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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04836689
Other study ID # RMB-0490-20
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2021
Est. completion date September 1, 2022

Study information

Verified date September 2022
Source Rambam Health Care Campus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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/high and switched back to starting rate.


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 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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
nasal intermittent positive pressure ventilation (NIPPV).
NIPPV will be administered using Leoni (Heinen&Löwenstein, Bad Ems, Germany) and RAM cannula (Neotech, Valencia, CA). After initial setting and before routine blood gas testing, tcCO2 will be connected and calibrated. We will use SenTec digital monitor (SenTec AG, Therwil, Switzerland). Correlation/agreement between the tcCO2 and PCO2 will be assessed and documented in each infant. For Each infant we will get 2 set of data: Change in measurements when changing from 30 bpm to 10 bpm, and change in measurements when changing from 10 bpm to 30 bpm At the end of each hour, before rate change, we will document the following measurements:TcCO2, FiO2, saturation, the infant's respiratory rate (as measured in the monitor), number of apneas, bradycardia (heart rate<100 bpm), saturation<90% and>94% episodes (as measured in the monitor), 1-hour saturation histogram clasification.

Locations

Country Name City State
Israel Rambam Medical Center Haifa

Sponsors (1)

Lead Sponsor Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

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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