The Effect of Positions on Physiological Parameters of Preterm Neonates Receiving Mechanical Ventilation

NCT05509621 | Completed

• 1 other identifier: SBU-KONUKBAY-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study was planned as an experimental study with a randomized crossover design to determine the effect of supine, prone, right lateral, left lateral, and quarter prone positions used during daily routine care in the neonatal intensive care unit on physiological parameters (oxygen saturation, heart rate, respiratory rate) of preterm neonates receiving mechanical ventilation.

Conditions

Preterm; Nursing Caries

Keywords

preterm neonate; position; mechanical ventilation; physiological parameters; nursing caries

Outcome Measures

Primary Outcomes (3)

• Heart Rate

  Beats per minute will be obtained using an electrocardiographic bedside monitor. An electrocardiographic bedside monitor will be placed on each of the babies.

  1 year

• Oxygen Saturation

  Oxygen saturation (SpO2) will be obtained using an electrocardiographic bedside monitor. A separate electrocardiographic bedside monitor will be placed for each of the babies.

  1 year

• Respiratory Rate

  Respiratory rate will be counted and recorded for 1 minute by the researcher.

  1 year

Study Arms (5)

Supine position

EXPERIMENTAL

To determine the effect of supine position used during daily routine care in the neonatal intensive care unit on physiological parameters (oxygen saturation, heart rate, respiratory rate).

Other: The Effect of Supine Position on Physiological Parameters in Mechanically Ventilated Preterm Newborns

Prone position

EXPERIMENTAL

To determine the effect of prone position used during daily routine care in the neonatal intensive care unit on physiological parameters (oxygen saturation, heart rate, respiratory rate).

Other: The Effect of Prone Position on Physiological Parameters in Mechanically Ventilated Preterm Newborns

Left lateral position

EXPERIMENTAL

To determine the effect of left lateral position used during daily routine care in the neonatal intensive care unit on physiological parameters (oxygen saturation, heart rate, respiratory rate).

Other: The Effect of left lateral Position on Physiological Parameters in Mechanically Ventilated Preterm Newborns

Right lateral position

EXPERIMENTAL

To determine the effect of right lateral position used during daily routine care in the neonatal intensive care unit on physiological parameters (oxygen saturation, heart rate, respiratory rate).

Other: The Effect of right lateral Position on Physiological Parameters in Mechanically Ventilated Preterm Newborns

Quarter prone position

EXPERIMENTAL

To determine the effect of quarter prone position used during daily routine care in the neonatal intensive care unit on physiological parameters (oxygen saturation, heart rate, respiratory rate).

Other: The Effect of Quarter prone Position on Physiological Parameters in Mechanically Ventilated Preterm Newborns

Interventions

The Effect of Supine Position on Physiological Parameters in Mechanically Ventilated Preterm Newborns OTHER

Preterm neonates who receive mechanical ventilation support and meet the study criteria will be provided with daily routine nursing care. Afterward, when it is time for positioning, the infant will be randomly placed in positions assigned according to the randomization. After positioning, data will not be collected for the first 30 minutes of each positioning in order to ensure the stability of the neonate. Starting from the 30th minute, the heart rate and oxygen saturation of the preterm neonate will be checked on the monitor at 15-minute intervals over the course of 90 minutes, and the respiratory rate will be counted and recorded for 1 minute by the researcher. For each position, the procedures will be repeated in the same way and the values will be recorded.

Supine position

The Effect of Prone Position on Physiological Parameters in Mechanically Ventilated Preterm Newborns OTHER

Preterm neonates who receive mechanical ventilation support and meet the study criteria will be provided with daily routine nursing care. Afterward, when it is time for positioning, the infant will be randomly placed in positions assigned according to the randomization. After positioning, data will not be collected for the first 30 minutes of each positioning in order to ensure the stability of the neonate. Starting from the 30th minute, the heart rate and oxygen saturation of the preterm neonate will be checked on the monitor at 15-minute intervals over the course of 90 minutes, and the respiratory rate will be counted and recorded for 1 minute by the researcher. For each position, the procedures will be repeated in the same way and the values will be recorded.

Prone position

The Effect of left lateral Position on Physiological Parameters in Mechanically Ventilated Preterm Newborns OTHER

Preterm neonates who receive mechanical ventilation support and meet the study criteria will be provided with daily routine nursing care. Afterward, when it is time for positioning, the infant will be randomly placed in positions assigned according to the randomization. After positioning, data will not be collected for the first 30 minutes of each positioning in order to ensure the stability of the neonate. Starting from the 30th minute, the heart rate and oxygen saturation of the preterm neonate will be checked on the monitor at 15-minute intervals over the course of 90 minutes, and the respiratory rate will be counted and recorded for 1 minute by the researcher. For each position, the procedures will be repeated in the same way and the values will be recorded.

