Premature InfantsNCT06352047
The Effects of Positioning After Extubation of Preterm Infants on the Respiratory Functions
A study testing The effect of positioning on respiratory functions of preterm infants after extubation. in people with Premature Infants, run by Karadeniz Technical University at 2 sites in Turkey (Türkiye).
Trial summary
The aim of this study was to examine the effect of positioning on respiratory functions of preterm infants after extubation. Hypothesis 0a (H0a): There is no difference between the oxygen saturation (SpO2) levels of preterm infants in supine and prone positions after extubation. Read more about this study
- Who is it for?
- Ages 37 to 37 weeksHealthy volunteers can take part
- Conditions the study is for
- Premature Infants
- What is being tested?
- The effect of positioning on respiratory functions of preterm infants after extubation.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Nov 2018to 1 Jun 2019
- 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 37 to 37 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Endotracheal intubation was applied,
- Those whose gestational weeks are under 37+6 years of age,
- Parts of premature babies whose parents gave written consent to participate were included.
Who cannot join
- Developing pneumothorax,
- Those with congenital anomalies,
- Those with intracranial hemorrhage and/or periventricular leukomalacia,
- Surgery that may affect heart, circulation and respiratory functions or prevent supine/prone positioning,
- Not intubated,
- Premature babies whose parents gave up participating in the study were not included in the study.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
İlknur Kahriman
Trabzon, 61080
Karadeniz Technical University Health Application and Research Center Farabi Hospital
Trabzon, 61080
About this study
The aim of this study was to examine the effect of positioning on respiratory functions of preterm infants after extubation.
Hypothesis 0a (H0a): There is no difference between the oxygen saturation (SpO2) levels of preterm infants in supine and prone positions after extubation.
Hypothesis 0b (H0b): There is no difference between the respiratory rate of preterm infants in supine and prone positions after extubation.
Hypothesis 0c (H0c): There is no difference between the respiratory rhythms of preterm infants in supine and prone positions after extubation.
Hypothesis 0d (H0d): There is no difference between respiratory distress in preterm infants in supine and prone positions after extubation.
Read the detailed description
Among infants in the neonatal intensive care unit (NICU), the ones in the high and medium risk group are premature infants. Respiratory distress is the most important problem in infants with a history of preterm birth due to undeveloped systems and organs. Especially premature infants need respiratory support in the NICU. The most important stage of supportive treatment is the application of mechanical ventilation with endotracheal intubation. Newborns receiving mechanical ventilation support should be checked constantly Considering that endotracheal intubation may cause extreme stress and traumatic effects on premature babies, it should be ensured that premature babies get through the ventilation process and afterward with minimal trauma. This will positively affect the adaptation process after the termination of intubation. The neonatal nurse continuously monitors the changes in heart rate, body temperature, blood pressure, SpO2, respiratory characteristics and number of infants receiving mechanical ventilation and records them in the patient follow-up form. The nurse tries to provide the most ideal respiratory form in infants with mechanical ventilation. For this reason, neonatal nurses should provide individualized developmental nursing care by considering all the physiological needs of premature babies in order to provide the most ideal respiratory form. The use of individualized care models in premature babies increases the health quality and social cohesion of preterm babies. It fastens the physiological recovery, shortens the hospital stay and increases neurodevelopmental functions. Positionig is one of the most important developmental supportive activities. It is important in nursing care to position the preterm babies appropriately and to ensure its continuity according to their needs. It is recommended that preterm infants with respiratory distress in the NICU should be placed in the supine position after extubation when respiratory patterns are stabilized. It has been observed that the prone position increases oxygen saturation in premature babies, shortens the duration of mechanical ventilator therapy, decreases re-intubation after extubation, decreases neonatal apnea, and contributes to the development of respiratory muscles and positively affects respiratory functions. In addition, the prone position increases the lung capacity of preterm infants. Studies show that the prone position improves diaphragmatic function, increases lung perfusion, and has positive effects on respiratory functions. In another study, it was stated that the prone position is a safe and healthy process according to the order of separation from mechanical ventilation and may contribute to the success of separation from mechanical ventilation in preterm infants [4]. The neonatal nurse should be aware of the importance of positioning and should be able to position the newborn baby when needed in routine care practices. During the respiratory system intubation period and after extubation, the effects of the positioning on the respiratory functions of the preterm should be observed and the position with the highest benefit should be taken into consideration when performing individualized nursing care. Therefore, the aim of this study was to examine the effect of positioning on respiratory functions of preterm infants after extubation.
- Conditions
- Premature Infants
- Being tested
- The effect of positioning on respiratory functions of preterm infants after extubation.
