Contact information
Type
Scientific
Primary contact
Dr Haresh Murli Kirpalani
ORCID ID
Contact details
Room 3N11F
McMaster University Medical Center
1200 Main Street West
Hamilton
Ontario
L8N 3Z5
Canada
+1 905 521 2100 ext. 73024
kirpalan@mcmaster.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00433212
Protocol/serial number
MCT-80246
Study information
Scientific title
Nasal ventilation in preterms (NIP) trial
Acronym
NIPPV
Study hypothesis
The use of nasal intermittent positive pressure ventilation (NIPPV) leads to a higher rate of survival without brochopulmonary dysplasia than standard therapy with nasal continuous positive airways pressure (nCPAP).
As of 19/08/2009 this record has been updated to include an extended anticipated end date; the initial anticipated end date of your trial was 30th April 2009.
Ethics approval
Ethics approval was gained from Research Ethics Boards of:
1. Hamilton Health Sciences, Hamilton, Ontario, Canada on the 19th September 2006 (ref: #06-365)
2. Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada on the 11th January 2007 (ref: 06/30E)
3. Intermountain Healthcare (Institutional Review Board), Salt Lake City, Utah, USA on the 12th April 2007 (ref: # 06.2102)
Ethics approvals from other countries are pending.
Study design
Multicentre, international, randomised parallel, two arm placebo trial, with outcome assessor and data analyst blinded.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Bronchopulmonary dysplasia
Intervention
Experimental group: NIPPV as the sole non-ventilation respiratory support, until final weaning from all forms of respiratory support
Control group: nCPAP - nasal CPAP as the sole non-ventilation respiratory support, until final weaning from all forms of respiratory support.
Contact for public queries:
Dr. Brigitte Lemyre
Children's Hospital of Eastern Ontario (CHEO) (Canada)
401 Smyth Road
Ottawa, ON
Canada K1H 8L1
Phone: +1 613 737 8561
Fax: +1 613 737 8889
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
A composite primary outcome of survival to 36 weeks gestational age, free of moderate-severe bronchopulmonary dysplasia (BPD) (i.e. major event-free survival at 36 weeks gestational age). Following the US National Institutes for Child Health and Development (NIHCHD) Consensus Statement moderate-severe BPD is defined as requiring oxygen or any respiratory support at 36 weeks age. Formal assessment for the requirement of oxygen will be conducted using the oxygen reduction test developed by Walsh.
Secondary outcome measures
1. All cause mortality at 36 weeks gestational age
2. All cause mortality before first discharge home
3. Bronchopulmonary dysplasia assessed at 36 weeks gestational age
4. Need for re-intubation by birth weight strata (less than 750 g; 750 g - 999 g)
5. Primary outcome per type and time of respiratory support at randomisation
6. Comparison of synchronised and non-synchronised NIPPV as a function of their effect on the primary outcome (survival at 36 weeks gestational age free of BPD)
7. Total duration of positive pressure respiratory support, i.e. mechanical ventilation plus either NIPPV or nCPAP, up to the time of discharge from the Neonatal Intensive Care Unit (NICU)
8. Total time on supplemental oxygen until discharge from NICU
9. Pulmonary air leaks identified radiologically by a masked paediatric radiologist - up to weaning off respiratory support
10. Nasal deformities: columella nasi necrosis or epistaxis
11. Intestinal perforation diagnosed by free gas in the peritoneal cavity on abdominal radiograph or at laparotomy
12. Necrotising enterocolitis, diagnosed at surgery, autopsy or by the radiographic findings of pneumatosis intestinalis or hepatobiliary gas (Bell stage II)
13. Time to establish full feeds (no longer requiring parenteral nutrition)
14. Weight gain - comparison at 36 weeks gestational age
15. Nosocomial infections, defined as positive blood culture, positive cerebrospinal fluid (CSF) culture and/or diagnosis of pneumonia
Overall trial start date
01/09/2006
Overall trial end date
31/12/2010
Reason abandoned
Eligibility
Participant inclusion criteria
Group A: complete obstetric and neonatal history and a clinical examination are required to confirm eligibility, however, results of study-specific laboratory or radiological investigations are not required to judge patient eligibility.
1. Gestational age at birth less than 30 weeks, either sex
2. Birthweight 999 grams or less
3. Intention to manage the infant with non-invasive respiratory support (i.e. no endotracheal tube), where either:
Group B: 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;
OR
Group B: 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.
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
1000
Participant exclusion criteria
1. Life-threatening congenital abnormalities including congenital heart disease (excluding patent ductus arteriosus)
2. Infants known to require surgical treatment, e.g. congenital diaphragmatic hernia, trache-oesophageal fistula, omphalocele, gastroschisis
3. Abnormalities of the upper and lower airways such as Pierre-Robin sequence, Treacher-Collins syndrome, Goldenhar syndrome, cleft lips and palate
4. Neuromuscular disorders
Recruitment start date
01/09/2006
Recruitment end date
31/12/2010
Locations
Countries of recruitment
Australia, Canada, Germany, Singapore, Sweden, United Kingdom, United States of America
Trial participating centre
Room 3N11F, McMaster University Medical Center
Hamilton, Ontario
L8N 3Z5
Canada
Sponsor information
Organisation
McMaster University (Canada)
Sponsor details
Department Clinical Epidemiology
c/o Ms Deborah Billings
Room HSC-2C4
1200 Main Street West
Hamilton
Ontario
L8N 3Z5
Canada
+1 905 525 9140 ext. 22665
billings@mcmaster.ca
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr.irsc.gc.ca (ref: MCT-80246)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23944299
Publication citations
-
Results
Kirpalani H, Millar D, Lemyre B, Yoder BA, Chiu A, Roberts RS, , A trial comparing noninvasive ventilation strategies in preterm infants., N. Engl. J. Med., 2013, 369, 7, 611-620, doi: 10.1056/NEJMoa1214533.