Condition category
Neonatal Diseases
Date applied
06/08/2010
Date assigned
26/08/2010
Last edited
26/08/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.nauka.gov.pl

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes