Neonatal Respiratory Failure
Conditions
Keywords
Neonatal Respiratory Failure, Newborn Infant, BiPAP, NIPPV
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.
Interventions
The Control group receiving Nasal Intermittent Positive Pressure Ventilation (NIPPV) treatment
PROCEDUREBi-Level Positive Airway Pressure (BIPAP)
BiPAP group receive Bi-Level Positive Airway Pressure (BIPAP) treatment
Sponsors
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
No minimum to 28 Days
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Outcome results
None listed