Nasal Intermittent Positive Pressure Ventilation

ISRCTN	ISRCTN15233270
DOI	https://doi.org/10.1186/ISRCTN15233270
ClinicalTrials.gov (NCT)	NCT00433212
Protocol serial number	MCT-80246
Sponsor	McMaster University (Canada)
Funder	Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr.irsc.gc.ca (ref: MCT-80246)

Submission date: 28/08/2007
Registration date: 28/08/2007
Last edited: 16/08/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Haresh Murli Kirpalani
Scientific

Room 3N11F, McMaster University Medical Center
1200 Main Street West
Hamilton, Ontario
L8N 3Z5
Canada

Phone	+1 905 521 2100 ext. 73024
Email	kirpalan@mcmaster.ca

Study information

Primary study design	Interventional
Study design	Multicentre, international, randomised parallel, two arm placebo trial, with outcome assessor and data analyst blinded.
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Nasal ventilation in preterms (NIP) trial
Study acronym	NIPPV
Study objectives	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(s)	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.
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	31/12/2010

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	All
Target sample size at registration	1000
Key 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.
Key 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
Date of first enrolment	01/09/2006
Date of final enrolment	31/12/2010

Locations

Countries of recruitment

United Kingdom
Australia
Canada
Germany
Singapore
Sweden
United States of America

Study participating centre

Room 3N11F, McMaster University Medical Center

Hamilton, Ontario
L8N 3Z5
Canada

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	15/08/2013		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes