Nasal Intermittent Positive Pressure Ventilation in Premature Infants (NIPPV)

This study has been completed.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
McMaster University
ClinicalTrials.gov Identifier:
NCT00433212
First received: February 7, 2007
Last updated: November 4, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Respiratory Insufficiency of Prematurity
Device: nCPAP
Device: NIPPV
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Efficacy and Safety of NIPPV to Increase Survival Without Bronchopulmonary Dysplasia in Extremely Low Birth Weight Infants

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Composite of survival to 36 weeks gestational age, free of moderate-severe bronchopulmonary dysplasia [ Time Frame: 36 weeks gestational age ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • All cause mortality at 36 weeks gestational age [ Time Frame: 36 weeks gestational age ] [ Designated as safety issue: Yes ]
  • All cause mortality before first discharge home [ Time Frame: first discharge home ] [ Designated as safety issue: Yes ]
  • retinopathy of prematurity [ Time Frame: discharge home ] [ Designated as safety issue: Yes ]
  • ultrasonographic evidence of brain injury [ Time Frame: 36 weeks gestional age ] [ Designated as safety issue: Yes ]
  • necrotizing enterocolitis [ Time Frame: 36 weeks gestational age ] [ Designated as safety issue: Yes ]
  • growth [ Time Frame: discharge home ] [ Designated as safety issue: Yes ]
  • time to establish full feeds [ Time Frame: discharge home ] [ Designated as safety issue: Yes ]
  • nosocomial infections [ Time Frame: discharge home ] [ Designated as safety issue: No ]
  • need for re-intubation [ Time Frame: 36 weeks gestational age ] [ Designated as safety issue: Yes ]
  • time on supplemental oxygen [ Time Frame: discharge home ] [ Designated as safety issue: No ]
  • duration of positive pressure respiratory support [ Time Frame: discharge home ] [ Designated as safety issue: Yes ]
  • comparison of synchronized and non-synchronized NIPPV [ Time Frame: discharge home ] [ Designated as safety issue: No ]
  • bronchopulmonary dysplasia [ Time Frame: 36 weeks gestational age ] [ Designated as safety issue: Yes ]
  • air leak syndromes [ Time Frame: 36 weeks gestational age ] [ Designated as safety issue: Yes ]
  • nasal trauma [ Time Frame: discharge home ] [ Designated as safety issue: Yes ]

Enrollment: 1011
Study Start Date: April 2007
Study Completion Date: December 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: NIPPV
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
Other Name: nCPAP

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.

  Eligibility

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

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
  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: NCT00433212

  Hide Study Locations
Locations
United States, California
LAC+USC Medical Center
Los Angeles, California, United States, 90033
United States, District of Columbia
Georgetown University Children's Medical Center
Washington, District of Columbia, United States, 20007
The George Washington University Hospital
Washington, District of Columbia, United States, 20037
United States, Massachusetts
Beth Israel Deaconess Medical Center (BIDMC)
Boston, Massachusetts, United States, 02215
Tufts University Medical Center
Boston, Massachusetts, United States, 02111
United States, New Jersey
Virtua West Jersey Hospital
Voorhees, New Jersey, United States, 08043
United States, New York
SUNY Downstate Medical Center
Brooklyn, New York, United States, 11023
New York Hospital Queens
Brooklyn, New York, United States, 11355
Kings County Hospital
Brooklyn, New York, United States, 11203
Queens Hospital Center
Jamaica, New York, United States, 11432
Brookdale University Hospital & Medical Center
New York, New York, United States, 11212
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794-8111
United States, Pennsylvania
Pennsylvania Hospital/U. of Pennsylvania
Philadelphia, Pennsylvania, United States, 19035
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84158-1289
Austria
LKH Feldkirch
Feldkirch, Austria, 6800
Belgium
CHC St. Vincent
Rocourt, Belgium, B-4000
Canada, Manitoba
St. Boniface General Hospital/University of Manitoba
Winnipeg, Manitoba, Canada, R3E 0L8
Winnipeg Health Sciences Centre
Winnipeg, Manitoba, Canada
Canada, Nova Scotia
IWK Health Centre
Halifax, Nova Scotia, Canada
Canada, Ontario
McMaster University
Hamilton, Ontario, Canada, L8S 4J9
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1
The Ottawa Hospital General Campus
Ottawa, Ontario, Canada, K1H 8L6
Hospital for Sick Children
Toronto, Ontario, Canada
Canada, Saskatchewan
Royal University Hospital
Saskatoon, Saskatchewan, Canada
Ireland
Cork University Maternity Hospital
Wilton, Cork, Ireland
National Maternity Hospital
Dublin, Ireland
Coombe Women's Hospital
Dublin, Ireland
Netherlands
University Medical Center Groningen/Beatrix Children's Hosp
Groningen, Netherlands, 9700 RB
Radbund University Nijmegen Medical Center
Nijmegen, Netherlands
Princess Amalia Dept of Pediatrics, Isala Clinics
Zwolle, Netherlands, 8000 GK
Qatar
Hamad Medical Corporation
Doha, Qatar
Singapore
KK Women's and Children's Hospital
Singapore, Singapore, 229899
Sweden
Karolinska University Hospital/Astrid Lingrenn's Children's Hospital
Stockholm, Sweden, S-171 76
United Kingdom
Royal Maternity Hospital
Belfast, Northern Ireland, United Kingdom, BT12 6BB
University of Leicester
Leicester, United Kingdom, LE1 6TP
St. Mary's Hospital
London, United Kingdom, W2 1NY
Sponsors and Collaborators
McMaster University
Canadian Institutes of Health Research (CIHR)
Investigators
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 General Hospital Research Centre
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
  More Information

Publications:
Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT00433212     History of Changes
Other Study ID Numbers: NTG-2007-NIPPV, CIHR MCT-80246, ISRCTN15233270
Study First Received: February 7, 2007
Last Updated: November 4, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by McMaster University:
prematurity
respiratory insufficiency
non-invasive ventilation
bronchopulmonary dysplasia
hyaline membrane disease

Additional relevant MeSH terms:
Bronchopulmonary Dysplasia
Respiratory Insufficiency
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Respiration Disorders

ClinicalTrials.gov processed this record on July 22, 2014