Comparison of effectiveness two Infant Flow modes (Biphasic tr vs NCPAP) in treatment infants ≤ 1250g
| ISRCTN | ISRCTN88744949 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88744949 |
| Secondary identifying numbers | N N407 454237 |
- Submission date
- 06/08/2010
- Registration date
- 26/08/2010
- Last edited
- 26/08/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Neonatal Diseases
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 Klaudiusz Bober
Scientific
Scientific
Broniewskiego St. 1a/20
Katowice
40-125
Poland
| Phone | +48 (0)662 061 530 |
|---|---|
| bober_k@interia.pl |
Study information
| Study design | Multicentre randomised controlled trial |
|---|---|
| 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 | Comparison of effectiveness two Infant Flow modes (Biphasic tr vs NCPAP) in treatment infants ≤ 1250g. A multicentre, randomised controlled trial |
| Study acronym | NRSPRCT3 |
| Study objectives | 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(s) | Bioethical Committee of the Medical University of Silesia, Katowice, Poland, approved on the 10th July 2008 (ref: KNW/6501-114/08) |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 15/08/2010 |
| Completion date | 31/12/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | Total number of babies required will be 552 (276 each group) |
| Key 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 |
| Key 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 |
| Date of first enrolment | 15/08/2010 |
| Date of final enrolment | 31/12/2012 |
Locations
Countries of recruitment
- Poland
Study participating centre
Broniewskiego St. 1a/20
Katowice
40-125
Poland
40-125
Poland
Sponsor information
Polish Ministry of Science and Higher Education (Poland)
Government
Government
Wspólna St. 1/3
Warsaw
00-529
Poland
| Phone | +48 (0)22 5292718 |
|---|---|
| katarzyna.stefanska@nauka.gov.pl | |
| Website | http://www.nauka.gov.pl |
"ROR" |
https://ror.org/05dwvd537 |
Funders
Funder type
Government
Polish Ministry of Science and Higher Education (Poland)
No information available
The Great Orchestra of Christmas Charity (Poland)
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 |
