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

Comparison of effectiveness two Infant Flow modes (Biphasic tr vs NCPAP) in treatment infants = 1250g. A multicentre, randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN88744949

Enrollment

552

Registered

2010-08-26

Start date

2010-08-15

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Diseases: Respiratory Neonatal Diseases

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: 1. Study group A (elective): 1.1. Preterm newborns (>32 gestational weeks) 1.2. Birth weight 1250g 1.3. Presence of congenital malformations 1.4. APGAR score 32 gestational weeks) 2.2. Birth weight 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

Design outcomes

Primary

Measure	Time frame
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. pH8,65kPa (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. pH8,65kPa (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)	—

Measure

Time frame

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. pH8,65kPa (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. pH8,65kPa (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)

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Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Poland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026