Preterm InfantNCT03895242
Prone and Supine Positions in Preterm Infants Receiving Mechanical Ventilation
A study testing Group 1:Supine-Prone and Group 2:Prone-Supine in people with Preterm Infant and Ventilator Lung; Newborn, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
Positioning, which is one of the individualized developmental care methods, is known as the important care support process which is applied with the purpose of ensuring the least damage from the environmental. Positioning in preterm infants is the basis of neonatal nursing care. Read more about this study
- Who is it for?
- Ages 1 day to 7 days
- Conditions the study is for
- Preterm Infant, Ventilator Lung; Newborn, Preterm Birth
- What is being tested?
- Group 1:Supine-Prone and Group 2:Prone-Supine
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2015to Jun 2016
- 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 1 day to 7 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestation week from 25 to 36 weeks
- Spontaneous breathing with mechanical ventilation (required ventilatory support and at least 12 hours in nasal continuous positive airway pressure therapy),
- Postnatal age ≤ 7 days,
Who cannot join
- Neuromuscular disease,
- Pulmonary arterial hypertension,
- Emphysema,
- Active bleeding,
- Respiratory problem due to heart disease,
- Obstacle to give birth position congenital disorder,
Show all 13Show fewer
- Abdominal or thoracic surgery,
- Hypothermia and hyperthermia,
- Chest with tube,
- Continuous sedative treatment,
- Anticonvulsive therapy and cardiac drug therapy,
- Mechanical ventilator settings vary frequently,
- Preterm neonates with a frequency of more than three hours were not included in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Health Sciences University Education and Research Hospital, Neonatal Intensive Care Unit
Antalya
About this study
Official title: The Effect on Physiological Variables of Prone and Supine Positions Given to Preterm Infants Receiving Mechanical Ventilation
Positioning, which is one of the individualized developmental care methods, is known as the important care support process which is applied with the purpose of ensuring the least damage from the environmental. Positioning in preterm infants is the basis of neonatal nursing care. Positioning in preterm infants receiving mechanical ventilation support is important in terms of physiological and neurodevelopment. In infants undergoing respiratory support in NICU, it is important to determine the appropriate position, the frequency and duration of position change in order to reduce the oxygen need. In this respect, the aim of this study, designed as a randomized controlled trial, was to determine the effect of supine and prone positions on physiological variables (oxygen saturation and heart rate) of preterm infants receiving mechanical ventilation.
Read the detailed description
In infants undergoing respiratory support in NICU, it is important to determine the appropriate position, the frequency and duration of position change in order to reduce the oxygen need. Therefore, the aim of this randomized controlled study, test the efficacy of two different positions (prone-supine) given to preterm newborns receiving mechanical ventilation.The study was conducted from February 2015 to June 2016.
Participants and setting:
We were interested in establishing the difference between the supine position and the prone position, with an error margin of 10%. According to the formula of the calculated sample size, for a crossover design with a = 0.05, the sample size required to achieve a 90% power is 36 infants. Thirty-eight infants who met the inclusion criteria of the study were selected and invited to participate. Of these, parents of 38 infants consented. A convenience sample of hospitalized preterm infants (less than 37 weeks gestational age) was selected from a tertiary neonatal intensive care unit of a teaching and research hospital in Turkey. Preterm infants were divided into two groups by randomization according to position priority (n = 38). First group was first supine position followed by prone position (n = 19), second group was first prone position, then supine position (n = 19). The priority of the positions to be given to preterm infants was randomly determined using the closed envelope method. The positions of infants were written in envelopes and closed. The clinical nurse, who was not in the research, pulled the envelope and identified position group of the infant . Thus, data were collected for both the prone and the supine position from a newborn.
Procedure and data collection:
The infants involved in the study were cared for in a incubator and wore diapers only. The temperature of the incubator was set to maintain a body temperature ranging from 36.5 to 37.2 °C. After necessary routine procedures such as diapering, body cleaning, weighing and suctioning were completed, each subject was randomly assigned to the supine-prone group or prone-supine group sequence. All of the positions of preterm infants were given carefully by the researcher.
Data Collection Tools:
Infant descriptive characteristics form: The form was developed in light of the relevant literature to collect data about gender, age, gestational age, body weight at study.
Infant's clinical variables form. The form was developed by the researchers according to the literature to collect data such as infant feeding method, caffeine and surfactant treatment.
Physiological variable monitoring form: The form was developed to record heart rate (HR) (min) and oxygen saturation (% SpO2) values in the literature.
