Effects of Prone Positioning on Vital Parameters in Infants With Acute Bronchiolitis

NCT04748159 | Completed

• 1 other identifier: RSV Bronchiolitis
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

This intervention study is designed to evaluate short-term effects (within one hour) of prone position on vital signs in infants under 12 months of age with acute RSV bronchiolitis. The primary objective is to investigate whether respiratory rate changes in prone position. Secondary endpoints are changes in oxygen saturation (SpO2), transcutaneous carbon dioxide partial pressure (pCO2), heart rate, and respiratory symptoms assessed by the Modified Tal Score (MTS).

Conditions

Respiratory Syncytial Virus (RSV); Acute Bronchiolitis; Infant, Newborn, Disease; Infant, Premature, Diseases

Keywords

Abdominal Position; Respiratory Rate; Prone Position

Outcome Measures

Primary Outcomes (1)

• Change of the respiratory rate at 45-75 minutes

  This parameter is determined first and by visual observation of the respective PPT. The breaths are counted in a period of one minute.

  Time 3 = Change from baseline at 45-75 minutes.

Secondary Outcomes (19)

• Respiratory rate: Baseline

  Time 0 = Collection of measurement data for the baseline. Repositioning of the child in prone position.

• Change of the respiratory rate at 1 minute

  Time 1 = Change from baseline at 1 minute.

• Change of the respiratory rate at 10 minutes

  Time 2 = Change from baseline at 10 minutes.

• Oxygen saturation (SpO2): Baseline

  Time 0: Collection of measurement data for the baseline. Repositioning of the child in prone position.

• Change of oxygen saturation at 1 minute

  Time 1 = Change from baseline at 1 minute.

Study Arms (1)

Infants in prone position

EXPERIMENTAL

The purpose of this intervention study is to evaluate short-term effects (within one hour) of prone positioning on vital signs in infants under 12 months of age with acute RSV bronchiolitis.

Other: Prone position/ Abdominal position

Interventions

Prone position/ Abdominal position OTHER

Standardized positioning of the infant in the prone position respectively abdominal position. Depending on age and size, one or two rolled towels are placed lengthwise under the baby. Both arms are placed cranially in U-position towards the head. Since the position of the head has no significant influence on lung ventilation, the head is placed according to the infant's tolerance.

Infants in prone position

Eligibility Criteria

• Age: 0 Months - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants hospitalized due to RSV at the Lucerne Children's Hospital in the 2020 RSV season
• Infants under twelve months with a mild to moderate severity of acute bronchiolitis
• positive RSV Test: rapid antigen test or detection of nucleic acids by PCR in nasopharyngeal secretion

You may not qualify if:

• Infants who are in a life-threatening condition and require intensive care

Sponsors & Collaborators

• Luzerner Kantonsspital: lead

Study Sites (1)

Kinderspital Luzern

Lucerne, 6000, Switzerland

Location

MeSH Terms

Conditions

Disease; Infant, Premature, Diseases

Interventions

Prone Position

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Nicolas Regamey, MD

  Luzerner Kinderspital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Paediatric Pulmonology

Study Record Dates

• First Submitted: December 7, 2020
• First Posted: February 10, 2021
• Study Start: January 3, 2020
• Primary Completion: March 23, 2020
• Study Completion: March 31, 2020
• Last Updated: March 26, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)