Comparison of two modes of non-invasive ventilation in preterm babies

Randomized controlled trial comparing nasal bilevel and continuous positive airway pressure in preterm infants born 27 to 32 weeks and 6 days of gestation regarding the need of intubation within the first 120 hours

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN11928413

Enrollment

200

Registered

2015-02-13

Start date

2011-05-15

Completion date

Unknown

Last updated

2016-10-17

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

Conditions

Respiratory distress syndrome at birth Respiratory

Interventions

The study included the inborn infants with gestational age (GA) between 27 weeks and 32 weeks + 6 days, whose parents had signed an informed consent before delivery. At birth, delayed cord clamping wa

Care Fusion) and Infant Flow® SiPAP System (Vyasis , Care Fusion) and the nasal interfaces were short binasal prongs. Infants were placed in bilevel CPAP or nasal CPAP according to the randomised enve

PEEP2 of 8 cm H2O, inspiratory time (Ti) of 2 sec and a rate of 10 were applied. If they belong to CPAP group , a PEEP of 6 cm H2O was applied. Insertion of umbilical lines were performed. Blood sa

in the BiPAP group, if there was apnoea

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Infants with gestational age (GA) between 27 weeks and 32 weeks + 6 days 2. Either gender 3. Parents had signed an informed consent before delivery 4. Don't need endotraqueal intubation at birth

Exclusion criteria

Exclusion criteria: 1. Need of endotraqueal intubation in the delivery room 2. Major congenital malformations 3. Neuromuscular diseases 4. Perinatal asphyxia ( Apgar -12 in the first hour) 5. Early onset sepsis

Design outcomes

Primary

Measure	Time frame
The primary outcome of our study was the need of invasive ventilation within the first 120 hours of life. Intubation criteria were: pH 65 mmHg, SatO2 2-3 per hour).	—

Secondary

Measure	Time frame
1. Duration of mechanical ventilation 2. Use of surfactant 3. Incidence of pneumothorax 4. Bronchopulmonary dysplasia (BPD- defined as need of oxygen supplementation at 36 weeks of gestation) 5. Peri and intraventricular haemorrhage (Volpe grades III/IV) 6. Necrotizing enterocolitis ( Bell´s stage >2) 7. Severe retinopathy of prematurity (grade >2) 8. Patent ductus arteriosus (PDA) 9. Sepsis (defined as positive hemoculture 10. Clinical signs and intention to treat) 11. Length of stay and mortality The outcomes were measured throughout the hospitalisation period.	—

Measure

Time frame

1. Duration of mechanical ventilation 2. Use of surfactant 3. Incidence of pneumothorax 4. Bronchopulmonary dysplasia (BPD- defined as need of oxygen supplementation at 36 weeks of gestation) 5. Peri and intraventricular haemorrhage (Volpe grades III/IV) 6. Necrotizing enterocolitis ( Bell´s stage >2) 7. Severe retinopathy of prematurity (grade >2) 8. Patent ductus arteriosus (PDA) 9. Sepsis (defined as positive hemoculture 10. Clinical signs and intention to treat) 11. Length of stay and mortality The outcomes were measured throughout the hospitalisation period.

—

Countries

Portugal

Outcome results

None listed

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