Pulse Oximeter Device: A pulse oximetry was used to determine HR and SpO2. The physiological parameters were measured and recorded every 15 minute for a total of 120 minute. The normal vital sign ranges assumed for the study subjects were as follows; heart rate range of 121 to 179 beats per minute, oxygen saturation range ≥92%. The pulse oximetry was calibrated as recommended by the manufacturer prior to use at the beginning of each shift within the study period. The pulse oximetry probe was attached to the foot of the leg.All of the measurements were performed by researcher who carefully and prudently recorded the infants' response throughout the study process.
Positioning material:
Rolled sheets were used when infants were given positions.
Statistical analysis:
Data were analyzed using SPSS version 22.0 (SPSS Inc., Chicago, IL, USA) statistical program. Descriptive statistics were reported using frequencies, percentages, mean values, standard deviation, and range. The Kolmogorov-Smirnov test was conducted to assess the distribution of the variables in order to use a parametric or non-parametric test. All the variables were normally distributed. Therefore, parametric tests such as analysis of variance and t-test were used to determine the differences in variables between groups. Variance analysis was used for repeated measurements of heart rates and oxygen saturation measured by infants at 15 min intervals. A value of p <0.05 was considered statistically significant.
Ethical considerations:
İn the study, written consent was obtained from the ethics committee, institutions and families.
- Conditions
- Preterm Infant, Ventilator Lung; Newborn, Preterm Birth
- Being tested
- Group 1:Supine-Prone, Group 2:Prone-Supine
- Keywords
- Preterm infant, Mechanical ventilation, Position
- Medical subject headings
- Premature Birth, Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1:Supine-ProneBehavioural
After the infants were treated and fed, supine position was first given and waited for 60 minutes to stabilise (no data was collected during this time). After 61 minutes, it was allowed to stay in supine position for 2 hours. From the 61st minute, heart rate and oxygen saturation were evaluated in each infant in the supine positions at intervals of 15 min over a period of 120 min. At the end of two hours, the infant was given the prone position after the routine requirements such as diaper replacement were completed. Infants were waiting for 60 minutes to stabilize after the prone position (no data was collected during this time). From the 61st minute, heart rate and oxygen saturation were evaluated in each infant in the prone positions at intervals of 15 min over a period of 120 min.
Group 2:Prone-SupineBehavioural
After the infants were treated and fed, prone position was first given and waited for 60 minutes to stabilise (no data was collected during this time). After 61 minutes, it was allowed to stay in prone position for 2 hours. From the 61st minute, heart rate and oxygen saturation were evaluated in each infant in the prone positions at intervals of 15 min over a period of 120 min. At the end of two hours, the infant was given the supine position after the routine requirements such as diaper replacement were completed. Infants were waiting for 60 minutes to stabilize after the supine position (no data was collected during this time). From the 61st minute, heart rate and oxygen saturation were evaluated in each infant in the prone positions at intervals of 15 min over a period of 120 min.
| Study group | Role | What they receive |
|---|---|---|
| Group 1:First supine position,then prone position | Experimental | First group was supine position then prone position. Receives: Behavioral: Group 1:Supine-Prone |
| Group 2:First prone position, then supine position | Experimental | Second group was first prone position, then supine position. Receives: Behavioral: Group 2:Prone-Supine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate
The number of heartbeats per minute was obtained using a pulse oximetry device. A separate pulse oximetry probe was inserted into each of the infants.
Measured: An average of 2 year
Oxygen Saturation
Oxygen saturation (SpO2) was obtained using a pulse oximetry device. A separate pulse oximetry probe was inserted into each of the infants.
Measured: An average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2019
- Study startFeb 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Preterm InfantStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- 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
- The priority of the positions to be given to preterm infants was randomly determined.The positions of preterm infants was identified using the closed envelope method.The positions of infants were written in envelopes and closed.The clinical nurse, who was not in the research, pulled the envelope and identified the infant position.First group was first supine position,then prone position (n = 19), second group was first prone position, then supine position (n = 19).
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sultan Besiktas, Akdeniz University
- Investigators
- Emine EFE, Study director, Akdeniz University Children's Health and the Nursing DepartmentSultan Beşiktaş, Principal investigator, Antalya Health Sciences University Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03895242
- Sponsor's protocol ID
- AkdenizU
- Status last verified
- Mar 2019
- First submitted
- 24 Mar 2019
- Last updated
- 29 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abdeyazdan Z, Nematollahi M, Ghazavi Z, Mohhamadizadeh M. The effects of supine and prone positions on oxygenation in premature infants undergoing mechanical ventilation. Iran J Nurs Midwifery Res. 2010 Fall;15(4):229-33.
