- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06352047
The Effects of Positioning After Extubation of Preterm Infants on the Respiratory Functions
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Trabzon, Turkey, 61080
- Karadeniz Technical University Health Application and Research Center Farabi Hospital
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Trabzon, Turkey, 61080
- İlknur Kahriman
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Supine position group
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.
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Position changes and the direction of the position (supine, prone, side lying) are recorded in the nurse observation form.
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Active Comparator: Prone position group
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.
|
Position changes and the direction of the position (supine, prone, side lying) are recorded in the nurse observation form.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Newborn Evaluation Form
Time Frame: 120 minutes
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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.
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120 minutes
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Karadeniz Tech. University
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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