be provided with daily routine nursing care. Afterward, when it is time for positioning, the infant will be randomly placed in positions assigned according to the randomization. After positioning, data will not be collected for the first 30 minutes of each positioning in order to ensure the stability of the neonate. Starting from the 30th minute, the heart rate and oxygen saturation of the preterm neonate will be checked on the monitor at 15-minute intervals over the course of 90 minutes, and the respiratory rate will be counted and recorded for 1 minute by the researcher. For each position, the procedures will be repeated in the same way and the values will be recorded. | Other | Right lateral position |
| The Effect of Quarter prone Position on Physiological Parameters in Mechanically Ventilated Preterm NewbornsPreterm neonates who receive mechanical ventilation support and meet the study criteria will be provided with daily routine nursing care. Afterward, when it is time for positioning, the infant will be randomly placed in positions assigned according to the randomization. After positioning, data will not be collected for the first 30 minutes of each positioning in order to ensure the stability of the neonate. Starting from the 30th minute, the heart rate and oxygen saturation of the preterm neonate will be checked on the monitor at 15-minute intervals over the course of 90 minutes, and the respiratory rate will be counted and recorded for 1 minute by the researcher. For each position, the procedures will be repeated in the same way and the values will be recorded. | Other | Quarter prone position |
Primary outcome
Heart Rate
Time frame: 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
Time frame: 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.
Respiratory Rate
Time frame: 1 year
Respiratory rate will be counted and recorded for 1 minute by the researcher.
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 28 Dec 2023.
- Results publication: PubMed 25039401Montgomery K, Choy NL, Steele M, Hough J. The effectiveness of quarter turn from prone in maintaining respiratory function in premature infants. J Paediatr Child Health. 2014 Dec;50(12):972-7. doi: 10.1111/jpc.12689. Epub 2014 Jul 13.
- Results publication: PubMed 29166184Utario Y, Rustina Y, Waluyanti FT. The Quarter Prone Position Increases Oxygen Saturation in Premature Infants Using Continuous Positive Airway Pressure. Compr Child Adolesc Nurs. 2017;40(sup1):95-101. doi: 10.1080/24694193.2017.1386976.
- Results publication: PubMed 26614613Yin T, Yuh YS, Liaw JJ, Chen YY, Wang KW. Semi-Prone Position Can Influence Variability in Respiratory Rate of Premature Infants Using Nasal CPAP. J Pediatr Nurs. 2016 Mar-Apr;31(2):e167-74. doi: 10.1016/j.pedn.2015.10.014. Epub 2015 Nov 21.
- Results publication: PubMed 24354904Brunherotti MA, Martinez EZ, Martinez FE. Effect of body position on preterm newborns receiving continuous positive airway pressure. Acta Paediatr. 2014 Mar;103(3):e101-5. doi: 10.1111/apa.12504. Epub 2013 Dec 20.
- Results publication: PubMed 23312684Gouna G, Rakza T, Kuissi E, Pennaforte T, Mur S, Storme L. Positioning effects on lung function and breathing pattern in premature newborns. J Pediatr. 2013 Jun;162(6):1133-7, 1137.e1. doi: 10.1016/j.jpeds.2012.11.036. Epub 2013 Jan 11.
- Results publication: PubMed 32680615Cakici M, Mutlu B. Effect of Body Position on Cardiorespiratory Stabilization and Comfort in Preterm Infants on Continuous Positive Airway Pressure. J Pediatr Nurs. 2020 Sep-Oct;54:e1-e8. doi: 10.1016/j.pedn.2020.06.015. Epub 2020 Jul 15.
- Individual participant dataSharing planned: No
Related trials for Preterm
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
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.
DİLEK KONUKBAY principal investigator
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Effect of Supine Position on Physiological Parameters in Mechanically Ventilated Preterm Newborns, The Effect of Prone Position on Physiological Parameters in Mechanically Ventilated Preterm Newborns and The Effect of left lateral Position on Physiological Parameters in Mechanically Ventilated Preterm Newborns in people with Preterm and Nursing Caries, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi 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 3 inclusion and 7 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 28 Dec 2023. 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?
Heart Rate (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05509621, which also lists 6 linked publications.
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 28 Dec 2023.