Ventilator Lung; Newborn Clinical Trial
Official title:
Influence of Respiratory Rate Settings on CO2 Levels During Nasal Intermittent Positive Pressure Ventilation (NIPPV).
Verified date | September 2022 |
Source | Rambam Health Care Campus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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/high and switched back to starting rate.
Status | Completed |
Enrollment | 50 |
Est. completion date | September 1, 2022 |
Est. primary completion date | August 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 1 Month |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Israel | Rambam Medical Center | Haifa |
Lead Sponsor | Collaborator |
---|---|
Rambam Health Care Campus |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Trans cutaneous CO2 (TCCO2) | Trans cutaneous CO2 | During the 3 hours of the study |
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