Status:
COMPLETED
Influence of Respiratory Rate Settings on CO2 Levels During Nasal Intermittent Positive Pressure Ventilation (NIPPV).
Lead Sponsor:
Rambam Health Care Campus
Conditions:
Ventilator Lung; Newborn
Eligibility:
All Genders
Up to 1 years
Phase:
NA
Brief Summary
Infants will be monitored by TcCO2 during three consecutive time periods of one hour each on a high and low rate of NIPPV, when in a stable condition. NIPPV rate will start high/low, changed to low/hi...
Detailed Description
This will be a prospective, crossover observational study that will be performed at Rambam NICU. Infants will be monitored by TcCO2 during three consecutive time periods of one hour each on a high an...
Eligibility Criteria
Inclusion
- Gestational age 240 to 336.
- At least 6 hours of stabilized NIPPV settings, i.e. minor changes in settings (FiO2 ≤0.10, PIP≤ 2.0 cmH2O, RR≤ 5 brm).
- At least 6 hours of stabilized tcCO2, i.e. ≤5 mmHg variation.
- At least 6 hours from surfactant administration.
- Parental consent
Exclusion
- If NIPPV set rate is 10 bpm and tcCO2 related pCO2 is\<40mmHg.
- If NIPPV set rate is 30 bpm and tcCO2 related pCO2 is\>60mmHg.
- Unstable infants due to acute conditions (sepsis. IVH), or congenital malformations.
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04836689
Start Date
April 1 2021
End Date
September 1 2022
Last Update
September 22 2022
Active Locations (1)
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1
Rambam Medical Center
Haifa, Israel, 31096