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11 February 2012
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| [ Print-friendly version ] |
| Comparing non-invasive respiratory support methods following surgery in neonates with risk of extubation failure |
| ISRCTN | ISRCTN94827278 |
| ClinicalTrials.gov identifier | |
| Public title | Comparing non-invasive respiratory support methods following surgery in neonates with risk of extubation failure |
| 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 |
| Acronym | NRSPRCT2 |
| Serial number at source | N/A |
| Study hypothesis | 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. |
| Lay summary | |
| Ethics approval | Bioethical Committee of the Children's Memorial Health Institute, Warsaw, Poland, approved on the 30th October 2009 (ref: 41/KBE/2009) |
| Study design | Multicentre randomised unblinded controlled clinical trial |
| Countries of recruitment | Poland |
| Disease/condition/study domain | Extubation failure in neonates |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 28/06/2010 |
| Anticipated end date | 30/12/2012 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 150 babies in each arm of the study (in total 300 babies) |
| Interventions |
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. |
| Primary outcome measure(s) |
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 measure(s) |
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 |
| Sources of funding | The Great Orchestra of Christmas Charity (Poland) |
| Trial website | |
| Publications | |
| Contact name | Dr Janusz Swietlinski |
| Address | Damrota 106 |
| City/town | Tychy |
| Zip/Postcode | 43-100 |
| Country | Poland |
| Tel | +48 (0)608 346 432 |
| j.swietlinski@czd.pl | |
| Sponsor | The Great Orchestra of Christmas Charity (Poland) |
| Address | ul. Niedzwiedzia 2A |
| City/town | Warszawa |
| Zip/Postcode | 02-737 |
| Country | Poland |
| Sponsor website: | http://www.wosp.org.pl |
| Date applied | 23/06/2010 |
| Last edited | 12/07/2010 |
| Date ISRCTN assigned | 12/07/2010 |
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