Status:

COMPLETED

A Comparison of Methods of Discontinuing Nasal CPAP in Premature Infants <30 Weeks Gestation

Lead Sponsor:

The University of Texas Health Science Center, Houston

Conditions:

Apnea of Prematurity

Respiratory Distress Syndrome

Eligibility:

All Genders

Phase:

NA

Brief Summary

The purpose of this study is to determine if among infants \<30 weeks gestational age on nasal continuous positive airway pressure (NCPAP), whether discontinuing CPAP after gradual reduction in contin...

Eligibility Criteria

Inclusion

  • All infants \< 30 weeks by dates, on NCPAP therapy, on caffeine 10mg/kg daily
  • Meet CPAP stability criteria for ≥ 12hours (CPAP 6 cm water (H2O), FiO2 \</=0.25 and stable (to maintain sats 85-95%), Respiratory rate consistently less than 60, Mild to no subcostal/intercostal retractions, No Apnea or bradycardia event that requires bag mask ventilation, Less than 3 apnea/brady/desat episodes in any 1 hour period for previous 6 hours, Tolerated time off CPAP during routine CPAP care (\~15 min)

Exclusion

  • Major congenital anomalies including congenital heart disease
  • Anomalies that prevent discontinuation of NCPAP
  • Undergoing current evaluation for and/or treatment of sepsis

Key Trial Info

Start Date :

September 19 2017

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 31 2019

Estimated Enrollment :

66 Patients enrolled

Trial Details

Trial ID

NCT03292562

Start Date

September 19 2017

End Date

March 31 2019

Last Update

March 17 2020

Active Locations (1)

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The University of Texas Health Science Center at Houston

Houston, Texas, United States, 77030