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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
What is being tested?
Group 1:Supine-Prone and Group 2:Prone-Supine
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

Other trials in Turkey (Türkiye)

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.

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 groups in NCT03895242
Study groupRoleWhat they receive
Group 1:First supine position,then prone positionExperimentalFirst group was supine position then prone position.
Receives: Behavioral: Group 1:Supine-Prone
Group 2:First prone position, then supine positionExperimentalSecond 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.

  1. 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

  2. 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.

  1. First posted29 Mar 2019
  2. Study startFeb 2015
  3. Primary completionJun 2016
  4. Study completionJun 2016

Resources

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)
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 22049286
  • 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.

    PubMed 11805748

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.

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