Nasal Intermittent Positive Pressure Ventilation In Newborn Infants With Respiratory Distress Syndrome

Third Military Medical University

Status: Completed

Conditions: Respiratory Distress Syndrome

Treatments: Device: NIPPV

Study type: Interventional

Funder types: Other

Identifiers

NCT00780624

NCR2008053

Details and patient eligibility

About

The submitted trial is the first prospective, randomized trial comparing nasal intermittent positive pressure ventilation(NIPPV) vs nCPAP in newborn infants with respiratory distress syndrome.

Full description

Nasal intermittent positive pressure ventilation (NIPPV) is similar to nCPAP, but also gives some breaths, or extra support, to newborn infants through a small tube in the nose. NIPPV is safe and effective, and already in use as an alternate "standard" therapy. Nevertheless, NIPPV has never been used in chinese babies.

The submitted trial is the first prospective, randomized trial Comparing NIPPV vs nCPAP in newborn infants with respiratory distress syndrome.

Enrollment: 100 patients

Sex: All

Ages: 1 minute to 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: 1) 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; 2)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

NIPPV

Active Comparator group

Description:

The NIPPV group receiving NIPPV treatment.

Treatment:

Device: NIPPV

Device: NIPPV

Device: NIPPV

Control

Active Comparator group

Description:

The Control group receiving nCPAP treatment.

Treatment:

Device: NIPPV

Device: NIPPV

Device: NIPPV