Plain English Summary

Not provided at time of registration

Trial website

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

http://www.mcmaster.ca/

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

  1. 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.

Editorial Notes