Nasal Intermittent Positive Pressure Ventilation In Newborn Infants With Respiratory Distress Syndrome
NCT ID: NCT00780624
Last Updated: 2016-04-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2008-01-31
2012-12-31
Brief Summary
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Detailed Description
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The submitted trial is the first prospective, randomized trial Comparing NIPPV vs nCPAP in newborn infants with respiratory distress syndrome.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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NIPPV
The NIPPV group receiving NIPPV treatment.
NIPPV
Ventilator is Bird VIP.
NIPPV
Ventilator(Bird VIP) is used for NIPPV device. Non-invasive NIPPV is used in the NIPPV group instead of nCPAP in the control group.
NIPPV
Ventilator (Bird VIP, USA) is used for provide of NIPPV in the NIPPV group instead of nCPAP in the control group. The duration of NIPPV is according to the baby's respiratory condition.
Control
The Control group receiving nCPAP treatment.
NIPPV
Ventilator is Bird VIP.
NIPPV
Ventilator(Bird VIP) is used for NIPPV device. Non-invasive NIPPV is used in the NIPPV group instead of nCPAP in the control group.
NIPPV
Ventilator (Bird VIP, USA) is used for provide of NIPPV in the NIPPV group instead of nCPAP in the control group. The duration of NIPPV is according to the baby's respiratory condition.
Interventions
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NIPPV
Ventilator is Bird VIP.
NIPPV
Ventilator(Bird VIP) is used for NIPPV device. Non-invasive NIPPV is used in the NIPPV group instead of nCPAP in the control group.
NIPPV
Ventilator (Bird VIP, USA) is used for provide of NIPPV in the NIPPV group instead of nCPAP in the control group. The duration of NIPPV is according to the baby's respiratory condition.
Eligibility Criteria
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Inclusion Criteria
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
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
1 Minute
28 Days
ALL
No
Sponsors
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Third Military Medical University
OTHER
Responsible Party
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Yuan Shi
Professor and Chief of Pediatrics
Principal Investigators
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Yuan Shi, MD
Role: STUDY_DIRECTOR
Department of Pediatrics, Daping Hospital, Third Military Medical University
Locations
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Deaprtment of Pediatrics, Daping Hospital, Third Military Medical University
Chongqing, Chongqing Municipality, China
Countries
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References
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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.
Other Identifiers
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NCR2008053
Identifier Type: -
Identifier Source: org_study_id
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