- Keywords
- Extubation, Position, Premature, Supine, Prone
- Medical subject headings
- Premature Birth, Deception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The effect of positioning on respiratory functions of preterm infants after extubation.Other
Position changes and the direction of the position (supine, prone, side lying) are recorded in the nurse observation form.
| Study group | Role | What they receive |
|---|---|---|
| Supine position group | Experimental | Supine position group Before starting the study, parents of preterm infants were informed about the study, and the infants of parents who agreed to participate in the study were divided into two groups as prone and supine positions. In the study, preterm babies positioned after extubation by the researcher. Before extubation, SpO2, respiratory rate (to be counted for one minute), blood pressure, blood gas values were checked and recorded from the bedside monitor of the babies planned for extubation. Before leaving the mechanical ventilator for preterm newborns who were decided for extubation and met the research criteria, vibration and percussion were performed to premature babies over 1500 g with a mouth mask or palm dome. Oral, nasal and oranazopharynx were aspirated for 3-5 seconds with an appropriate aspiration catheter (6-8 Fr) at a pressure not exceeding 100 mmHg. Receives: Other: The effect of positioning on respiratory functions of preterm infants after extubation. |
| Prone position group | Active comparator | Prone position group Before starting the study, parents of preterm infants were informed about the study, and the infants of parents who agreed to participate in the study were divided into two groups as prone and supine positions. In the study, preterm babies positioned after extubation by the researcher. Before extubation, SpO2, respiratory rate (to be counted for one minute), blood pressure, blood gas values obtained from the heel blood of the Preterm baby were checked on the bedside monitor and recorded before extubation. Before leaving the mechanical ventilator for preterm newborns who were decided for extubation and met the research criteria, vibration and percussion were performed to premature babies over 1500 g with a mouth mask or palm dome. Oral, nasal and oranazopharynx were aspirated for 3-5 seconds with an appropriate aspiration catheter (6-8 Fr) at a pressure not exceeding 100 mmHg. Receives: Other: The effect of positioning on respiratory functions of preterm infants after extubation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Newborn Evaluation Form
After the positioning, vital measurements (fever, HR, blood pressure), respiratory characteristics (number, rhythm, distress), SpO2 values were recorded. These infants were monitored for 120 minutes. Every 30 minutes, respiratory rate, HR, SpO2 were evaluated from the bedside monitor. After 60 minutes, blood gas parameters were evaluated. The presence of desaturation, apnea, and cyanosis was observed within 120 minutes and recorded in the data collection forum. During this process, the researcher stayed with the baby and recorded the measurement results and other observed findings on the observation form.
Measured: 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start1 Nov 2018
- Primary completion1 Jun 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature InfantsStudies 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
- Parallel groups
- Model description
- Simple randomization method was used in the sample of the study. In previous studies, there were no published data on the effect of supine and prone positioning after extubation on the pulmonary functions of premature infants. Therefore, the sample size was calculated using the G-power 3.1.3 program according to the SpO2 level and standard deviation values of 4 infants who were mechanically ventilated in the neonatal intensive care unit. The study was conducted with a total of 42 premature babies, two groups of 21 premature babies, each of whom had the characteristics of the research groups. Premature infants were divided into two groups, the supine position and the prone group, by randomization using a computer-based random number generator (www.randomizer.org).
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İlknur KAHRİMAN, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06352047
- Sponsor's protocol ID
- Karadeniz Tech. University
- Status last verified
- Apr 2024
- First submitted
- 17 Mar 2024
- Last updated
- 8 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Positioning After Extubation of Preterm Infants on the Respiratory Functions
- ClinicalTrials.gov ID
- NCT06352047
- Acronym / sponsor ID
- Karadeniz Tech. University
- Conditions
- Premature Infants
- Keywords
- Extubation, Position, Premature, Supine, Prone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 8 Apr 2024 (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.
The aim of this study was to examine the effect of positioning on respiratory functions of preterm infants after extubation.
Hypothesis 0a (H0a): There is no difference between the oxygen saturation (SpO2) levels of preterm infants in supine and prone positions after extubation.
Hypothesis 0b (H0b): There is no difference between the respiratory rate of preterm infants in supine and prone positions after extubation.
Hypothesis 0c (H0c): There is no difference between the respiratory rhythms of preterm infants in supine and prone positions after extubation.
Hypothesis 0d (H0d): There is no difference between respiratory distress in preterm infants in supine and prone positions after extubation.
