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

Phase 3

• Conditions: Neonatal Respiratory Failure
• Interventions: Procedure: Bi-Level Positive Airway Pressure (BIPAP); Procedure: Nasal Intermittent Positive Pressure Ventilation (NIPPV)

• Registration Number: NCT01318824
• Lead Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Brief Summary

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

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 Timeline

• Study Start: 2010-12
• Status Verified: 2011-01
• Primary Completion: 2011-01
• Study First Submitted: 2011-02-23
• Study First Submitted QC: 2011-03-18
• Study First Posted: 2011-03-21
• Last Update Submitted: 2011-03-22
• Last Update Posted: 2011-03-23
• Study Completion: 2013-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
II=BiPAP	Bi-Level Positive Airway Pressure (BIPAP)	This group receive Bi-Level Positive Airway Pressure (BIPAP) treatment
I=NIPPV	Nasal Intermittent Positive Pressure Ventilation (NIPPV)	This group receiving Nasal Intermittent Positive Pressure Ventilation (NIPPV) treatment.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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	get the effect of Versus Bi-Level Positive Airway Pressure (BIPAP) for Neonatal Respiratory Failure

Trial Locations

Locations (1)

Deaprtment of Pediatrics, Daping Hospital, Third Military Medical University; 🇨🇳 Chongqing, Chongqing, China