Changes of the right diaphragmatic kinetics following tracheal extubation in the newborn by using pulsed tissue Doppler imaging: a pilot study. (ET RD-PTDI neo)

Study identification

• EU PAS number:
  EUPAS107663
• Study ID:
  108118
• Official title and acronym:
  Changes of the right diaphragmatic kinetics following tracheal extubation in the newborn by using pulsed tissue Doppler imaging: a pilot study. (ET RD-PTDI neo)
• DARWIN EU® study:
  No
• Study countries:
  Italy
• Study description:
  This is an observational, non-interventional cohort pilot study. Our objective is to describe potential changes in right diaphragm kinetics, if any, using pulsed-wave tissue Doppler imaging after extubation and withdrawal of mechanical ventilation in the newborn. The results of this pilot study will provide indications for a subsequent study in case of changes in diaphragmatic kinetics predictive of extubation failure (defined as the need to restore mechanical ventilation within 72 hours of extubation due to respiratory failure), for validation in an adequate sample of newborns.
• Study status:
  Ongoing

Study timelines

Date when funding contract was signed

Planned:15/11/2023

Study start date

Planned:15/11/2023

Actual:11/12/2023

Date of final study report

Planned:11/11/2024

Sources of funding

Other

More details on funding

No funding

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable