Extubation Readiness Study in Very Low Birthweight Infants

Stopped early · Not applicable

Conditions studied: Respiratory Distress Syndrome

In brief

The objective of this study is to determine whether use of the spontaneous breathing trial allows for earlier successful extubation of very low birth weight (VLBW) infants who are intubated for \>48 hours and have not yet been successfully extubated (extubated \>7 days).

Key facts

Study ID

NCT01471431

Run by

University of Pennsylvania

People needed

81

Starts

2011-08-01

Expected to finish

2016-04-01

Last updated by the study team

2016-06-07

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Birthweight >500g and<1500g.
• Postmenstrual age <34 weeks
• Mechanically ventilated >48 hours
• Never successfully extubated

You may not qualify if…

• Congenital heart disease (other than patent ductus arteriosus (PDA), patent foramen ovale (PFO), and restrictive ventricular septal defect (VSD)
• Known or suspected airway anomalies
• Severe congenital malformations
• Need to remain intubated for other reasons (i.e. having surgery)
• Has met SBT criteria on previous calendar day (after 48 hrs of ventilation, PIP≤18, PEEP≤6, FiO2≤40%, Rate≤30, PS≤8)

Where it is running

• The Hospital of the University of Pennsylvania — Phialdelphia, Pennsylvania, United States
• Pennsylvania Hospital — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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