PubMed 22049286Chang YJ, Anderson GC, Dowling D, Lin CH. Decreased activity and oxygen desaturation in prone ventilated preterm infants during the first postnatal week. Heart Lung. 2002 Jan-Feb;31(1):34-42. doi: 10.1067/mhl.2002.120241.
PubMed 11805748
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect on Physiological Variables of Prone and Supine Positions Given to Preterm Infants Receiving Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT03895242
- Acronym / sponsor ID
- AkdenizU
- Conditions
- Preterm Infant, Ventilator Lung; Newborn, Preterm Birth
- Keywords
- Preterm infant, Mechanical ventilation, Position
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- Feb 2015 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 29 Mar 2019 (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.
Positioning, which is one of the individualized developmental care methods, is known as the important care support process which is applied with the purpose of ensuring the least damage from the environmental. Positioning in preterm infants is the basis of neonatal nursing care. Positioning in preterm infants receiving mechanical ventilation support is important in terms of physiological and neurodevelopment. In infants undergoing respiratory support in NICU, it is important to determine the appropriate position, the frequency and duration of position change in order to reduce the oxygen need. In this respect, the aim of this study, designed as a randomized controlled trial, was to determine the effect of supine and prone positions on physiological variables (oxygen saturation and heart rate) of preterm infants receiving mechanical ventilation.
Detailed description
In infants undergoing respiratory support in NICU, it is important to determine the appropriate position, the frequency and duration of position change in order to reduce the oxygen need. Therefore, the aim of this randomized controlled study, test the efficacy of two different positions (prone-supine) given to preterm newborns receiving mechanical ventilation.The study was conducted from February 2015 to June 2016.
Participants and setting:
We were interested in establishing the difference between the supine position and the prone position, with an error margin of 10%. According to the formula of the calculated sample size, for a crossover design with a = 0.05, the sample size required to achieve a 90% power is 36 infants. Thirty-eight infants who met the inclusion criteria of the study were selected and invited to participate. Of these, parents of 38 infants consented. A convenience sample of hospitalized preterm infants (less than 37 weeks gestational age) was selected from a tertiary neonatal intensive care unit of a teaching and research hospital in Turkey. Preterm infants were divided into two groups by randomization according to position priority (n = 38). First group was first supine position followed by prone position (n = 19), second group was first prone position, then supine position (n = 19). The priority of the positions to be given to preterm infants was randomly determined using the closed envelope method. The positions of infants were written in envelopes and closed. The clinical nurse, who was not in the research, pulled the envelope and identified position group of the infant . Thus, data were collected for both the prone and the supine position from a newborn.
Procedure and data collection:
The infants involved in the study were cared for in a incubator and wore diapers only. The temperature of the incubator was set to maintain a body temperature ranging from 36.5 to 37.2 °C. After necessary routine procedures such as diapering, body cleaning, weighing and suctioning were completed, each subject was randomly assigned to the supine-prone group or prone-supine group sequence. All of the positions of preterm infants were given carefully by the researcher.
Data Collection Tools:
Infant descriptive characteristics form: The form was developed in light of the relevant literature to collect data about gender, age, gestational age, body weight at study.
Infant's clinical variables form. The form was developed by the researchers according to the literature to collect data such as infant feeding method, caffeine and surfactant treatment.
Physiological variable monitoring form: The form was developed to record heart rate (HR) (min) and oxygen saturation (% SpO2) values in the literature.
Pulse Oximeter Device: A pulse oximetry was used to determine HR and SpO2. The physiological parameters were measured and recorded every 15 minute for a total of 120 minute. The normal vital sign ranges assumed for the study subjects were as follows; heart rate range of 121 to 179 beats per minute, oxygen saturation range ≥92%. The pulse oximetry was calibrated as recommended by the manufacturer prior to use at the beginning of each shift within the study period. The pulse oximetry probe was attached to the foot of the leg.All of the measurements were performed by researcher who carefully and prudently recorded the infants' response throughout the study process.
Positioning material:
Rolled sheets were used when infants were given positions.
Statistical analysis:
Data were analyzed using SPSS version 22.0 (SPSS Inc., Chicago, IL, USA) statistical program. Descriptive statistics were reported using frequencies, percentages, mean values, standard deviation, and range. The Kolmogorov-Smirnov test was conducted to assess the distribution of the variables in order to use a parametric or non-parametric test. All the variables were normally distributed. Therefore, parametric tests such as analysis of variance and t-test were used to determine the differences in variables between groups. Variance analysis was used for repeated measurements of heart rates and oxygen saturation measured by infants at 15 min intervals. A value of p <0.05 was considered statistically significant.
