Contact information
Type
Scientific
Primary contact
Dr Klaudiusz Bober
ORCID ID
Contact details
Broniewskiego St. 1a/20
Katowice
40-125
Poland
+48 (0)662 061 530
bober_k@interia.pl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N N407 454237
Study information
Scientific title
Comparison of effectiveness two Infant Flow modes (Biphasic tr vs NCPAP) in treatment infants ≤ 1250g. A multicentre, randomised controlled trial
Acronym
NRSPRCT3
Study hypothesis
To compare the efficacy and safety of treatment using two Infant Flow modes (Biphasic tr and NCPAP) in two different study groups of very low birth weight (VLBW) infants (elective to avoid intubation and weaning from mechanical ventilation after surfactant).
Ethics approval
Bioethical Committee of the Medical University of Silesia, Katowice, Poland, approved on the 10th July 2008 (ref: KNW/6501-114/08)
Study design
Multicentre randomised controlled 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
Neonatal Diseases: Respiratory
Intervention
Newborns weighing between 500-1250g with a gestational age 32 weeks or less, will be categorised into elective or weaning study group and randomly assigned to one of the Infant Flow mode (Biphasic tr or NCPAP ) in first six hours of life. Infants that meet criteria for intubation and surfactant will be assigned to the weaning arm of the study. Infants that not meet intubation criteria but required respiratory support within six hours of delivery will be enrolled in the elective arm of the study. Extubation failure in the weaning group is defined as the need for reintubation and mechanical ventilation for any reason within 72 hours of initial extubation.
Treatment failure in the elective group is defined as need for intubation in the first 3 days after first weaning from nCPAP.
Secondary endpoints include: mortality, survival without broncho-pulmonary dysplasia (BPD) or chronic lung disease (CLD), number of days on CPAP, number of days on mechanical ventilation, days on supplemental oxygen, pneumothorax, nasal complications, severe intraventricular hemorrhage, periventricular leukomalacia, retinopathy of prematurity, necrotizing enterocolitis, patient ductus arteriosus and the length of hospital stay.
The sites will be visited regularly by Study Monitors. A database of the results will be maintained by an independent data centre. The results of the study will be blinded to the Investigators, but review every 6 months by an independent Data Safety Monitoring Board according to specific criteria. Prospective power calculations indicated the need for 552 infants to be enrolled. Infants will be followed up until hospital discharge or death.
Secondary Sponsor:
The Great Orchestra of Christmas Charity (Poland)
Niedzwiedzia St. 2A
Warsaw
02-737
Poland
http://www.wosp.org.pl
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. Study group A (elective):
1.1. Need for intubation within 72 hours after first weaning from nCPAP, indicated by:
1.1.1. Laboratory:
1.1.1.1. pH<7.2 AND pCO2>8,65kPa (65mmHg)
1.1.1.2. SpO2 less than 88% on FiO2 greater than 0.6
1.1.2. Clinical:
1.1.2.1. Marked increase in respiratory effort
1.1.2.2. Persistent apnea
1.1.2.3. Need for bag ventilation
1.1.2.4. 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. Study group B (weaning):
2.1. Need for intubation within 72 hours after first weaning from mechanical ventilation, indicated by:
2.1.1. Laboratory:
2.1.1.1. pH<7.2 AND pCO2>8,65kPa (65mmHg)
2.1.1.2. SpO2 less than 88% on FiO2 greater than 0.6
2.1.2. Clinical:
2.1.2.1. Marked increase in respiratory effort
2.1.2.2. Persistent apnOea
2.1.2.3. Need for bag ventilation
2.1.2.4. Frequent apnoeas with bradycardia less than 100/min (lack of respiratory efforts for more than 20 seconds, need for stimulation greater than 3/h)
Secondary outcome measures
1. Study group A (elective):
1.1. Total respiratory support
1.2. Duration of CPAP days
1.3. Days oxygen therapy
1.4. Length of hospital stay
1.5. Pulmonary complications (pneumothorax, interstitial emphysema, broncho-pulmonary dysplasia, chronic lung disease)
1.6. Extrapulmonary complications (intraventricular haemorrhage, periventricular leukomalacia, persistent ductus arteriosus, necrotizing enterocolitis, retinopathy of prematurity)
1.7. Local (nasal) complications
2. Study group B (weaning):
2.1. Total respiratory support
2.2. Duration of mechanical ventilation days
2.3. Duration of CPAP days
2.4. Days oxygen therapy
2.5. Length of hospital stay
2.6. Pulmonary complications (pneumothorax, interstitial emphysema, broncho-pulmonary dysplasia, chronic lung disease)
2.7. Extrapulmonary complications (intraventricular haemorrhage, periventricular leukomalacia, persistent ductus arteriosus, necrotizing enterocolitis, retinopathy of prematurity)
2.8. Local (nasal) complications
Overall trial start date
15/08/2010
Overall trial end date
31/12/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Study group A (elective):
1.1. Preterm newborns (≤32 gestational weeks)
1.2. Birth weight 500-1250g
1.3. Any indications to intubation after birth
1.4. Signed informed consent by a parent or legal guardian
2. Study group B (weaning):
2.1. Preterm newborns (≤ 32 gestational weeks)
2.2. Birth weight 500-1250g
2.3. Clinical signs and symptoms of severe RDS
2.4. Indications into surfactant administration after delivery
2.5. Signed informed consent by a parent or legal guardian
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
Total number of babies required will be 552 (276 each group)
Participant exclusion criteria
1. Study group A (elective):
1.1. Preterm newborns (>32 gestational weeks)
1.2. Birth weight <500 and >1250g
1.3. Presence of congenital malformations
1.4. APGAR score < 4 (at 5min)
1.5. Incidence of air leaks
1.6. The lack of written parental consent
2. Study group B (weaning):
2.1. Preterm newborns (>32 gestational weeks)
2.2. Birth weight <500 and >1250g
2.3. Presence of congenital malformations
2.4. APGAR score < 4 (at 5min)
2.5. Incidence of air leaks
2.6. The lack of written parental consent
Recruitment start date
15/08/2010
Recruitment end date
31/12/2012
Locations
Countries of recruitment
Poland
Trial participating centre
Broniewskiego St. 1a/20
Katowice
40-125
Poland
Sponsor information
Organisation
Polish Ministry of Science and Higher Education (Poland)
Sponsor details
Wspólna St. 1/3
Warsaw
00-529
Poland
+48 (0)22 5292718
katarzyna.stefanska@nauka.gov.pl
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Polish Ministry of Science and Higher Education (Poland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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