Comparing non-invasive respiratory support methods following surgery in neonates with risk of extubation failure
ISRCTN | ISRCTN94827278 |
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DOI | https://doi.org/10.1186/ISRCTN94827278 |
Secondary identifying numbers | N/A |
- Submission date
- 23/06/2010
- Registration date
- 12/07/2010
- Last edited
- 12/07/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Janusz Swietlinski
Scientific
Scientific
Damrota 106
Tychy
43-100
Poland
Phone | +48 (0)608 346 432 |
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j.swietlinski@czd.pl |
Study information
Study design | Multicentre randomised unblinded controlled clinical trial |
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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 | Does non-invasive positive pressure ventilation (NIPPV) support following surgery in neonates gives an advantage over standard oxygen/nasal continuous positive airways pressure (NCPAP) treatment in prevention of extubation failure: a multicentre randomised controlled trial |
Study acronym | NRSPRCT2 |
Study objectives | We will perform a prospective, randomised clinical trial to test the hypothesis that prophylactic application of non-invasive positive pressure ventilation (NIPPV) infants following surgery who are at high risk of reintubation will reduce extubation failure rate as compared to standard care. Standard care is defined as nasal continuous positive airways pressure (NCPAP) for infants weighing less than 2000 g and oxygen for those larger. |
Ethics approval(s) | Bioethical Committee of the Children's Memorial Health Institute, Warsaw, Poland, approved on the 30th October 2009 (ref: 41/KBE/2009) |
Health condition(s) or problem(s) studied | Extubation failure in neonates |
Intervention | Extubation following surgery is done according to defined criteria. Newborns above 2000 g are weaned on oxygen with fraction of inspired oxygen (FiO2) to achieve adequate peripheral oxygen saturation (SpO2), and newborns below 2000 g are weaned on NCPAP, 4 cm H2O with FiO2 to achieve adequate SpO2. During the next 360 minutes babies are closely observed for defined risk of weaning failure. Infants with such a risk are randomised to: 1. Control arm: standard therapy - nothing is changed, or 2. Treatment arm: infant flow - NIPPV support Treatment in both arms are continued until failure - intubation, or to time depended on individual clinical condition of the baby. The primary end point is intubation at 48 hours after extubation, the other end points are measured at 72 hours and 7 days after extubation. The observation is closed after 7 days. |
Intervention type | Procedure/Surgery |
Primary outcome measure | 1. Intubation at 48 hours after extubation. Weaning failure criteria as follows: 1.1. SpO2 less than 90% on FiO2 greater than 0.4, or 1.2. pH less than 7.20, or 1.3. PaCO2 greater than 65 mmHg 2. Clinical findings: 2.1. Marked increase in respiratory effort 2.2. Persistent apnea 2.3. Need for bag ventilation 2.4. Frequent apnoeas with bradycardia less than 100/min (lack of respiratory efforts for more than 20 seconds, need for stimulation greater than 3/h) 2.5. Symptoms of multiple organ failure (MOF) 2.6. Attending physician decision |
Secondary outcome measures | 1. Weaning failure at 72 hours after extubation 2. Time of oxygen and respiratory support in weaning phase 3. Complications: pulmonary (PT, PIE, atelectasis), local (skin lesions connected with prongs or tracheal tubes and apneas 4. Length of stay in the ICU and in the hospital |
Overall study start date | 28/06/2010 |
Completion date | 30/12/2012 |
Eligibility
Participant type(s) | Patient |
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Age group | Child |
Sex | Both |
Target number of participants | 150 babies in each arm of the study (in total 300 babies) |
Key inclusion criteria | 1. Age below 28 days or 44 weeks of corrected age 2. Birth weight greater than or equal to 1500 g 3. Surgery with general anesthesia 4. Baby is unable to wean from respiratory support in the first 6 hours after surgery 5. Parental written consent |
Key exclusion criteria | 1. Birth weight below 1500 g 2. Congenital defects making nasal prongs useless 3. Serious local (skin, nasal) lesions 4. Resuscitation, shock in last 12 hours before surgery 5. Serious central nervous system (CNS) defects or complications 6. Lethal congenital anomalies 7. Transport to other hospital in first 72 hours after surgery |
Date of first enrolment | 28/06/2010 |
Date of final enrolment | 30/12/2012 |
Locations
Countries of recruitment
- Poland
Study participating centre
Damrota 106
Tychy
43-100
Poland
43-100
Poland
Sponsor information
The Great Orchestra of Christmas Charity (Poland)
Charity
Charity
ul. Niedzwiedzia 2A
Warszawa
02-737
Poland
Website | http://www.wosp.org.pl |
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https://ror.org/034dekp80 |
Funders
Funder type
Charity
The Great Orchestra of Christmas Charity (Poland)
No information available
Results and Publications
Intention to publish date | |
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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 |