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

Gao WeiWei200 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Respiratory Insufficiency

Interventions

NIPPVDEVICE

For infants in the NIPPV-group who "fail"NIPPV (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.

HHFNCDEVICE

For infants in the HHFNC-group who "fail"HHFNC (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.

Eligibility

Sex: ALLMax age: 28 Days

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

endotracheal intubation rate

endotracheal intubation rate assessed within 72 hours after extubation

Time frame: 3 days

Secondary Outcomes

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

Time frame: 7 days

duration of non-invasive ventilation

the duration of ventilation measured by total non-invasive ventilation time in HHFNC and NIPPV groups

Time frame: 3 months

air leaks

air leak assessed by chest X-ray

Time frame: 3 months

full enteral feeding

full enteral feeding measured by total feeding dose above 120 ml per kilogram one day

Time frame: 3 months

Bronchopulmonary dysplasia

Bronchopulmonary dysplasia assessed by national institute of child health and human development(NICHD) definition

Time frame: 3 months

necrotizing enterocolitis

necrotizing enterocolitis assessed by abdominal X-ray and Bell classification

Time frame: 3 months

nasal trauma

nasal trauma measured by US national pressure Ulcer Advisory Panel(NPUAP)

Time frame: 3 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.