Humidified High Flow Nasal Cannula Versus Nasal Intermittent Positive Ventilation in Neonates as Primary Respiratory Support:a Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Enrollment
- 200
- Primary Endpoint
- endotracheal intubation rate
Study Overview
Brief Summary
The investigators hypothesize that the Humidified High Flow Nasal Cannula(HHFNC) is effective and safe as primary respiratory support in neonate with respiratory distress syndrome(RDS). It is more convenient in HHFNC combined with kangaroo care.
Detailed Description
Today a new nursing principle proposed that is kangaroo care in neonate.Many study showed kangaroo care may reduce pain、decrease the respiratory and heart rate among preterm infant.The recently study show it benefit to Physical Growth and Neurodevelopment.
Respiratory failure remains a common problem in the neonatal intensive unit. As reported that early non-invasive ventilation is accompanied by significant improvement in subsequent lung development and alveolation.Nasal continuous positive airway pressure (NCPAP)、nasal intermittent positive pressure ventilation(NIPPV) and humidified high flow via nasal cannulas(HHFNC) are non-invasive ventilation models.But Unfortunately, NIPPV and NCPAP systems are not always easily applied or tolerated in the preterm infants.So it is not convenient in kangaroo care.Recently A meta analysis concluded that NIPPV is more effective than NCPAP in preterms respiratory diseases.Maybe the investigators can reason that NIPPV is effective than HHFNC,but there is limited data about the comparison of NIPPV and HHFNC as primary respiratory support in neonate.
The NIPPV group fail definition：1、FiO2>40%、MAP>10 centimeter water column (cm H2O),but SaO2<90%.2、significant abdominal distension.3、PaCO2>60 millimeter of mercury (mmHg)or partial pressure of arterial oxygen (PaO2)<45mmHg.4、severe apnea( definition:>6 episodes requiring stimulation in 6 hours or requiring >1 episodes of positive-pressure ventilation) 5.potential of hydrogen (PH)<7.2 The HHFNC group fail definition：1、FiO2>40%、flow>8 (litre,L)/min,but SaO2<90%.2、significant abdominal distension.3、PaCO2>60mmHg or PaO2<45mmHg.4、severe apnea 5.PH<7.2
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- — to 28 Days (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Birth weight > 1000 grams and > 28 weeks gestation
- •have respiratory distress syndrome and need assistant ventilation
Exclusion Criteria
- •Birth weight < 1000 grams
- •Estimated gestation < 28 weeks
- •infants have contraindications for use of non-invasive ventilation
- •Active air leak syndrome
- •Infants with abnormalities of the upper and lower airways; such as Pierre- Robin, Treacher-Collins, Goldenhar, choanal atresia or stenosis, cleft lip and/or palate, or
- •Infants with significant abdominal or respiratory malformations including trachea-esophageal fistula, intestinal atresia, omphalocele, gastroschisis, and congenital diaphragmatic hernia.
Outcomes
Primary Outcomes
endotracheal intubation rate
Time Frame: 3 days
endotracheal intubation rate assessed within 72 hours after extubation
Secondary Outcomes
- full enteral feeding(3 months)
- significant apnea(7 days)
- duration of non-invasive ventilation(3 months)
- nasal trauma(3 months)
- air leaks(3 months)
- Bronchopulmonary dysplasia(3 months)
- necrotizing enterocolitis(3 months)
Investigators
Gao WeiWei
professor
Guangdong Women and Children Hospital