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

Phase 1

• Conditions: Respiratory Insufficiency
• Interventions: Device: HHFNC; Device: NIPPV

• Registration Number: NCT02499744
• Lead Sponsor: Gao WeiWei

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 Timeline

• Study First Submitted: 2015-05-24
• Study First Submitted QC: 2015-07-14
• Study First Posted: 2015-07-16
• Status Verified: 2016-02
• Study Start: 2016-02
• Last Update Submitted: 2016-02-22
• Last Update Posted: 2016-02-24
• Primary Completion: 2017-05
• Study Completion: 2017-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Birth weight > 1000 grams and > 28 weeks gestation
2. have respiratory distress syndrome and need assistant ventilation

Exclusion Criteria

1. Birth weight < 1000 grams
2. Estimated gestation < 28 weeks
3. infants have contraindications for use of non-invasive ventilation
4. Active air leak syndrome
5. 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
6. Infants with significant abdominal or respiratory malformations including trachea-esophageal fistula, intestinal atresia, omphalocele, gastroschisis, and congenital diaphragmatic hernia.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HHFNC	HHFNC	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.
NIPPV	NIPPV	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 .

Primary Outcome Measures

Name	Time	Method
endotracheal intubation rate	3 days	endotracheal intubation rate assessed within 72 hours after extubation

Secondary Outcome Measures

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