Recruiting

Infant Cannula vs. CPAP Prongs

Sponsor:

Arkansas Children's Hospital Research Institute

Code:

NCT04326270

Conditions

Respiratory Distress Syndrome in Premature Infant

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Nasal interface

Study Details

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.

Conditions

Respiratory Distress Syndrome in Premature Infant

Study ID

NCT04326270

Start date

Mar 7, 2019

Status verified date

Mar, 2020

Completion date

Jun 30, 2020

Anticipated

Primary completion date

Jun 30, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: nCPAP prongs

active comparator: Infant cannula

Interventions

Nasal interface

Randomized to initial interface of nCPAP prongs or infant cannula

Primary outcome measure

  • Relative tidal volume delivery, breath type I [ Time Frame: 1 hour ]
  • Relative tidal volume delivery, breath type II [ Time Frame: 1 hour ]
  • Relative tidal volume delivery, breath type III [ Time Frame: 1 hour ]

Central Contacts and Locations

Central contacts

Ashley Lynch, M.D.

501-412-0988allynch@uams.edu

Locations

Arkansas Children's Hospital

Recruiting

Little Rock, Arkansas, United States, 72202

Contacts

Ashley Lynch, M.D.

501-412-0988allynch@uams.edu

Principal Investigator:

Ashley L Lynch, M.D.

More Information

Sponsor

Arkansas Children's Hospital Research Institute

Last update posted

Mar 30, 2020

Last verified

Mar, 2020

Keywords

  • nasal intermittent positive pressure ventilation
  • non-invasive ventilation
  • nasal continuous positive airway pressure prongs
  • infant nasal cannula
  • tidal volume

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Arkansas Children's Hospital Research Institute on 2020-03-30.