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

Completed

• Conditions: eonatal Diseases: Respiratory; Neonatal Diseases

• Registration Number: ISRCTN88744949
• Lead Sponsor: Polish Ministry of Science and Higher Education (Poland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08-26
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 552

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified