Effects of Two Modalities of Non-invasive Ventilation After Extubation in Very Low Birth Weight Neonates

NCT03551314 | Completed

• 1 other identifier: CAAE: 67787917.7.0000.5149
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 2

Brief Summary

The objective of this study is to evaluate the effects of continuous positive airway pressure and nasal intermittent positive pressure ventilation on breathing pattern variables of very low birth weight neonates immediately after extubation.

Conditions

Preterm Infant

Keywords

Non-invasive ventilation; Preterm infant; Breathing pattern

Outcome Measures

Primary Outcomes (1)

• Tidal volume

  Defined as the volume of air entering or exiting the lungs during each breath - in millilitres.

  Measure during the two non-invasive ventilation strategies. Tidal volume will be measured for 2 hours, one hour in continuous positive airway pressure and one hour in nasal intermittent positive pressure ventilation.

Secondary Outcomes (8)

• Respiratory rate

  Measure during the two non-invasive ventilation strategies. Respiratory rate will be measured for 2 hours, one hour in continuous positive airway pressure and one hour in nasal intermittent positive pressure ventilation.

• Minute ventilation

  Measure during the two non-invasive ventilation strategies. Minute ventilation will be measured for 2 hours, one hour in continuous positive airway pressure and one hour in nasal intermittent positive pressure ventilation.

• Mean inspiratory flow

  Measure during the two non-invasive ventilation strategies. Mean inspiratory flow will be measured for 2 hours, one hour in continuous positive airway pressure and one hour in nasal intermittent positive pressure ventilation.

• Labored Breathing Index (LBI)

  Measure during the two non-invasive ventilation strategies. Labor breathing index (LBI) will be measured for 2 hours, one hour in continuous positive airway pressure and one hour in nasal intermittent positive pressure ventilation.

• Phase relation in inspiratory breathing (PhRIB)

  Measure during the two non-invasive ventilation strategies. Phase relation in inspiratory breathing will be measured for 2 hours, one hour in continuous positive airway pressure and one hour in nasal intermittent positive pressure ventilation.

Study Arms (2)

Nasal Intermittent Positive Pressure

ACTIVE COMPARATOR

In this group, soon after extubation, the newborns will be studied initially in NIPPV for one hour. Infants will be studied in supine while in their incubator. NIPPV: Nasal Intermittent Positive Pressure Ventilation

Other: Nasal Intermittent Positive Pressure

Continuous Positive Airway Pressure

ACTIVE COMPARATOR

In this group, soon after extubation, the newborns will be studied initially in CPAP for one hour. Infants will be studied in supine while in their incubator. CPAP: Continuous Positive Airway Pressure

Other: Continuous Positive Airway Pressure

Interventions

Nasal Intermittent Positive Pressure OTHER

\- NIPPV The following parameters: inspiratory pressure = 15 cmH2O / final expiratory positive pressure = 6 cmH2O / inspiratory time = 0.40 / flow = 6-8 L.min-1 / respiratory rate = 24. Respiratory inductive plethysmography is used to evaluate breathing pattern (tidal volume, respiratory rate, minute ventilation, mean inspiratory flow) and chest wall motion (labor breathing index - LBI, phase relation in inspiratory breathing - PhRIB, phase relation in expiratory breathing - PhREB, total phase relation - PhRTB and phase angle).

Nasal Intermittent Positive Pressure

Continuous Positive Airway Pressure OTHER

\- CPAP The following parameters: pressure of 6 cmH2O, with flow of 6-8L/min. Respiratory inductive plethysmography is used to evaluate breathing pattern (tidal volume, respiratory rate, minute ventilation, mean inspiratory flow) and chest wall motion (labor breathing index - LBI, phase relation in inspiratory breathing - PhRIB, phase relation in expiratory breathing - PhREB, total phase relation - PhRTB and phase angle).

Continuous Positive Airway Pressure

Eligibility Criteria

• Age: Up to 32 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Presented gestational age less than or equal to 32 weeks and weight less than or equal to 1,500 g;
• Stability from an hemodynamic point of view (without use of amines);
• Have undergone invasive mechanical ventilation;
• Absence of congenital heart diseases and / or other congenital anomalies (myelomeningocele, gastroschisis and / or omphalocele) or chromosomal abnormalities;
• Absence of any condition that requires surgery in the neonatal period.

You may not qualify if:

• Presented air leak syndrome (pneumothorax, pneumomediastinum); upper airway obstruction after extubation and non-scheduled extubation.

Sponsors & Collaborators

• Federal University of Minas Gerais: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (2)

Hospital das Clínicas da UFMG

Belo Horizonte, Minas Gerais, 30130-100, Brazil

Location

Laboratório de Avaliação e Pesquisa em Desempenho Cardiorrespiratório da UFMG

Belo Horizonte, Minas Gerais, 31270-901, Brazil

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Verônica F Parreira, PhD

  Federal University of Minas Gerais

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: May 15, 2018
• First Posted: June 11, 2018
• Study Start: May 26, 2017
• Primary Completion: July 26, 2018
• Study Completion: July 26, 2018
• Last Updated: February 21, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)