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

Army Medical University of People's Liberation Army

Status and phase: Unknown; Phase 3

Conditions: Neonatal Respiratory Failure

Treatments: Procedure: Bi-Level Positive Airway Pressure (BIPAP); Procedure: Nasal Intermittent Positive Pressure Ventilation (NIPPV)

Study type: Interventional

Funder types: Other

Identifiers

NCT01318824

2011002

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: Under 28 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups, including a placebo group

I=NIPPV

Placebo Comparator group

Description:

This group receiving Nasal Intermittent Positive Pressure Ventilation (NIPPV) treatment.

Treatment:

Procedure: Nasal Intermittent Positive Pressure Ventilation (NIPPV)

II=BiPAP

Experimental group

Description:

This group receive Bi-Level Positive Airway Pressure (BIPAP) treatment

Treatment:

Procedure: Bi-Level Positive Airway Pressure (BIPAP)