Clinical trial NCT00780624: Nasal Intermittent Positive Pressure Ventilation In Newborn Infants With Respiratory Distress Syndrome
Official title: Nasal Intermittent Positive Pressure Ventilation In Newborn Infants With Respiratory Distress Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Distress Syndrome
Keywords: RDS
Infant, newborn
NIPPV
CPAP
Lead sponsor: Third Military Medical University
Sponsor class: OTHER
First posted: 2008-10-27
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

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: 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

Primary outcomes:
measure: Incidence of Mechanical Ventilation via endotracheal tube after non-invasive respiratory support.
timeFrame: At 7 days after non-invasive respiratorynsupport.
Secondary outcomes:
measure: Overall clinical outcomes at 7 days, 28 days, and 36 weeks postmenstrual age.
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
References:
citation: Shi Y, Tang S, Zhao J, Shen J. A prospective, randomized, controlled study of NIPPV versus nCPAP in preterm and term infants with respiratory distress syndrome. Pediatr Pulmonol. 2014 Jul;49(7):673-8. doi: 10.1002/ppul.22883. Epub 2013 Sep 4.