Comparison of effectiveness two Infant Flow modes (Biphasic tr vs NCPAP) in treatment infants ≤ 1250g

ISRCTN	ISRCTN88744949
DOI	https://doi.org/10.1186/ISRCTN88744949
Protocol serial number	N N407 454237
Sponsor	Polish Ministry of Science and Higher Education (Poland)
Funders	Polish Ministry of Science and Higher Education (Poland), The Great Orchestra of Christmas Charity (Poland)

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

Broniewskiego St. 1a/20
Katowice
40-125
Poland

Phone	+48 (0)662 061 530
Email	bober_k@interia.pl

Study information

Primary study design	Interventional
Study design	Multicentre randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	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)
Key secondary outcome measure(s)	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
Completion date	31/12/2012

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	All
Target sample size at registration	552
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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes