Changes in Respiratory Effort in Preterm Infants

NCT02014493 | Completed

• 1 other identifier: HHB-2013
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

Continuous Positive Airway Pressure (CPAP) is used to treat preterm infants with an immature respiratory center and having respiratory distress. CPAP requires intensive care monitoring and special qualified staff. Continuous positive pressure makes a constant noise around the child and can lead to an uncomfortable environment.The fixture of the binasal prongs can cause nasal trauma after to tight attachment.Minimizing the time on CPAP is considered important for the child. Recently High-Flow Nasal Cannula (HFNC) has become widely used in modern newborn intensive care units.HFNC is considered to be easy to apply and a more comfortable respiratory support for the preterm infant with mild and moderate respiratory distress. HFNC gives warm humified air with high flow through a nasal cannulae. HFNC is used as part of withdrawal from intensive respiratory support, to prevent respiratory distress and as a respiratory support after extubation. There is still uncertainty about safety and effectiveness of HFNC. The aim of this study is to investigate the preterm infants respiratory effort by measuring electrical activity in diaphragm (Edi max and Edi min), respiratory parameters and a clinical observation using a scoring system inspired by Silverman- Andersen retraction score. It is expected that measured electrical activity in the diaphragm, measured respiratory parameters combined with bedside observations provide applicable knowledge about preterm infants respiratory effort in transition from CPAP to HFNC.

Conditions

Premature Birth

Keywords

Respiration; Noninvasive Ventilation; Work of breathing; Infant, premature; Electromyography; Diaphragm

Outcome Measures

Primary Outcomes (1)

• Neural control of respiration

  reflected by electrical activity of the diaphragm (Edi): inspiratory drive (Edi peak) and tonic activity (Edi min). A nasogastric feeding tube with ten microsensors will measure action potentials from the phrenic nerve to the diaphragm.

  4 months

Secondary Outcomes (1)

• Respiratory signs

  4 months

Study Arms (2)

HFNC first

ACTIVE COMPARATOR

4 hours with High Flow Nasal Cannulae (HFNC) 6 l/pr.min, then 4 hours with Continuous Positive Airway Pressure (CPAP) 6l/pr.min.

Procedure: High Flow Nasal Cannulae (HFNC)

CPAP first

ACTIVE COMPARATOR

4 hours Continuous Positive Airway Pressure (CPAP) 6 l/pr.min, then 4 hours High Flow Nasal Cannulae (HFNC) 6 l/pr.min.

Procedure: Continuous Positive Airway Pressure (CPAP)

Interventions

High Flow Nasal Cannulae (HFNC) PROCEDURE

HFNC 6 l/pr.min

HFNC first

Continuous Positive Airway Pressure (CPAP) PROCEDURE

CPAP 6 l/pr.min

CPAP first

Eligibility Criteria

• Age: 28 Weeks - 34 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Preterm infants who are stable on Nasal Continuous Positive Airway Pressure (nCPAP) with flow 8l/min
• \<34 and \>28 gestational weeks, respiratory stable last 72 hours.
• kilo
• Fi02\< 30%
• C02\<9
• written informed consent by parents/caregivers

You may not qualify if:

• need for sedation
• damage on the phrenic nerve
• anomalies in the upper airways

Sponsors & Collaborators

• St. Olavs Hospital: lead
• Norwegian University of Science and Technology: collaborator

Study Sites (1)

Newborn Intensive Care Unit, St Olavs Hospital

Trondheim, Norway

Location

Related Publications (1)

• Brenne H, Grunewaldt KH, Follestad T, Bergseng H. A randomised cross-over study showed no difference in diaphragm activity during weaning from respiratory support. Acta Paediatr. 2018 Oct;107(10):1726-1732. doi: 10.1111/apa.14303. Epub 2018 Apr 4.

  PMID: 29504671 RESULT

MeSH Terms

Conditions

Premature Birth; Respiratory Aspiration

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Håkon Bergseng, MD PhD

  St. Olavs Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2013
• First Posted: December 18, 2013
• Study Start: January 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: March 8, 2018

Record last verified: 2018-03

Locations

NO (1)