NCT04326270

Brief Summary

Crossover bedside clinical study to examine relative tidal volume delivery during nasal intermittent positive pressure ventilation (NIPPV) and directly compare the RAM® infant cannula to a nasal continuous positive airway pressure (nCPAP) delivery system in vivo. The study population will consist of preterm neonates with mild respiratory insufficiency who are receiving NIPPV, non-invasive neurally adjusted ventilatory assist (NIV NAVA), or nCPAP.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 7, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 26, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 30, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

March 30, 2020

Status Verified

March 1, 2020

Enrollment Period

1.3 years

First QC Date

March 26, 2020

Last Update Submit

March 26, 2020

Conditions

Respiratory Distress Syndrome in Premature Infant

Keywords

nasal intermittent positive pressure ventilationnon-invasive ventilationnasal continuous positive airway pressure prongsinfant nasal cannulatidal volume

Outcome Measures

Primary Outcomes (3)

  • Relative tidal volume delivery, breath type I

    Relative tidal volume measured in arbitrary units (AU) via RIP bands during synchronized breaths

    1 hour

  • Relative tidal volume delivery, breath type II

    Relative tidal volume measured in arbitrary units (AU) via RIP bands during ventilator-driven breaths

    1 hour

  • Relative tidal volume delivery, breath type III

    Relative tidal volume measured in arbitrary units (AU) via RIP bands during patient-driven breaths

    1 hour

Secondary Outcomes (6)

  • Ventilator pressure delivery

    1 hour

  • Ventilator flow delivery

    1 hour

  • Heart rate

    1 hour

  • Oxygen saturation

    1 hour

  • Transcutaneous carbon dioxide tension

    1 hour

  • +1 more secondary outcomes

Study Arms (2)

nCPAP prongs

ACTIVE COMPARATOR
Device: Nasal interface

Infant cannula

ACTIVE COMPARATOR
Device: Nasal interface

Interventions

Nasal interfaceDEVICE

Randomized to initial interface of nCPAP prongs or infant cannula

Also known as: Neotech RAM infant cannula, Miniflow Nasal CPAP Prongs
Infant cannulanCPAP prongs

Eligibility Criteria

AgeUp to 28 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Chronologic age less than 28 days
  • Gestational age at birth between 24 weeks 0 days to 34 weeks 6 days
  • Currently receiving NIPPV, NIV NAVA, or nCPAP

You may not qualify if:

  • Oxygen requirement greater than 40%
  • Peak inspiratory pressure greater than 20 cm H2O
  • Major congenital anomalies of the heart or lungs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

RECRUITING

Related Publications (1)

  • Lynch AL, Matlock DN, Akmyradov C, Weisner MD, Beck J, Sinderby C, Courtney SE. Tidal volume delivery during nasal intermittent positive pressure ventilation: infant cannula vs. nasal continuous positive airway pressure prongs. J Perinatol. 2024 Feb;44(2):244-249. doi: 10.1038/s41372-023-01846-7. Epub 2023 Dec 21.

    PMID: 38129599DERIVED

Central Study Contacts

Ashley Lynch, M.D.

CONTACT

501-412-0988allynch@uams.edu

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
Principle Investigator

Study Record Dates

First Submitted

March 26, 2020

First Posted

March 30, 2020

Study Start

March 7, 2019

Primary Completion

June 30, 2020

Study Completion

June 30, 2020

Last Updated

March 30, 2020

Record last verified: 2020-03

Locations

US(1)