Status:

UNKNOWN

Crossover Comparison of Tidal Volume Delivery During Nasal Intermittent Positive Pressure Ventilation in Preterm Infants: Infant Cannula vs. Nasal Continuous Positive Airway Pressure Prongs

Lead Sponsor:

Arkansas Children's Hospital Research Institute

Conditions:

Respiratory Distress Syndrome in Premature Infant

Eligibility:

All Genders

Up to 28 years

Phase:

NA

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 conti...

Detailed Description

Bedside crossover study of neonates with mild respiratory distress receiving NIPPV. Infants serve as their own controls and are randomized to initial interface of either RAM® infant cannula or Miniflo...

Eligibility Criteria

Inclusion

  • 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

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

Key Trial Info

Start Date :

March 7 2019

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 30 2020

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT04326270

Start Date

March 7 2019

End Date

June 30 2020

Last Update

March 30 2020

Active Locations (1)

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1

Arkansas Children's Hospital

Little Rock, Arkansas, United States, 72202