Nasal Intermittent Positive Pressure Ventilation In Newborn Infants With Respiratory Distress Syndrome - Full Text View

Sponsored by:	Third Military Medical University
Information provided by:	Third Military Medical University
ClinicalTrials.gov Identifier:	NCT00780624

Purpose

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.

Condition	Intervention	Phase
Respiratory Distress Syndrome Newborn	Device: NIPPV	Phase I Phase II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Nasal Intermittent Positive Pressure Ventilation In Newborn Infants With Respiratory Distress Syndrome

Further study details as provided by Third Military Medical University:

Primary Outcome Measures:

Incidence of Mechanical Ventilation via endotracheal tube after non-invasive respiratory support. [ Time Frame: At 7 days after non-invasive respiratorynsupport. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall clinical outcomes at 7 days, 28 days, and 36 weeks postmenstrual age. [ Time Frame: At 7 days, 28 days and at 36 weeks postmenstraul age ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	January 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
NIPPV: Active Comparator The NIPPV group receiving NIPPV treatment.	Device: NIPPV Ventilator is Bird VIP. Device: 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. Device: 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: Active Comparator The Control group receiving nCPAP treatment.	Device: NIPPV Ventilator is Bird VIP. Device: 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. Device: 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.

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

Ages Eligible for Study:	up to 28 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Newborn infants with birth weight >500 gm.
Gestational age >24 completed weeks.
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.
No known lethal congenital anomaly or genetic syndromes.
Signed parental informed consent.

Exclusion Criteria:

Considered non-viable by clinician (decision not to administer effective therapies)
Life-threatening congenital abnormalities including congenital heart disease (excluding patent ductus arteriosis)
Infants known to require surgical treatment
Abnormalities of the upper and lower airways
Neuromuscular disorders
Infants who are >28 days old and continue to require mechanical ventilation with an endotracheal tube

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00780624

Contacts

Contact: Yuan Shi, MD

+86 23 68757731

petshi530@vip.163.com

Locations

China
Deaprtment of Pediatrics, Daping Hospital, Third Military Medical University	Recruiting
Chongqing, China, 400042
Contact: Yuan Shi, MD +86 23 68757731 petshi530@vip.163.com
Principal Investigator: Shifang Tang, MSc

Sponsors and Collaborators

Third Military Medical University

Investigators

Study Director:

Yuan Shi, MD

Department of Pediatrics, Daping Hospital, Third Military Medical University

More Information

No publications provided

Responsible Party:	Department of Medicine ( Daping Hospital, Third Military Medical University )
Study ID Numbers:	NCR2008053
Study First Received:	October 24, 2008
Last Updated:	October 24, 2008
ClinicalTrials.gov Identifier:	NCT00780624 History of Changes
Health Authority:	China:The Committee of Clinical Research of Daping Hospital, Third Military Medical University

Keywords provided by Third Military Medical University:

RDS
Infant, newborn
NIPPV
CPAP

Study placed in the following topic categories:

Respiratory Tract Diseases
Lung Diseases
Respiration Disorders
Respiratory Distress Syndrome, Adult
Acute Respiratory Distress Syndrome

Additional relevant MeSH terms:

Pathologic Processes
Disease
Respiratory Tract Diseases
Lung Diseases

Syndrome
Respiration Disorders
Respiratory Distress Syndrome, Adult

ClinicalTrials.gov processed this record on May 07, 2009