Detailed description
Among infants in the neonatal intensive care unit (NICU), the ones in the high and medium risk group are premature infants. Respiratory distress is the most important problem in infants with a history of preterm birth due to undeveloped systems and organs. Especially premature infants need respiratory support in the NICU. The most important stage of supportive treatment is the application of mechanical ventilation with endotracheal intubation. Newborns receiving mechanical ventilation support should be checked constantly Considering that endotracheal intubation may cause extreme stress and traumatic effects on premature babies, it should be ensured that premature babies get through the ventilation process and afterward with minimal trauma. This will positively affect the adaptation process after the termination of intubation. The neonatal nurse continuously monitors the changes in heart rate, body temperature, blood pressure, SpO2, respiratory characteristics and number of infants receiving mechanical ventilation and records them in the patient follow-up form. The nurse tries to provide the most ideal respiratory form in infants with mechanical ventilation. For this reason, neonatal nurses should provide individualized developmental nursing care by considering all the physiological needs of premature babies in order to provide the most ideal respiratory form. The use of individualized care models in premature babies increases the health quality and social cohesion of preterm babies. It fastens the physiological recovery, shortens the hospital stay and increases neurodevelopmental functions. Positionig is one of the most important developmental supportive activities. It is important in nursing care to position the preterm babies appropriately and to ensure its continuity according to their needs. It is recommended that preterm infants with respiratory distress in the NICU should be placed in the supine position after extubation when respiratory patterns are stabilized. It has been observed that the prone position increases oxygen saturation in premature babies, shortens the duration of mechanical ventilator therapy, decreases re-intubation after extubation, decreases neonatal apnea, and contributes to the development of respiratory muscles and positively affects respiratory functions. In addition, the prone position increases the lung capacity of preterm infants. Studies show that the prone position improves diaphragmatic function, increases lung perfusion, and has positive effects on respiratory functions. In another study, it was stated that the prone position is a safe and healthy process according to the order of separation from mechanical ventilation and may contribute to the success of separation from mechanical ventilation in preterm infants [4]. The neonatal nurse should be aware of the importance of positioning and should be able to position the newborn baby when needed in routine care practices. During the respiratory system intubation period and after extubation, the effects of the positioning on the respiratory functions of the preterm should be observed and the position with the highest benefit should be taken into consideration when performing individualized nursing care. Therefore, the aim of this study was to examine the effect of positioning on respiratory functions of preterm infants after extubation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Simple randomization method was used in the sample of the study. In previous studies, there were no published data on the effect of supine and prone positioning after extubation on the pulmonary functions of premature infants. Therefore, the sample size was calculated using the G-power 3.1.3 program according to the SpO2 level and standard deviation values of 4 infants who were mechanically ventilated in the neonatal intensive care unit. The study was conducted with a total of 42 premature babies, two groups of 21 premature babies, each of whom had the characteristics of the research groups. Premature infants were divided into two groups, the supine position and the prone group, by randomization using a computer-based random number generator (www.randomizer.org).
| Arm | Type | Receives |
|---|---|---|
| Supine position group | Experimental | Other: The effect of positioning on respiratory functions of preterm infants after extubation.Supine position group Before starting the study, parents of preterm infants were informed about the study, and the infants of parents who agreed to participate in the study were divided into two groups as prone and supine positions. In the study, preterm babies positioned after extubation by the researcher. Before extubation, SpO2, respiratory rate (to be counted for one minute), blood pressure, blood gas values were checked and recorded from the bedside monitor of the babies planned for extubation. Before leaving the mechanical ventilator for preterm newborns who were decided for extubation and met the research criteria, vibration and percussion were performed to premature babies over 1500 g with a mouth mask or palm dome. Oral, nasal and oranazopharynx were aspirated for 3-5 seconds with an appropriate aspiration catheter (6-8 Fr) at a pressure not exceeding 100 mmHg. |
| Prone position group | Active comparator | Other: The effect of positioning on respiratory functions of preterm infants after extubation.Prone position group Before starting the study, parents of preterm infants were informed about the study, and the infants of parents who agreed to participate in the study were divided into two groups as prone and supine positions. In the study, preterm babies positioned after extubation by the researcher. Before extubation, SpO2, respiratory rate (to be counted for one minute), blood pressure, blood gas values obtained from the heel blood of the Preterm baby were checked on the bedside monitor and recorded before extubation. Before leaving the mechanical ventilator for preterm newborns who were decided for extubation and met the research criteria, vibration and percussion were performed to premature babies over 1500 g with a mouth mask or palm dome. Oral, nasal and oranazopharynx were aspirated for 3-5 seconds with an appropriate aspiration catheter (6-8 Fr) at a pressure not exceeding 100 mmHg. |
Who may qualify
- Ages
- 37 to 37 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Endotracheal intubation was applied,
Key exclusion criteria (6 listed)
- Developing pneumothorax,
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 positioning on respiratory functions of preterm infants after extubation.Position changes and the direction of the position (supine, prone, side lying) are recorded in the nurse observation form. | Other | Prone position group, Supine position group |
Primary outcome
Newborn Evaluation Form
Time frame: 120 minutes
After the positioning, vital measurements (fever, HR, blood pressure), respiratory characteristics (number, rhythm, distress), SpO2 values were recorded. These infants were monitored for 120 minutes. Every 30 minutes, respiratory rate, HR, SpO2 were evaluated from the bedside monitor. After 60 minutes, blood gas parameters were evaluated. The presence of desaturation, apnea, and cyanosis was observed within 120 minutes and recorded in the data collection forum. During this process, the researcher stayed with the baby and recorded the measurement results and other observed findings on the observation form.
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 8 Apr 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites 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 positioning on respiratory functions of preterm infants after extubation. in people with Premature Infants, run by Karadeniz Technical University at 2 sites 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 6 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 8 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Newborn Evaluation Form (time frame: 120 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Apr 2024; AzTrials last refreshed its copy on 8 Nov 2026.