Left lateral position

The Effect of right lateral Position on Physiological Parameters in Mechanically Ventilated Preterm Newborns OTHER

Preterm neonates who receive mechanical ventilation support and meet the study criteria will be provided with daily routine nursing care. Afterward, when it is time for positioning, the infant will be randomly placed in positions assigned according to the randomization. After positioning, data will not be collected for the first 30 minutes of each positioning in order to ensure the stability of the neonate. Starting from the 30th minute, the heart rate and oxygen saturation of the preterm neonate will be checked on the monitor at 15-minute intervals over the course of 90 minutes, and the respiratory rate will be counted and recorded for 1 minute by the researcher. For each position, the procedures will be repeated in the same way and the values will be recorded.

Right lateral position

The Effect of Quarter prone Position on Physiological Parameters in Mechanically Ventilated Preterm Newborns OTHER

Preterm neonates who receive mechanical ventilation support and meet the study criteria will be provided with daily routine nursing care. Afterward, when it is time for positioning, the infant will be randomly placed in positions assigned according to the randomization. After positioning, data will not be collected for the first 30 minutes of each positioning in order to ensure the stability of the neonate. Starting from the 30th minute, the heart rate and oxygen saturation of the preterm neonate will be checked on the monitor at 15-minute intervals over the course of 90 minutes, and the respiratory rate will be counted and recorded for 1 minute by the researcher. For each position, the procedures will be repeated in the same way and the values will be recorded.

Quarter prone position

Eligibility Criteria

• Age: 28 Weeks - 36 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• A gestational age of 28-36 weeks ,
• Receiving mechanical ventilation (non-intubated),
• Volunteer consent of the parents of the preterm neonate to participate in the study.

You may not qualify if:

• Receiving mechanical ventilation and being intubated,
• Having any congenital and genetic disorders,
• Having a health problem that prevents positioning,
• Having a chest tube, umbilical catheter or PICC line,
• Receiving continuous sedative therapy, anticonvulsive therapy and cardiac drug therapy,
• Frequent changes in mechanical ventilator settings,
• A feeding frequency of more than three hours.

Sponsors & Collaborators

• Saglik Bilimleri Universitesi Gulhane Tip Fakultesi: lead

Study Sites (1)

University of Health Sciences Turkey

Ankara, Turkey (Türkiye)

Location

Related Publications (6)

• Montgomery K, Choy NL, Steele M, Hough J. The effectiveness of quarter turn from prone in maintaining respiratory function in premature infants. J Paediatr Child Health. 2014 Dec;50(12):972-7. doi: 10.1111/jpc.12689. Epub 2014 Jul 13.

  PMID: 25039401 RESULT

• Utario Y, Rustina Y, Waluyanti FT. The Quarter Prone Position Increases Oxygen Saturation in Premature Infants Using Continuous Positive Airway Pressure. Compr Child Adolesc Nurs. 2017;40(sup1):95-101. doi: 10.1080/24694193.2017.1386976.

  PMID: 29166184 RESULT

• Yin T, Yuh YS, Liaw JJ, Chen YY, Wang KW. Semi-Prone Position Can Influence Variability in Respiratory Rate of Premature Infants Using Nasal CPAP. J Pediatr Nurs. 2016 Mar-Apr;31(2):e167-74. doi: 10.1016/j.pedn.2015.10.014. Epub 2015 Nov 21.

  PMID: 26614613 RESULT

• Brunherotti MA, Martinez EZ, Martinez FE. Effect of body position on preterm newborns receiving continuous positive airway pressure. Acta Paediatr. 2014 Mar;103(3):e101-5. doi: 10.1111/apa.12504. Epub 2013 Dec 20.

  PMID: 24354904 RESULT

• Gouna G, Rakza T, Kuissi E, Pennaforte T, Mur S, Storme L. Positioning effects on lung function and breathing pattern in premature newborns. J Pediatr. 2013 Jun;162(6):1133-7, 1137.e1. doi: 10.1016/j.jpeds.2012.11.036. Epub 2013 Jan 11.

  PMID: 23312684 RESULT

• Cakici M, Mutlu B. Effect of Body Position on Cardiorespiratory Stabilization and Comfort in Preterm Infants on Continuous Positive Airway Pressure. J Pediatr Nurs. 2020 Sep-Oct;54:e1-e8. doi: 10.1016/j.pedn.2020.06.015. Epub 2020 Jul 15.

  PMID: 32680615 RESULT

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

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

Study Officials

• DİLEK KONUKBAY

  Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: Preterm neonates to be included in the study will be placed in 5 different positions using a crossover design.In order not to repeat the order of positions,5 groups will be created as follows:ABCDE;BCDEA;CDEAB;DEABC;EABCD.The number of the groups created for not repeating the order of positions will be determined using the lottery method;Group1=CDEAB;Group2=BCDEA;Group3=EABCD;Group4=DEABC;Group5=ABCDE.Then,which position corresponds to which letter will be determined using the lottery method;A=quarter prone position,B=prone position,C=supine position,D=left lateral position,E=right lateral position.Afterward,40 preterm neonates will be randomly assigned to 5 groups using the block randomization method in line with the sample calculation. The order of the positions for the preterm neonate will be determined according to the position order of the group including the preterm infant.

Study Record Dates

• First Submitted: May 30, 2022
• First Posted: August 22, 2022
• Study Start: September 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: May 1, 2023
• Last Updated: December 28, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)