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

Neonatal Respiratory Failure Clinical Trial

— BIPAP  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01318824
• Other study ID #: 2011002
• Status: Active, not recruiting
• Phase: Phase 3
• First received: February 23, 2011
• Last updated: March 22, 2011
• Start date: December 2010
• Est. completion date: February 2013

Study information

• Verified date: January 2011
• Source: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationChina: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: February 2013
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 28 Days

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neonatal Respiratory Failure
• Respiratory Insufficiency

Intervention

Procedure:
• Nasal Intermittent Positive Pressure Ventilation (NIPPV)
The Control group receiving Nasal Intermittent Positive Pressure Ventilation (NIPPV) treatment
• Bi-Level Positive Airway Pressure (BIPAP)
BiPAP group receive Bi-Level Positive Airway Pressure (BIPAP) treatment

Locations

Country	Name	City	State
China	Deaprtment of Pediatrics, Daping Hospital, Third Military Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes