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

NCT06352047 | Completed

• 1 other identifier: Karadeniz Tech. University
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Premature Infants

Keywords

Extubation; Position; Premature; Supine; Prone

Outcome Measures

Primary Outcomes (1)

• 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.

  120 minutes

Study Arms (2)

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.

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.

Other: The effect of positioning on respiratory functions of preterm infants after extubation.

Interventions

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.

Prone position group; Supine position group

Eligibility Criteria

• Age: 37 Weeks - 37 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karadeniz Technical University: lead

Study Sites (2)

İlknur Kahriman

Trabzon, 61080, Turkey (Türkiye)

Location

Karadeniz Technical University Health Application and Research Center Farabi Hospital

Trabzon, 61080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premature Birth; Deception

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Social Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Prof. Dr

Model Details: 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).

Study Record Dates

• First Submitted: March 17, 2024
• First Posted: April 8, 2024
• Study Start: November 1, 2018
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: April 8, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)