Nasal Intermittent Positive Pressure Ventilation in Premature Infants (NIPPV)

NCT00433212 | Completed Phase 3 DMC

• 3 other identifiers: NTG-2007-NIPPVCIHR MCT-80246ISRCTN15233270
• Study Type: interventional
• Target: 1,011
• Locations: 10 countries
• Sites: 35

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?

Conditions

Respiratory Insufficiency of Prematurity

Keywords

prematurity; respiratory insufficiency; non-invasive ventilation; bronchopulmonary dysplasia; hyaline membrane disease

Outcome Measures

Primary Outcomes (1)

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

  36 weeks gestational age

Secondary Outcomes (15)

• All cause mortality at 36 weeks gestational age

  36 weeks gestational age

• All cause mortality before first discharge home

  first discharge home

• retinopathy of prematurity

  discharge home

• ultrasonographic evidence of brain injury

  36 weeks gestional age

• necrotizing enterocolitis

  36 weeks gestational age

Study Arms (2)

A

ACTIVE COMPARATOR

Non-invasive respiratory support via nasal intermittent positive pressure ventilation

Device: NIPPV

B

ACTIVE COMPARATOR

Non-invasive respiratory support via nasal Continuous Positive Airway Pressure

Device: nCPAP

Interventions

nCPAP DEVICE

Deliver non-invasive respiratory support via ventilator with nCPAP device

B

NIPPV DEVICE

Deliver non-invasive respiratory support via ventilator with NIPPV device

A

Eligibility Criteria

• Age: Up to 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (35)

Georgetown University Children's Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

The George Washington University Hospital

Washington D.C., District of Columbia, 20037, United States

Location

Tufts University Medical Center

Boston, Massachusetts, 02111, United States

Location

Beth Israel Deaconess Medical Center (BIDMC)

Boston, Massachusetts, 02215, United States

Location

Virtua West Jersey Hospital

Voorhees Township, New Jersey, 08043, United States

Location

SUNY Downstate Medical Center

Brooklyn, New York, 11023, United States

Location

Kings County Hospital

Brooklyn, New York, 11203, United States

Location

New York Hospital Queens

Brooklyn, New York, 11355, United States

Location

Queens Hospital Center

Jamaica, New York, 11432, United States

Location

Brookdale University Hospital & Medical Center

New York, New York, 11212, United States

Location

Stony Brook University Medical Center

Stony Brook, New York, 11794-8111, United States

Location

Pennsylvania Hospital/U. of Pennsylvania

Philadelphia, Pennsylvania, 19035, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

University of Utah

Salt Lake City, Utah, 84158-1289, United States

Location

LKH Feldkirch

Feldkirch, 6800, Austria

Location

CHC St. Vincent

Rocourt, B-4000, Belgium

Location

St. Boniface General Hospital/University of Manitoba

Winnipeg, Manitoba, R3E 0L8, Canada

Location

Winnipeg Health Sciences Centre

Winnipeg, Manitoba, Canada

Location

IWK Health Centre

Halifax, Nova Scotia, Canada

Location

McMaster University

Hamilton, Ontario, L8S 4J9, Canada

Location

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

The Ottawa Hospital General Campus

Ottawa, Ontario, K1H 8L6, Canada

Location

Hospital for Sick Children

Toronto, Ontario, Canada

Location

Royal University Hospital

Saskatoon, Saskatchewan, Canada

Location

Cork University Maternity Hospital

Wilton, Cork, Ireland

Location

Coombe Women's Hospital

Dublin, Ireland

Location

National Maternity Hospital

Dublin, Ireland

Location

University Medical Center Groningen/Beatrix Children's Hosp

Groningen, 9700 RB, Netherlands

Location

Princess Amalia Dept of Pediatrics, Isala Clinics

Zwolle, 8000 GK, Netherlands

Location

Hamad Medical Corporation

Doha, Qatar

Location

KK Women's and Children's Hospital

Singapore, 229899, Singapore

Location

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

Stockholm, S-171 76, Sweden

Location

Royal Maternity Hospital

Belfast, Northern Ireland, BT12 6BB, United Kingdom

Location

University of Leicester

Leicester, LE1 6TP, United Kingdom

Location

St. Mary's Hospital

London, W2 1NY, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 23944299 RESULT

• 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.

  PMID: 29275926 DERIVED

• 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.

  PMID: 26162889 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency; Premature Birth; Bronchopulmonary Dysplasia; Hyaline Membrane Disease

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Respiratory Distress Syndrome, Newborn; Respiratory Distress Syndrome

Study Officials

• Haresh Kirpalani, MD, MSc

  Hamilton Health Sciences Corporation

  STUDY CHAIR

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2007
• First Posted: February 9, 2007
• Study Start: April 1, 2007
• Primary Completion: August 1, 2011
• Study Completion: December 1, 2011
• Last Updated: December 5, 2014

Record last verified: 2014-12

Locations

SE (1); AU (1); US (14); CA (8); BE (1); QA (1); IE (3); NL (2); GB (3); SG (1)