Comparison of Leakage With Nasal Prongs and Nasal Mask Interface in Newborns Receiving CPAP Treatment

NCT03586856 | Completed

• 1 other identifier: 2016/2449-31
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

The study is a two-armed randomized cross-over comparison of leakage with nasal prongs and nasal mask interface in newborn infants treated with CPAP, born after 28 weeks of gestational age. For infants with an interface leakage, the trial also includes an observational part evaluating simple measures to reduce leakage. The study will be carried out in the Karolinska University Hospital Stockholm and in the Östersund Hospital.

Conditions

Infant,Premature; Respiration; Insufficient or Poor, Newborn

Keywords

Continuous positive airway pressure; Air Leakage; Work of breathing

Outcome Measures

Primary Outcomes (1)

• Leakage in the CPAP system

  Measurement of absolute leakage (at interface or mouth) using flowmeters connected to the CPAP device in flow through position (L/min, 30 seconds recording)

  0-60 min

Secondary Outcomes (5)

• Inspired oxygen level (FiO2)

  0-60 min

• Level of CPAP support (cmH2O)

  0-60 min

• Peripheral oxygen saturation (SpO2)

  0-60 min

• Measurement completion possible (yes/no)

  0-60 min

• Effect of simple measures to reduce leakage (L/min)

  0-60 min

Other Outcomes (9)

• Safety variable: Desaturation during measurement

  0 to competition of measurement (maximum 3 hours)

• Safety variable: Apneas during measurement

  0 to competition of measurement (maximum 3 hours)

• Safety variable: FiO2 adjustments during measurement

  0 to competition of measurement (maximum 3 hours)

Study Arms (2)

Nasal mask interface

ACTIVE COMPARATOR

The CPAP interface will be applied and adjusted by experienced staff blinded to the outcome variable; leakage. Measures to reduce/minimize leakage are tested in an unblinded observational part after the intervention.

Device: Nasal mask interface

Nasal prongs interface

ACTIVE COMPARATOR

The CPAP interface will be applied and adjusted by experienced staff blinded to the outcome variable; leakage. Measures to reduce/minimize leakage are tested in an unblinded observational part after the intervention.

Device: Nasal prongs interface

Interventions

Nasal mask interface DEVICE

Nasal masks is a standard interface used for CPAP treatment of newborn infants. The CPAP device allows for easily switching between the nasal prongs or nasal mask interface as well as adjustment of size.

Nasal mask interface

Nasal prongs interface DEVICE

Nasal masks is a standard interface used for CPAP treatment of newborn infants. The CPAP device allows for easily switching between the nasal prongs or nasal mask interface as well as adjustment of size.

Nasal prongs interface

Eligibility Criteria

• Age: Up to 44 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patient receiving respiratory support with CPAP

You may not qualify if:

• Airway, pulmonary, cardiac or gastro-intestinal malformations
• Neuromuscular disease
• Circulatory unstable patient
• FiO2 higher than 0.5
• Nasal damage or major skin irritation.
• Extubation less than 24 h before investigation
• Surgery less than 5 days before investigation

Sponsors & Collaborators

• Baldvin Jonsson: lead

Study Sites (2)

Östersund hospital

Östersund, Jämtland County, 83143, Sweden

Location

Karolinska University Hospital, Neonatology department

Stockholm, 171 76, Sweden

Location

Related Publications (1)

• Gunnarsdottir K, Falk M, Baldursdottir S, Donaldsson S, Jonsson B, Drevhammar T. Do newborn infants exhale through the CPAP system? Secondary analysis of a randomised cross-over trial. Arch Dis Child Fetal Neonatal Ed. 2023 May;108(3):232-236. doi: 10.1136/archdischild-2022-324462. Epub 2022 Oct 19.

  PMID: 36261145 DERIVED

MeSH Terms

Conditions

Respiratory Aspiration; Premature Birth

Condition Hierarchy (Ancestors)

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

Study Officials

• Baldvin Jonsson, MD, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Main study design: Two armed randomized cross-over comparison of leakage for two interfaces. The trial also investigates simple measures to reduce leakage (observational)

Study Record Dates

• First Submitted: June 4, 2018
• First Posted: July 16, 2018
• Study Start: August 1, 2018
• Primary Completion: October 26, 2019
• Study Completion: October 26, 2019
• Last Updated: November 13, 2019

Record last verified: 2019-11

Locations

SE (2)