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Full eligibility criteria for NCT01318824
Ages eligible for Study
up to 28 Days
Genders eligible for Study
Accepts Healthy Volunteers
Newborn infants with birth weight > 500 gm.
Gestational age > 24 completed weeks.
Intention to manage the infant with non-invasive respiratory support (i.e. no endotracheal tube), where either: the infant is within the first 7 days of life and has never been intubated or has received less than 24 hours of total cumulative intubated respiratory support the infant is within the first 28 days of life, has been managed with intubated respiratory support for 24 hours or more and is a candidate for extubation followed by non-invasive respiratory support.
No known lethal congenital anomaly or genetic syndromes.
Signed parental informed consent.
Considered non-viable by clinician (decision not to administer effective therapies)
Infants who are > 28 days old and continue to require mechanical ventilation with an endotracheal tube
All locations for NCT01318824
Deaprtment of Pediatrics, Daping Hospital, Third Military Medical University
Chongqing, Chongqing, China, 400042
View full eligibility
Tris trial is registered with FDA with number: NCT01318824. The sponsor of the trial is Daping Hospital and the Research Institute of Surgery of the Third Military Medical University and it is looking for 100 volunteers for the current phase.
Official trial title: A Study of Bi-Level Positive Airway Pressure (BIPAP) Versus Non Invasive Positive Pressure Ventilation (NIPPV) for Neonatal Respiratory Failure
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