A Study of Bi-Level Positive Airway Pressure (BIPAP) Versus Non Invasive Positive Pressure Ventilation (NIPPV) for Neonatal Respiratory Failure

Last updated: March 22, 2011
Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Overall Status: Trial Status Unknown

Phase

3

Condition

Respiratory Failure

Lung Injury

Treatment

N/A

Clinical Study ID

NCT01318824
2011002
  • Ages < 28
  • All Genders

Study Summary

To research the effect of Bi-Level Positive Airway Pressure (BiPAP) for neonatal respiratory failure.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Newborn infants with birth weight > 500 gm.

  2. Gestational age > 24 completed weeks.

  3. Intention to manage the infant with non-invasive respiratory support (i.e. noendotracheal tube), where either: the infant is within the first 7 days of life andhas never been intubated or has received less than 24 hours of total cumulativeintubated respiratory support the infant is within the first 28 days of life, has beenmanaged with intubated respiratory support for 24 hours or more and is a candidate forextubation followed by non-invasive respiratory support.

  4. No known lethal congenital anomaly or genetic syndromes.

  5. Signed parental informed consent.

Exclusion

Exclusion Criteria:

  1. Considered non-viable by clinician (decision not to administer effective therapies)

  2. Life-threatening congenital abnormalities including congenital heart disease (excluding patent ductus arteriosis)

  3. Infants known to require surgical treatment

  4. Abnormalities of the upper and lower airways

  5. Neuromuscular disorders

  6. Infants who are > 28 days old and continue to require mechanical ventilation with anendotracheal tube

Study Design

Total Participants: 100
Study Start date:
December 01, 2010
Estimated Completion Date:
February 28, 2013

Study Description

Bi-Level Positive Airway Pressure(BiPAP) is similar to Non Invasive Positive Pressure Ventilation (NIPPV), but also gives some breaths, or extra support, to newborn infants through a small tube in the nose. BiPAP is safe and effective. Nevertheless, BiPAP has never been used in Chinese babies.

Connect with a study center

  • Deaprtment of Pediatrics, Daping Hospital, Third Military Medical University

    Chongqing, Chongqing 400042
    China

    Site Not Available

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