Clinical trial NCT01318824: A Study of Bi-Level Positive Airway Pressure (BIPAP) Versus Non Invasive Positive Pressure Ventilation (NIPPV) for Neonatal Respiratory Failure
Official title: A Study of Bi-Level Positive Airway Pressure (BIPAP) Versus Non Invasive Positive Pressure Ventilation (NIPPV) for Neonatal Respiratory Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Neonatal Respiratory Failure
Keywords: Neonatal Respiratory Failure
Newborn Infant
BiPAP
NIPPV
Lead sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Sponsor class: OTHER
First posted: 2011-03-21
Enrollment: 100
Sex: ALL
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: the effect of Non Invasive Positive Pressure Ventilation (NIPPV) for Neonatal Respiratory Failure
timeFrame: At 7 days, 28 days and at 36 weeks postmenstraul age
Secondary outcomes:
measure: the effect of Versus Bi-Level Positive Airway Pressure (BIPAP) for Neonatal Respiratory Failure
timeFrame: At 7 days, 28 days and at 36 weeks postmenstraul age
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Deaprtment of Pediatrics, Daping Hospital, Third Military Medical University
state: Chongqing
Study officials:
affiliation: Department of Pediatrics, Daping Hospital, Third Military Medical University
name: Yuan Shi, MD
role: STUDY_DIRECTOR
affiliation: Department of Pediatrics, Daping Hospital, Third Military Medical University
name: Shifang Tang
role: PRINCIPAL_INVESTIGATOR
References: