Extubation Readiness Study in Very Low Birthweight Infants

University of Pennsylvania

Status: Terminated

Conditions: Respiratory Distress Syndrome

Treatments: Other: spontaneous breathing trial

Study type: Interventional

Funder types: Other

Identifiers

NCT01471431

813859

Details and patient eligibility

About

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).

Enrollment: 81 patients

Sex: All

Ages: 48 hours to 14 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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81 participants in 2 patient groups

Spontaneous breathing trial

Experimental group

Description:

The spontaneous breathing trial will determine the extubation readiness of the subject.

Treatment:

Other: spontaneous breathing trial

Usual care

No Intervention group

Description:

Subjects will be extubated using usual care, without the use of the spontaneous breathing trial.