Nasal Intermittent Positive Pressure Ventilation In Newborn Infants With Respiratory Distress Syndrome

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Third Military Medical University
Sponsor:
Information provided by (Responsible Party):
Yuan Shi, Third Military Medical University
ClinicalTrials.gov Identifier:
NCT00780624
First received: October 24, 2008
Last updated: December 17, 2012
Last verified: December 2012
  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
Respiratory Distress Syndrome
Newborn
Device: NIPPV

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
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 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: NIPPV
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.
Active Comparator: Control
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:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Chongqing
Deaprtment of Pediatrics, Daping Hospital, Third Military Medical University Recruiting
Chongqing, 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: Yuan Shi, Professor and Chief of Pediatrics, Third Military Medical University
ClinicalTrials.gov Identifier: NCT00780624     History of Changes
Other Study ID Numbers: NCR2008053
Study First Received: October 24, 2008
Last Updated: December 17, 2012
Health Authority: China: Ethics Committee

Keywords provided by Third Military Medical University:
RDS
Infant, newborn
NIPPV
CPAP

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on July 23, 2014