Status:
COMPLETED
sNIPPV Versus NIV-NAVA in Extremely Premature Infants
Lead Sponsor:
Centre Hospitalier Intercommunal Creteil
Conditions:
Premature Birth
Ventilator Lung; Newborn
Eligibility:
All Genders
3+ years
Phase:
NA
Brief Summary
The aim of this study is to demonstrate a significant decrease in asynchrony with NIV-NAVA using the Servo n ventilator (Getinge, Sweden), as compared to abdominal triggered (Graseby capsule) synchron...
Detailed Description
The use of non-invasive ventilation has significantly reduced morbidity and mortality in premature newborns by reducing the pulmonary lesions caused by invasive ventilation. Currently, variable flow c...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Premature infants born before 28 weeks of gestation
- Corrected age below 32 weeks of gestation
- Postnatal age \> or = 3 days
- Receiving NIPPV (any mode)
- Equipped with an Edi catheter
- Receiving caffein treatment
- Parental consent
- Recipient of French social security coverage
- Non-inclusion criteria:
- More than 1 apnea/hour requiring bag-mask ventilation, or pH\<7.2 and/or TcPCO2\>70, or FiO2\>0.6 in the previous 6 hours.
- Nasal trauma precluding the use of non-invasive ventilation
- Major congenital anomalies
- Grade III or higher intraventricular hemorrhage
- Use of anesthetics or sedative within the past 24 hours, except opioids for iatrogenic withdrawal treatment
- Hemodynamic compromise defined as a mean blood pressure less than gestational age (in mmHg) or a capillary refill time more than 3 seconds
- Neuro-muscular disorders
Exclusion
Key Trial Info
Start Date :
December 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 11 2021
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04068558
Start Date
December 9 2019
End Date
March 11 2021
Last Update
June 8 2021
Active Locations (1)
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1
Centre Hospitalier Intercommunal de Créteil
Créteil, France, 94000