Prone and Supine Positions in Preterm Infants Receiving Mechanical Ventilation

NCT03895242 | Completed

• 1 other identifier: AkdenizU
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

Positioning, which is one of the individualized developmental care methods, is known as the important care support process which is applied with the purpose of ensuring the least damage from the environmental. Positioning in preterm infants is the basis of neonatal nursing care. Positioning in preterm infants receiving mechanical ventilation support is important in terms of physiological and neurodevelopment. In infants undergoing respiratory support in NICU, it is important to determine the appropriate position, the frequency and duration of position change in order to reduce the oxygen need. In this respect, the aim of this study, designed as a randomized controlled trial, was to determine the effect of supine and prone positions on physiological variables (oxygen saturation and heart rate) of preterm infants receiving mechanical ventilation.

Conditions

Preterm Infant; Ventilator Lung; Newborn; Preterm Birth

Keywords

Preterm infant; Mechanical ventilation; Position

Outcome Measures

Primary Outcomes (2)

• Heart Rate

  The number of heartbeats per minute was obtained using a pulse oximetry device. A separate pulse oximetry probe was inserted into each of the infants.

  An average of 2 year

• Oxygen Saturation

  Oxygen saturation (SpO2) was obtained using a pulse oximetry device. A separate pulse oximetry probe was inserted into each of the infants.

  An average of 2 year

Study Arms (2)

Group 1:First supine position,then prone position

EXPERIMENTAL

First group was supine position then prone position.

Behavioral: Group 1:Supine-Prone

Group 2:First prone position, then supine position

EXPERIMENTAL

Second group was first prone position, then supine position.

Behavioral: Group 2:Prone-Supine

Interventions

Group 1:Supine-Prone BEHAVIORAL

After the infants were treated and fed, supine position was first given and waited for 60 minutes to stabilise (no data was collected during this time). After 61 minutes, it was allowed to stay in supine position for 2 hours. From the 61st minute, heart rate and oxygen saturation were evaluated in each infant in the supine positions at intervals of 15 min over a period of 120 min. At the end of two hours, the infant was given the prone position after the routine requirements such as diaper replacement were completed. Infants were waiting for 60 minutes to stabilize after the prone position (no data was collected during this time). From the 61st minute, heart rate and oxygen saturation were evaluated in each infant in the prone positions at intervals of 15 min over a period of 120 min.

Group 1:First supine position,then prone position

Group 2:Prone-Supine BEHAVIORAL

After the infants were treated and fed, prone position was first given and waited for 60 minutes to stabilise (no data was collected during this time). After 61 minutes, it was allowed to stay in prone position for 2 hours. From the 61st minute, heart rate and oxygen saturation were evaluated in each infant in the prone positions at intervals of 15 min over a period of 120 min. At the end of two hours, the infant was given the supine position after the routine requirements such as diaper replacement were completed. Infants were waiting for 60 minutes to stabilize after the supine position (no data was collected during this time). From the 61st minute, heart rate and oxygen saturation were evaluated in each infant in the prone positions at intervals of 15 min over a period of 120 min.

Group 2:First prone position, then supine position

Eligibility Criteria

• Age: 1 Day - 7 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Gestation week from 25 to 36 weeks
• Spontaneous breathing with mechanical ventilation (required ventilatory support and at least 12 hours in nasal continuous positive airway pressure therapy),
• Postnatal age ≤ 7 days,

You may not qualify if:

• Neuromuscular disease,
• Pulmonary arterial hypertension,
• Emphysema,
• Active bleeding,
• Respiratory problem due to heart disease,
• Obstacle to give birth position congenital disorder,
• Abdominal or thoracic surgery,
• Hypothermia and hyperthermia,
• Chest with tube,
• Continuous sedative treatment,
• Anticonvulsive therapy and cardiac drug therapy,
• Mechanical ventilator settings vary frequently,
• Preterm neonates with a frequency of more than three hours were not included in the study.

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Health Sciences University Education and Research Hospital, Neonatal Intensive Care Unit

Antalya, Turkey (Türkiye)

Location

Related Publications (2)

• Abdeyazdan Z, Nematollahi M, Ghazavi Z, Mohhamadizadeh M. The effects of supine and prone positions on oxygenation in premature infants undergoing mechanical ventilation. Iran J Nurs Midwifery Res. 2010 Fall;15(4):229-33.

  PMID: 22049286 BACKGROUND

• Chang YJ, Anderson GC, Dowling D, Lin CH. Decreased activity and oxygen desaturation in prone ventilated preterm infants during the first postnatal week. Heart Lung. 2002 Jan-Feb;31(1):34-42. doi: 10.1067/mhl.2002.120241.

  PMID: 11805748 BACKGROUND

MeSH Terms

Conditions

Premature Birth; Bronchopulmonary Dysplasia

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Emine EFE

  Akdeniz University Children's Health and the Nursing Department

  STUDY DIRECTOR

• Sultan Beşiktaş

  Antalya Health Sciences University Education and Research Hospital

  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: Graduate Nurse

Model Details: The priority of the positions to be given to preterm infants was randomly determined.The positions of preterm infants was identified using the closed envelope method.The positions of infants were written in envelopes and closed.The clinical nurse, who was not in the research, pulled the envelope and identified the infant position.First group was first supine position,then prone position (n = 19), second group was first prone position, then supine position (n = 19).

Study Record Dates

• First Submitted: March 24, 2019
• First Posted: March 29, 2019
• Study Start: February 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: March 29, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)