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

• Register: ISRCTN
• Last refreshed on: 17 October 2016
• Main ID: ISRCTN11928413
• Date of registration: 13/02/2015
• Prospective Registration: No
• Primary sponsor: Section of Neonatology of the Portuguese Society of Paediatrics
• Public title: Comparison of two modes of non-invasive ventilation in preterm babies
• Scientific title: 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
• Date of first enrolment: 15/05/2011
• Target sample size: 200
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN11928413
• Study type: Interventional
• Study design: The study is an interventional randomised controlled multicentre trial enrolling preterm infants born 27 to 32 weeks and 6 days of gestation. (Treatment)

Countries of recruitment

Portugal

Contacts

• Name: Teresa Aguiar

Key inclusion & exclusion 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: 1. Need of endotraqueal intubation in the delivery room
2. Major congenital malformations
3. Neuromuscular diseases
4. Perinatal asphyxia ( Apgar < 4 at 5 minutes and base excess of > -12 in the first hour)
5. Early onset sepsis

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Respiratory distress syndrome at birth
Respiratory

Intervention(s)

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 was made. Babies who showed an effective respiratory drive in the delivery room were immediately connected to an Infant Flow device for non-invasive ventilation (nCPAP -PEEP of 6 cm H2O) and transferred to the NICU. To those who hadn´t well succeeded breathing movements, positive pressure ventilation with silicone mask was applied. If an effective breath was achieved in 30 seconds, the previous procedure was followed.
At NICU admission, enrolled infants were randomly assigned to nCPAP or BiPAP using sequentially numbered sealed opaque envelopes. Randomization by variable 2-4 blocks was stratified in two GA categories: 27 weeks to 29 weeks + 6 days of GA and 30 weeks to 32 weeks + 6 days. In this study Infant Flow® devices were used- Infant Flow® Nasal CPAP System (IF; 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 envelope. If they belong to Bilevel CPAP group a positive end expiratory pressure (PEEP) 1of 6 cm H2O; 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 sampling for hemogram, CPR (C protein reactive), culture, blood group and blood gas analysis were taken. Thoracic-abdominal X ray was done. All infants received caffeine citrate ( loading dose 20 mg/Kg and maintenance dose 8 mg/Kg/day). At 30-45 minutes of life, a clinical reevaluation was made. If the infant was stable, the same parameters would be kept. If there was a sign of respiratory distress, parameters would be changed (In the CPAP group, PEEP was raised to 7-8 cm H2O; in the BiPAP group, if there was apnoea

Primary Outcome(s)

The primary outcome of our study was the need of invasive ventilation within the first 120 hours of life. Intubation criteria were: pH <7.25, pCO2> 65 mmHg, SatO2 <88% with FiO2 = 40%, one episode of apnoea requiring bag -and-mask ventilation, frequent episodes of bradycardia/apnoea (>2-3 per hour).

Secondary Outcome(s)

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.

Secondary ID(s)

N/A

Source(s) of Monetary Support

Section of Neonatology of the Portuguese Society of Paediatrics (Portugal)