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

Primary Purpose

Respiratory Distress Syndrome

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
NIPPV
NIPPV
NIPPV
Sponsored by
Third Military Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Distress Syndrome focused on measuring RDS, Infant, newborn, NIPPV, CPAP

Eligibility Criteria

1 Minute - 28 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Deaprtment of Pediatrics, Daping Hospital, Third Military Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

NIPPV

Control

Arm Description

The NIPPV group receiving NIPPV treatment.

The Control group receiving nCPAP treatment.

Outcomes

Primary Outcome Measures

Incidence of Mechanical Ventilation via endotracheal tube after non-invasive respiratory support.

Secondary Outcome Measures

Overall clinical outcomes at 7 days, 28 days, and 36 weeks postmenstrual age.

Full Information

First Posted
October 24, 2008
Last Updated
April 20, 2016
Sponsor
Third Military Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT00780624
Brief Title
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

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Third Military Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome
Keywords
RDS, Infant, newborn, NIPPV, CPAP

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NIPPV
Arm Type
Active Comparator
Arm Description
The NIPPV group receiving NIPPV treatment.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
The Control group receiving nCPAP treatment.
Intervention Type
Device
Intervention Name(s)
NIPPV
Intervention Description
Ventilator is Bird VIP.
Intervention Type
Device
Intervention Name(s)
NIPPV
Intervention Description
Ventilator(Bird VIP) is used for NIPPV device. Non-invasive NIPPV is used in the NIPPV group instead of nCPAP in the control group.
Intervention Type
Device
Intervention Name(s)
NIPPV
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of Mechanical Ventilation via endotracheal tube after non-invasive respiratory support.
Time Frame
At 7 days after non-invasive respiratorynsupport.
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Minute
Maximum Age & Unit of Time
28 Days
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuan Shi, MD
Organizational Affiliation
Department of Pediatrics, Daping Hospital, Third Military Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Deaprtment of Pediatrics, Daping Hospital, Third Military Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400042
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
24039148
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.
Results Reference
derived

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

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