Ethical considerations:
İn the study, written consent was obtained from the ethics committee, institutions and families.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The priority of the positions to be given to preterm infants was randomly determined.The positions of preterm infants was identified using the closed envelope method.The positions of infants were written in envelopes and closed.The clinical nurse, who was not in the research, pulled the envelope and identified the infant position.First group was first supine position,then prone position (n = 19), second group was first prone position, then supine position (n = 19).
| Arm | Type | Receives |
|---|---|---|
| Group 1:First supine position,then prone position | Experimental | Behavioral: Group 1:Supine-ProneFirst group was supine position then prone position. |
| Group 2:First prone position, then supine position | Experimental | Behavioral: Group 2:Prone-SupineSecond group was first prone position, then supine position. |
Who may qualify
- Ages
- 1 day to 7 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Gestation week from 25 to 36 weeks
- Spontaneous breathing with mechanical ventilation (required ventilatory support and at least 12 hours in nasal continuous positive airway pressure therapy),
- Postnatal age ≤ 7 days,
Key exclusion criteria (13 listed)
- Neuromuscular disease,
- Pulmonary arterial hypertension,
- Emphysema,
- Active bleeding,
- Respiratory problem due to heart disease,
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 |
|---|---|---|
| Group 1:Supine-ProneAfter the infants were treated and fed, supine position was first given and waited for 60 minutes to stabilise (no data was collected during this time). After 61 minutes, it was allowed to stay in supine position for 2 hours. From the 61st minute, heart rate and oxygen saturation were evaluated in each infant in the supine positions at intervals of 15 min over a period of 120 min. At the end of two hours, the infant was given the prone position after the routine requirements such as diaper replacement were completed. Infants were waiting for 60 minutes to stabilize after the prone position (no data was collected during this time). From the 61st minute, heart rate and oxygen saturation were evaluated in each infant in the prone positions at intervals of 15 min over a period of 120 min. | Behavioural | Group 1:First supine position,then prone position |
| Group 2:Prone-SupineAfter the infants were treated and fed, prone position was first given and waited for 60 minutes to stabilise (no data was collected during this time). After 61 minutes, it was allowed to stay in prone position for 2 hours. From the 61st minute, heart rate and oxygen saturation were evaluated in each infant in the prone positions at intervals of 15 min over a period of 120 min. At the end of two hours, the infant was given the supine position after the routine requirements such as diaper replacement were completed. Infants were waiting for 60 minutes to stabilize after the supine position (no data was collected during this time). From the 61st minute, heart rate and oxygen saturation were evaluated in each infant in the prone positions at intervals of 15 min over a period of 120 min. | Behavioural | Group 2:First prone position, then supine position |
Primary outcome
Heart Rate
Time frame: An average of 2 year
The number of heartbeats per minute was obtained using a pulse oximetry device. A separate pulse oximetry probe was inserted into each of the infants.
Oxygen Saturation
Time frame: An average of 2 year
Oxygen saturation (SpO2) was obtained using a pulse oximetry device. A separate pulse oximetry probe was inserted into each of the infants.
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 29 Mar 2019.
- Background: PubMed 22049286Abdeyazdan Z, Nematollahi M, Ghazavi Z, Mohhamadizadeh M. The effects of supine and prone positions on oxygenation in premature infants undergoing mechanical ventilation. Iran J Nurs Midwifery Res. 2010 Fall;15(4):229-33.
- Background: PubMed 11805748Chang YJ, Anderson GC, Dowling D, Lin CH. Decreased activity and oxygen desaturation in prone ventilated preterm infants during the first postnatal week. Heart Lung. 2002 Jan-Feb;31(1):34-42. doi: 10.1067/mhl.2002.120241.
- Individual participant dataSharing planned: No
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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.
Emine EFE study director
Akdeniz University Children's Health and the Nursing Department
Sultan Beşiktaş principal investigator
Antalya Health Sciences University Education and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group 1:Supine-Prone and Group 2:Prone-Supine in people with Preterm Infant and Ventilator Lung; Newborn, run by Akdeniz University 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 13 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 29 Mar 2019. 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: An average of 2 year). The study lists 2 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 NCT03895242, which also lists 2 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 29 Mar 2019.