Working… Menu

Nasal Intermittent Positive Pressure Ventilation in Premature Infants (NIPPV) (NIPPV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00433212
Recruitment Status : Completed
First Posted : February 9, 2007
Last Update Posted : December 5, 2014
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
McMaster University

Brief Summary:

The machines and oxygen used to help very premature babies breathe can have side-effects, such as bronchopulmonary dysplasia (BPD). Infants with BPD get more complications (a higher death rate, a longer time in intensive care and on assisted ventilation, more hospital readmissions in the first year of life, and more learning problems) than infants who do not develop BPD. Doctors try to remove the tube in the wind-pipe that links the baby to the breathing machine as soon as possible. However, small babies get tired, and still require help to breathe. One of the standard and common techniques to help them breathe without a tube in the wind-pipe is to use simple pressure support, nasal continuous positive airway pressure or nCPAP. This supports breathing a little, but it is often not enough to prevent the need to go back on the breathing machine.

Nasal intermittent positive pressure ventilation (NIPPV) is similar to nCPAP, but also gives some breaths, or extra support, to babies through a small tube in the nose. NIPPV is safe and effective, and already in use as an alternate "standard" therapy.

The main research question: After being weaned from the breathing machine, is NIPPV better than nCPAP in preventing BPD in premature babies weighing 999 grams or less at birth?

Condition or disease Intervention/treatment Phase
Respiratory Insufficiency of Prematurity Device: nCPAP Device: NIPPV Phase 3

Detailed Description:

The immature lung of extremely low birth weight (ELBW, < 1000 g) infants is easily damaged by the placement of an endotracheal tube to deliver mechanical ventilation and oxygen. This and the total time of mechanical ventilation contributes to bronchopulmonary dysplasia (BPD). Infants with BPD have an increased risk of later death or neuro-impairment. With the increasing survival of ELBW infants in the NICU, there has been a proportionate increase in the number of infants surviving with BPD.

Following invasive ventilation via an endotracheal tube (ETT), extubation to nasal Continuous Positive Airway Pressure (nCPAP)ventilation is the standard approach. Currently, 40% of infants who are extubated and given nCPAP support fail, and require re-intubation. Previous work suggests that a less invasive respiratory support such as Nasal Intermittent Positive Pressure Ventilation (NIPPV), without an endotracheal tube is less injurious to the lung. NIPPV may thereby reduce the duration of invasive ventilator support, and aid successful early extubation. We hypothesize that the use of NIPPV leads to a higher rate of survival without BPD than standard therapy with nCPAP.

This randomized clinical trial is appropriately powered to compare NIPPV with nCPAP to detect effects on clinically relevant long-term outcomes, such as death and BPD at 36 weeks. This is a multi-national, randomized, open clinical trial of two different standard methods of providing non-invasive respiratory support to 1000 extremely preterm infants weighing less than 1000 grams at birth.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1011 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Efficacy and Safety of NIPPV to Increase Survival Without Bronchopulmonary Dysplasia in Extremely Low Birth Weight Infants
Study Start Date : April 2007
Actual Primary Completion Date : August 2011
Actual Study Completion Date : December 2011

Arm Intervention/treatment
Active Comparator: A
Non-invasive respiratory support via nasal intermittent positive pressure ventilation
Device: NIPPV
Deliver non-invasive respiratory support via ventilator with NIPPV device

Active Comparator: B
Non-invasive respiratory support via nasal Continuous Positive Airway Pressure
Device: nCPAP
Deliver non-invasive respiratory support via ventilator with nCPAP device

Primary Outcome Measures :
  1. Composite of survival to 36 weeks gestational age, free of moderate-severe bronchopulmonary dysplasia [ Time Frame: 36 weeks gestational age ]

Secondary Outcome Measures :
  1. All cause mortality at 36 weeks gestational age [ Time Frame: 36 weeks gestational age ]
  2. All cause mortality before first discharge home [ Time Frame: first discharge home ]
  3. retinopathy of prematurity [ Time Frame: discharge home ]
  4. ultrasonographic evidence of brain injury [ Time Frame: 36 weeks gestional age ]
  5. necrotizing enterocolitis [ Time Frame: 36 weeks gestational age ]
  6. growth [ Time Frame: discharge home ]
  7. time to establish full feeds [ Time Frame: discharge home ]
  8. nosocomial infections [ Time Frame: discharge home ]
  9. need for re-intubation [ Time Frame: 36 weeks gestational age ]
  10. time on supplemental oxygen [ Time Frame: discharge home ]
  11. duration of positive pressure respiratory support [ Time Frame: discharge home ]
  12. comparison of synchronized and non-synchronized NIPPV [ Time Frame: discharge home ]
  13. bronchopulmonary dysplasia [ Time Frame: 36 weeks gestational age ]
  14. air leak syndromes [ Time Frame: 36 weeks gestational age ]
  15. nasal trauma [ Time Frame: discharge home ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Birth weight <1000 gm
  • Gestational age <30 completed weeks
  • Intention to manage the infant with non-invasive respiratory support (i.e. no endotracheal tube), where either:

    • 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;
    • 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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00433212

Show Show 35 study locations
Sponsors and Collaborators
McMaster University
Canadian Institutes of Health Research (CIHR)
Layout table for investigator information
Study Chair: Haresh Kirpalani, MD, MSc Hamilton Health Sciences Corporation
Study Director: Brigitte Lemyre, MD Children's Hospital of Eastern Ontario
Study Director: Aaron Chiu, MD St. Boniface Hospital
Study Director: David Millar, MD Royal Maternity Hospital, Belfast
Study Director: Robin S Roberts, MTech Hamilton Health Sciences/McMaster University
Study Director: Bradley Yoder, MD University of Utah
Study Director: Peter H Dijk, MD, PhD University Medical Centrum Groningen
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: McMaster University Identifier: NCT00433212    
Other Study ID Numbers: NTG-2007-NIPPV
CIHR MCT-80246
First Posted: February 9, 2007    Key Record Dates
Last Update Posted: December 5, 2014
Last Verified: December 2014
Keywords provided by McMaster University:
respiratory insufficiency
non-invasive ventilation
bronchopulmonary dysplasia
hyaline membrane disease
Additional relevant MeSH terms:
Layout table for MeSH terms
Bronchopulmonary Dysplasia
Respiratory Insufficiency
Premature Birth
Pulmonary Valve Insufficiency
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Respiration Disorders
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases