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Respiratory Insufficiency of PrematurityPhase 3NIPPVNCT00433212

Nasal Intermittent Positive Pressure Ventilation in Premature Infants (NIPPV)

A Phase 3 study testing nCPAP and NIPPV in people with Respiratory Insufficiency of Prematurity, run by McMaster University at 35 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages Up to 28 days
Conditions the study is for
Respiratory Insufficiency of Prematurity
What is being tested?
nCPAP and NIPPV
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,011 participants
Where
35 sitesin 10 countries
Study dates
Apr 2007to Dec 2011
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 28 days
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

35 sites in 10 countries.

35 sites in 10 countries

United States14 sites

  • Tufts University Medical Center

    Boston, Massachusetts, 02111

  • Beth Israel Deaconess Medical Center (BIDMC)

    Boston, Massachusetts, 02215

  • SUNY Downstate Medical Center

    Brooklyn, New York, 11023

  • Kings County Hospital

    Brooklyn, New York, 11203

  • New York Hospital Queens

    Brooklyn, New York, 11355

  • Queens Hospital Center

    Jamaica, New York, 11432

  • Brookdale University Hospital & Medical Center

    New York, New York, 11212

  • Pennsylvania Hospital/U. of Pennsylvania

    Philadelphia, Pennsylvania, 19035

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

  • University of Utah

    Salt Lake City, Utah, 84158-1289

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794-8111

  • Virtua West Jersey Hospital

    Voorhees Township, New Jersey, 08043

  • Georgetown University Children's Medical Center

    Washington D.C., District of Columbia, 20007

  • The George Washington University Hospital

    Washington D.C., District of Columbia, 20037

Other trials in United States

Canada8 sites

  • IWK Health Centre

    Halifax, Nova Scotia

  • McMaster University

    Hamilton, Ontario, L8S 4J9

  • Children's Hospital of Eastern Ontario

    Ottawa, Ontario, K1H 8L1

  • The Ottawa Hospital General Campus

    Ottawa, Ontario, K1H 8L6

  • Royal University Hospital

    Saskatoon, Saskatchewan

  • Hospital for Sick Children

    Toronto, Ontario

  • St. Boniface General Hospital/University of Manitoba

    Winnipeg, Manitoba, R3E 0L8

  • Winnipeg Health Sciences Centre

    Winnipeg, Manitoba

Other trials in Canada

Ireland3 sites

  • Coombe Women's Hospital

    Dublin

  • National Maternity Hospital

    Dublin

  • Cork University Maternity Hospital

    Wilton, Cork

Other trials in Ireland

United Kingdom3 sites

  • Royal Maternity Hospital

    Belfast, Northern Ireland, BT12 6BB

  • University of Leicester

    Leicester, LE1 6TP

  • St. Mary's Hospital

    London, W2 1NY

Other trials in United Kingdom

Netherlands2 sites

  • University Medical Center Groningen/Beatrix Children's Hosp

    Groningen, 9700 RB

  • Princess Amalia Dept of Pediatrics, Isala Clinics

    Zwolle, 8000 GK

Other trials in Netherlands

Austria1 site

  • LKH Feldkirch

    Feldkirch, 6800

Other trials in Austria

Belgium1 site

  • CHC St. Vincent

    Rocourt, B-4000

Other trials in Belgium

Qatar1 site

  • Hamad Medical Corporation

    Doha

Other trials in Qatar

Singapore1 site

  • KK Women's and Children's Hospital

    Singapore, 229899

Other trials in Singapore

Sweden1 site

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

    Stockholm, S-171 76

Other trials in Sweden

About this study

Official title: Efficacy and Safety of NIPPV to Increase Survival Without Bronchopulmonary Dysplasia in Extremely Low Birth Weight Infants

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?

Read the 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.

Being tested
nCPAP, NIPPV
Keywords
prematurity, respiratory insufficiency, non-invasive ventilation, bronchopulmonary dysplasia, hyaline membrane disease
Medical subject headings
Respiratory Insufficiency, Premature Birth, Bronchopulmonary Dysplasia, Hyaline Membrane Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • nCPAPDevice

    Deliver non-invasive respiratory support via ventilator with nCPAP device

  • NIPPVDevice

    Deliver non-invasive respiratory support via ventilator with NIPPV device

Study groups in NCT00433212
Study groupRoleWhat they receive
AActive comparatorNon-invasive respiratory support via nasal intermittent positive pressure ventilation
Receives: Device: NIPPV
BActive comparatorNon-invasive respiratory support via nasal Continuous Positive Airway Pressure
Receives: Device: nCPAP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite of survival to 36 weeks gestational age, free of moderate-severe bronchopulmonary dysplasia

    Measured: 36 weeks gestational age

Secondary outcomes (15)

  1. All cause mortality at 36 weeks gestational age

    Measured: 36 weeks gestational age

  2. All cause mortality before first discharge home

    Measured: first discharge home

  3. retinopathy of prematurity

    Measured: discharge home

  4. ultrasonographic evidence of brain injury

    Measured: 36 weeks gestional age

  5. necrotizing enterocolitis

    Measured: 36 weeks gestational age

  6. growth

    Measured: discharge home

  7. time to establish full feeds

    Measured: discharge home

  8. nosocomial infections

    Measured: discharge home

  9. need for re-intubation

    Measured: 36 weeks gestational age

  10. time on supplemental oxygen

    Measured: discharge home

  11. duration of positive pressure respiratory support

    Measured: discharge home

  12. comparison of synchronized and non-synchronized NIPPV

    Measured: discharge home

  13. bronchopulmonary dysplasia

    Measured: 36 weeks gestational age

  14. air leak syndromes

    Measured: 36 weeks gestational age

  15. nasal trauma

    Measured: discharge home

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2007 (estimated)
  2. Study startApr 2007
  3. Primary completionAug 2011
  4. Study completionDec 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,011 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00433212
Sponsor's protocol ID
NTG-2007-NIPPV
Other IDs
CIHR MCT-80246, ISRCTN15233270
Acronym
NIPPV
Status last verified
Dec 2014
First submitted
7 Feb 2007
Last updated
5 Dec 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Kirpalani H, Millar D, Lemyre B, Yoder BA, Chiu A, Roberts RS; NIPPV Study Group. A trial comparing noninvasive ventilation strategies in preterm infants. N Engl J Med. 2013 Aug 15;369(7):611-20. doi: 10.1056/NEJMoa1214533.

    PubMed 23944299

  • Bamat NA, Guevara JP, Bryan M, Roberts RS, Yoder BA, Lemyre B, Chiu A, Millar D, Kirpalani H. Variation in Positive End-Expiratory Pressure Levels for Mechanically Ventilated Extremely Low Birth Weight Infants. J Pediatr. 2018 Mar;194:28-33.e5. doi: 10.1016/j.jpeds.2017.10.065. Epub 2017 Dec 22.

    PubMed 29275926

  • Millar D, Lemyre B, Kirpalani H, Chiu A, Yoder BA, Roberts RS. A comparison of bilevel and ventilator-delivered non-invasive respiratory support. Arch Dis Child Fetal Neonatal Ed. 2016 Jan;101(1):F21-5. doi: 10.1136/archdischild-2014-308123. Epub 2015 Jul 10.

    PubMed 26162889

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing nCPAP and NIPPV in people with Respiratory Insufficiency of Prematurity, run by McMaster University at 35 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in United States, Canada, Ireland, United Kingdom, Netherlands and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite of survival to 36 weeks gestational age, free of moderate-severe bronchopulmonary dysplasia (time frame: 36 weeks gestational age). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00433212, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2014.

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