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

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

Study Overview

• Status: Unknown
• Conditions: Neonatal Respiratory Failure
• Intervention / Treatment: Procedure: Nasal Intermittent Positive Pressure Ventilation (NIPPV); Procedure: Bi-Level Positive Airway Pressure (BIPAP)

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400042
      • Deaprtment of Pediatrics, Daping Hospital, Third Military Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: I=NIPPV; This group receiving Nasal Intermittent Positive Pressure Ventilation (NIPPV) treatment.	Procedure: Nasal Intermittent Positive Pressure Ventilation (NIPPV); The Control group receiving Nasal Intermittent Positive Pressure Ventilation (NIPPV) treatment; Other Names: Nasal Intermittent Positive Pressure Ventilation
Experimental: II=BiPAP; This group receive Bi-Level Positive Airway Pressure (BIPAP) treatment	Procedure: Bi-Level Positive Airway Pressure (BIPAP); BiPAP group receive Bi-Level Positive Airway Pressure (BIPAP) treatment; Other Names: Bi-Level Positive Airway Pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the effect of Non Invasive Positive Pressure Ventilation (NIPPV) for Neonatal Respiratory Failure	get the effect of Non Invasive Positive Pressure Ventilation (NIPPV) for Neonatal Respiratory Failure	At 7 days, 28 days and at 36 weeks postmenstraul age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the effect of Versus Bi-Level Positive Airway Pressure (BIPAP) for Neonatal Respiratory Failure	get the effect of Versus Bi-Level Positive Airway Pressure (BIPAP) for Neonatal Respiratory Failure	At 7 days, 28 days and at 36 weeks postmenstraul age

Collaborators and Investigators

• Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
• Investigators: 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

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): January 1, 2011
• Study Completion (Anticipated): February 1, 2013

Study Registration Dates

• First Submitted: February 23, 2011
• First Submitted That Met QC Criteria: March 18, 2011
• First Posted (Estimate): March 21, 2011

Study Record Updates

• Last Update Posted (Estimate): March 23, 2011
• Last Update Submitted That Met QC Criteria: March 22, 2011
• Last Verified: January 1, 2011

More Information

Terms related to this study

• Keywords: BiPAP; Newborn Infant; NIPPV; Neonatal Respiratory Failure
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: 2011002