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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
ClinicalTrials.gov Identifier:
NCT01318824
First received: February 23, 2011
Last updated: March 22, 2011
Last verified: January 2011

February 23, 2011
March 22, 2011
December 2010
January 2011   (final data collection date for primary outcome measure)
the effect of Non Invasive Positive Pressure Ventilation (NIPPV) for Neonatal Respiratory Failure [ Time Frame: At 7 days, 28 days and at 36 weeks postmenstraul age ] [ Designated as safety issue: Yes ]
get the effect of Non Invasive Positive Pressure Ventilation (NIPPV) for Neonatal Respiratory Failure
Same as current
Complete list of historical versions of study NCT01318824 on ClinicalTrials.gov Archive Site
the effect of Versus Bi-Level Positive Airway Pressure (BIPAP) for Neonatal Respiratory Failure [ Time Frame: At 7 days, 28 days and at 36 weeks postmenstraul age ] [ Designated as safety issue: Yes ]
get the effect of Versus Bi-Level Positive Airway Pressure (BIPAP) for Neonatal Respiratory Failure
Same as current
Not Provided
Not Provided
 
A Study of Bi-Level Positive Airway Pressure (BIPAP) Versus Non Invasive Positive Pressure Ventilation (NIPPV) for Neonatal Respiratory Failure
A Study of Bi-Level Positive Airway Pressure (BIPAP) Versus Non Invasive Positive Pressure Ventilation (NIPPV) for Neonatal Respiratory Failure

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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
Neonatal Respiratory Failure
  • Procedure: Nasal Intermittent Positive Pressure Ventilation (NIPPV)
    The Control group receiving Nasal Intermittent Positive Pressure Ventilation (NIPPV) treatment
    Other Name: Nasal Intermittent Positive Pressure Ventilation
  • Procedure: Bi-Level Positive Airway Pressure (BIPAP)
    BiPAP group receive Bi-Level Positive Airway Pressure (BIPAP) treatment
    Other Name: Bi-Level Positive Airway Pressure
  • Placebo Comparator: I=NIPPV
    This group receiving Nasal Intermittent Positive Pressure Ventilation (NIPPV) treatment.
    Intervention: Procedure: Nasal Intermittent Positive Pressure Ventilation (NIPPV)
  • Experimental: II=BiPAP
    This group receive Bi-Level Positive Airway Pressure (BIPAP) treatment
    Intervention: Procedure: Bi-Level Positive Airway Pressure (BIPAP)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
February 2013
January 2011   (final data collection date for primary outcome measure)

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. 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.
  4. No known lethal congenital anomaly or genetic syndromes.
  5. Signed parental informed consent.

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 an endotracheal tube
Both
up to 28 Days
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01318824
2011002
Yes
Yuan Shi and Shifang Tang, Daping Hospital, Third Military Medical University
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Not Provided
Study Director: Yuan Shi, MD Department of Pediatrics, Daping Hospital, Third Military Medical University
Principal Investigator: Shifang Tang Department of Pediatrics, Daping Hospital, Third Military Medical University
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP