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: September 16, 2014
Last verified: September 2014

February 7, 2007
September 16, 2014
April 2007
August 2011   (final data collection date for primary outcome measure)
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 ]
Composite of survival to 36 weeks gestational age, free of moderate-severe bronchopulmonary dysplasia
Complete list of historical versions of study NCT00433212 on ClinicalTrials.gov Archive Site
  • 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 ]
  • All cause mortality at 36 weeks gestational age
  • All cause mortality before first discharge home
  • General neonatal morbidities such as:
  • retinopathy of prematurity
  • ultrasonographic evidence of brain injury
  • necrotizing enterocolitis
  • growth
  • time to establish full feeds
  • nosocomial infections
  • Specific respiratory support outcomes:
  • need for re-intubation
  • time on supplemental oxygen
  • duration of positive pressure respiratory support
  • comparison of synchronized and non-synchronized NIPPV
  • bronchopulmonary dysplasia
  • air leak syndromes
  • nasal trauma
Not Provided
Not Provided
 
Nasal Intermittent Positive Pressure Ventilation in Premature Infants (NIPPV)
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?

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Respiratory Insufficiency of Prematurity
  • Device: nCPAP
    Deliver non-invasive respiratory support via ventilator with nCPAP device
    Other Name: nCPAP
  • Device: NIPPV
    Deliver non-invasive respiratory support via ventilator with NIPPV device
    Other Name: NIPPV
  • Active Comparator: A
    Non-invasive respiratory support via nasal intermittent positive pressure ventilation
    Intervention: Device: NIPPV
  • Active Comparator: B
    Non-invasive respiratory support via nasal Continuous Positive Airway Pressure
    Intervention: Device: nCPAP
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1011
December 2011
August 2011   (final data collection date for primary outcome measure)

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
Both
up to 28 Days
No
Contact information is only displayed when the study is recruiting subjects
United States,   Austria,   Belgium,   Canada,   Ireland,   Netherlands,   Qatar,   Singapore,   Sweden,   United Kingdom
 
NCT00433212
NTG-2007-NIPPV, CIHR MCT-80246, ISRCTN15233270
Yes
McMaster University
McMaster University
Canadian Institutes of Health Research (CIHR)
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
McMaster University
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP