Humidified High Flow Nasal Cannula Versus Nasal Intermittent Positive Ventilation in Neonates

Study Overview
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Brief Summary
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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
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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

Official Title
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Humidified High Flow Nasal Cannula Versus Nasal Intermittent Positive Ventilation in Neonates as Primary Respiratory Support:a Randomized Controlled Trial

Conditions
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Respiratory Insufficiency

Intervention / Treatment
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* Device: NIPPV
* Device: HHFNC


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 28 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HHFNC<br>HHFNC is provided nasal cannula. Ventilator settings:fraction of inspired oxygen (FiO2):21-40%,flow:2-8(litre,L)/min,to maintain arterial blood hemoglobin oxygen saturation ( SaO2) at 90-95% The weaning process is left to the discretion of the attending physician.,when FiO2: 25%,flow:2(litre,L)/min. | Device: HHFNC<br>* For infants in the HHFNC-group who failHHFNC (see definition below), need immediate intubation, a invasive Rescue-Treatment may be provided. The decision to attempt Rescue-Treatment, the mode of respiratory support and the ventilator settings used are at the discretion of the attending clinician.<br>* Other names: Humidified High Flow Nasal Cannula;|
| Active Comparator: NIPPV<br>NIPPV is provided via binasal prongs. Ventilator settings:FiO2:21-40%,peak inspiratory pressure( PIP)：12-22cm H2O,positive and expiratory pressure(PEEP):5-7cm H2O,Rate:30-60 per minute to maintain SaO2 at 90-95%,The weaning process is left to the discretion of the attending physician,when FiO2: 25%,mean airway pressure (MAP):6cm H2O,R:30 per minute . | Device: NIPPV<br>* For infants in the NIPPV-group who failNIPPV (see definition below), need immediate intubation, a invasive Rescue-Treatment may be provided. The decision to attempt Rescue-Treatment, the mode of respiratory support and the ventilator settings used are at the discretion of the attending clinician.<br>* Other names: nasal intermittent postive pressure ventilaiton;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| endotracheal intubation rate | endotracheal intubation rate assessed within 72 hours after extubation | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| significant apnea | significant apnea measured by the Colin J definition:6 episodes requiring stimulation in 6 hours or requiring>1 episodes of positive -pressure ventilation | 7 days | 
| duration of non-invasive ventilation | the duration of ventilation measured by total non-invasive ventilation time in HHFNC and NIPPV groups | 3 months | 
| air leaks | air leak assessed by chest X-ray | 3 months | 
| full enteral feeding | full enteral feeding measured by total feeding dose above 120 ml per kilogram one day | 3 months | 
| Bronchopulmonary dysplasia | Bronchopulmonary dysplasia assessed by national institute of child health and human development(NICHD) definition | 3 months | 
| necrotizing enterocolitis | necrotizing enterocolitis assessed by abdominal X-ray and Bell classification | 3 months | 
| nasal trauma | nasal trauma measured by US national pressure Ulcer Advisory Panel(NPUAP) | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RDS, neonate, NIPPV, HHFNC