The Effects of Positioning After Extubation of Preterm Infants on the Respiratory Functions

April 1, 2024 updated by: İlknur KAHRİMAN, Karadeniz Technical University

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

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 Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Trabzon, Turkey, 61080
        • Karadeniz Technical University Health Application and Research Center Farabi Hospital
      • Trabzon, Turkey, 61080
        • İlknur Kahriman

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Position changes and the direction of the position (supine, prone, side lying) are recorded in the nurse observation form.
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
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.
120 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2018

Primary Completion (Actual)

June 1, 2019

Study Completion (Actual)

June 1, 2019

Study Registration Dates

First Submitted

March 17, 2024

First Submitted That Met QC Criteria

April 1, 2024

First Posted (Actual)

April 8, 2024

Study Record Updates

Last Update Posted (Actual)

April 8, 2024

Last Update Submitted That Met QC Criteria

April 1, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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