Nasal Intermittent Positive Pressure Ventilation
| ISRCTN | ISRCTN15233270 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15233270 |
| ClinicalTrials.gov number | NCT00433212 |
| Secondary identifying numbers | 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
Scientific
Room 3N11F, McMaster University Medical Center
1200 Main Street West
Hamilton, Ontario
L8N 3Z5
Canada
| Phone | +1 905 521 2100 ext. 73024 |
|---|---|
| kirpalan@mcmaster.ca |
Study information
| 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 |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/09/2006 |
| Completion date | 31/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 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
- Australia
- Canada
- Germany
- Singapore
- Sweden
- United Kingdom
- United States of America
Study participating centre
Room 3N11F, McMaster University Medical Center
Hamilton, Ontario
L8N 3Z5
Canada
L8N 3Z5
Canada
Sponsor information
McMaster University (Canada)
University/education
University/education
Department Clinical Epidemiology
c/o Ms Deborah Billings, Room HSC-2C4
1200 Main Street West
Hamilton, Ontario
L8N 3Z5
Canada
| Phone | +1 905 525 9140 ext. 22665 |
|---|---|
| billings@mcmaster.ca | |
| Website | http://www.mcmaster.ca/ |
"ROR" |
https://ror.org/02fa3aq29 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr.irsc.gc.ca (ref: MCT-80246)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
