Contact information
Type
Scientific
Primary contact
Dr Janusz Swietlinski
ORCID ID
Contact details
Damrota 106
Tychy
43-100
Poland
+48 (0)608 346 432
j.swietlinski@czd.pl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
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
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.
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
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
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
Phase
Not Applicable
Drug names
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 trial start date
28/06/2010
Overall trial end date
30/12/2012
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
150 babies in each arm of the study (in total 300 babies)
Participant 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
Recruitment start date
28/06/2010
Recruitment end date
30/12/2012
Locations
Countries of recruitment
Poland
Trial participating centre
Damrota 106
Tychy
43-100
Poland
Sponsor information
Organisation
The Great Orchestra of Christmas Charity (Poland)
Sponsor details
ul. Niedzwiedzia 2A
Warszawa
02-737
Poland
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
The Great Orchestra of Christmas Charity (Poland)
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
Basic results (scientific)
Publication list