Overview

This trial is active, not recruiting.

Condition respiratory insufficiency
Treatments nippv, hhfnc
Phase phase 1
Sponsor Gao WeiWei
Start date February 2016
End date May 2017
Trial size 200 participants
Trial identifier NCT02499744, GuangdongWCHHI

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
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.
hhfnc Humidified High Flow Nasal Cannula
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.
(Active Comparator)
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 .
nippv nasal intermittent postive pressure ventilaiton
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.

Primary Outcomes

Measure
endotracheal intubation rate
time frame: 3 days

Secondary Outcomes

Measure
significant apnea
time frame: 7 days
duration of non-invasive ventilation
time frame: 3 months
air leaks
time frame: 3 months
full enteral feeding
time frame: 3 months
Bronchopulmonary dysplasia
time frame: 3 months
necrotizing enterocolitis
time frame: 3 months
nasal trauma
time frame: 3 months

Eligibility Criteria

Male or female participants up to 28 days old.

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.

Additional Information

Official title Humidified High Flow Nasal Cannula Versus Nasal Intermittent Positive Ventilation in Neonates as Primary Respiratory Support:a Randomized Controlled Trial
Principal investigator yang jie, doctor
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
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Guangdong Women and Children's Hospital and Health Institute.