Nasal Intermittent Positive Pressure Ventilation in Premature Infants (NIPPV)

Last updated: December 3, 2014
Sponsor: McMaster University
Overall Status: Completed

Phase

3

Condition

Respiratory Failure

Lung Disease

Lung Injury

Treatment

N/A

Clinical Study ID

NCT00433212
NTG-2007-NIPPV
CIHR MCT-80246
ISRCTN15233270
  • Ages < 28
  • All Genders

Study 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?

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Birth weight <1000 gm

  • Gestational age <30 completed weeks

  • Intention to manage the infant with non-invasive respiratory support (i.e. noendotracheal tube), where either:

  • the infant is within the first 7 days of life and has never been intubated or hasreceived less than 24 hours of total cumulative intubated respiratory support;

  • the infant is within the first 28 days of life, has been managed with intubatedrespiratory support for 24 hours or more and is a candidate for extubationfollowed by non-invasive respiratory support.

Exclusion

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 anendotracheal tube

Study Design

Total Participants: 1011
Study Start date:
April 01, 2007
Estimated Completion Date:
December 31, 2011

Study 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.

Connect with a study center

  • LKH Feldkirch

    Feldkirch, 6800
    Austria

    Site Not Available

  • CHC St. Vincent

    Rocourt, B-4000
    Belgium

    Site Not Available

  • St. Boniface General Hospital/University of Manitoba

    Winnipeg, Manitoba R3E 0L8
    Canada

    Site Not Available

  • Winnipeg Health Sciences Centre

    Winnipeg, Manitoba
    Canada

    Site Not Available

  • IWK Health Centre

    Halifax, Nova Scotia
    Canada

    Site Not Available

  • McMaster University

    Hamilton, Ontario L8S 4J9
    Canada

    Site Not Available

  • Children's Hospital of Eastern Ontario

    Ottawa, Ontario K1H 8L1
    Canada

    Site Not Available

  • The Ottawa Hospital General Campus

    Ottawa, Ontario K1H 8L6
    Canada

    Site Not Available

  • Hospital for Sick Children

    Toronto, Ontario
    Canada

    Site Not Available

  • Royal University Hospital

    Saskatoon, Saskatchewan
    Canada

    Site Not Available

  • Cork University Maternity Hospital

    Wilton, Cork
    Ireland

    Site Not Available

  • Coombe Women's Hospital

    Dublin,
    Ireland

    Site Not Available

  • National Maternity Hospital

    Dublin,
    Ireland

    Site Not Available

  • University Medical Center Groningen/Beatrix Children's Hosp

    Groningen, 9700 RB
    Netherlands

    Site Not Available

  • Radbund University Nijmegen Medical Center

    Nijmegen,
    Netherlands

    Site Not Available

  • Princess Amalia Dept of Pediatrics, Isala Clinics

    Zwolle, 8000 GK
    Netherlands

    Site Not Available

  • Hamad Medical Corporation

    Doha,
    Qatar

    Site Not Available

  • KK Women's and Children's Hospital

    Singapore, 229899
    Singapore

    Site Not Available

  • Karolinska University Hospital/Astrid Lingrenn's Children's Hospital

    Stockholm, S-171 76
    Sweden

    Site Not Available

  • Royal Maternity Hospital

    Belfast, Northern Ireland BT12 6BB
    United Kingdom

    Site Not Available

  • University of Leicester

    Leicester, LE1 6TP
    United Kingdom

    Site Not Available

  • St. Mary's Hospital

    London, W2 1NY
    United Kingdom

    Site Not Available

  • LAC+USC Medical Center

    Los Angeles, California 90033
    United States

    Site Not Available

  • Georgetown University Children's Medical Center

    Washington, District of Columbia 20007
    United States

    Site Not Available

  • The George Washington University Hospital

    Washington, District of Columbia 20037
    United States

    Site Not Available

  • Beth Israel Deaconess Medical Center (BIDMC)

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Tufts University Medical Center

    Boston, Massachusetts 02111
    United States

    Site Not Available

  • Virtua West Jersey Hospital

    Voorhees, New Jersey 08043
    United States

    Site Not Available

  • Kings County Hospital

    Brooklyn, New York 11203
    United States

    Site Not Available

  • New York Hospital Queens

    Brooklyn, New York 11355
    United States

    Site Not Available

  • SUNY Downstate Medical Center

    Brooklyn, New York 11023
    United States

    Site Not Available

  • Queens Hospital Center

    Jamaica, New York 11432
    United States

    Site Not Available

  • Brookdale University Hospital & Medical Center

    New York, New York 11212
    United States

    Site Not Available

  • Stony Brook University Medical Center

    Stony Brook, New York 11794-8111
    United States

    Site Not Available

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Pennsylvania Hospital/U. of Pennsylvania

    Philadelphia, Pennsylvania 19035
    United States

    Site Not Available

  • University of Utah

    Salt Lake City, Utah 84158-1289
    United States

    Site Not Available

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