Prone and Supine Positions in Preterm Infants Receiving Mechanical Ventilation
Primary Purpose
Preterm Infant, Ventilator Lung; Newborn, Preterm Birth
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Group 1:Supine-Prone
Group 2:Prone-Supine
Sponsored by
About this trial
This is an interventional supportive care trial for Preterm Infant focused on measuring Preterm infant, Mechanical ventilation, Position
Eligibility Criteria
Inclusion Criteria:
- 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,
Exclusion Criteria:
- Neuromuscular disease,
- Pulmonary arterial hypertension,
- Emphysema,
- Active bleeding,
- Respiratory problem due to heart disease,
- Obstacle to give birth position congenital disorder,
- 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.
Sites / Locations
- Health Sciences University Education and Research Hospital, Neonatal Intensive Care Unit
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group 1:First supine position,then prone position
Group 2:First prone position, then supine position
Arm Description
First group was supine position then prone position.
Second group was first prone position, then supine position.
Outcomes
Primary Outcome Measures
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.
Oxygen Saturation
Oxygen saturation (SpO2) was obtained using a pulse oximetry device. A separate pulse oximetry probe was inserted into each of the infants.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03895242
Brief Title
Prone and Supine Positions in Preterm Infants Receiving Mechanical Ventilation
Official Title
The Effect on Physiological Variables of Prone and Supine Positions Given to Preterm Infants Receiving Mechanical Ventilation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
February 2015 (Actual)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Akdeniz University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Infant, Ventilator Lung; Newborn, Preterm Birth
Keywords
Preterm infant, Mechanical ventilation, Position
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1:First supine position,then prone position
Arm Type
Experimental
Arm Description
First group was supine position then prone position.
Arm Title
Group 2:First prone position, then supine position
Arm Type
Experimental
Arm Description
Second group was first prone position, then supine position.
Intervention Type
Behavioral
Intervention Name(s)
Group 1:Supine-Prone
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Group 2:Prone-Supine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Heart Rate
Description
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.
Time Frame
An average of 2 year
Title
Oxygen Saturation
Description
Oxygen saturation (SpO2) was obtained using a pulse oximetry device. A separate pulse oximetry probe was inserted into each of the infants.
Time Frame
An average of 2 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
7 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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,
Exclusion Criteria:
Neuromuscular disease,
Pulmonary arterial hypertension,
Emphysema,
Active bleeding,
Respiratory problem due to heart disease,
Obstacle to give birth position congenital disorder,
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emine EFE
Organizational Affiliation
Akdeniz University Children's Health and the Nursing Department
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sultan Beşiktaş
Organizational Affiliation
Antalya Health Sciences University Education and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health Sciences University Education and Research Hospital, Neonatal Intensive Care Unit
City
Antalya
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22049286
Citation
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.
Results Reference
background
PubMed Identifier
11805748
Citation
Chang 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.
Results Reference
background
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Prone and Supine Positions in Preterm Infants Receiving Mechanical Ventilation
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