Nasal High Frequency Oscillatory Versus Nasal Intermittent Positive Pressure Ventilation in Neonate After Extubation

February 22, 2016 updated by: Gao WeiWei
To evaluate the efficacy and safety of nasal high frequency oscillatory ventilation(NHFOV) in preterms with respiratory disease syndrome(RDS) after extubation.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

To very low birth weight infant(VLBW) with respiratory disease syndrome(RDS) who need mechanical ventilation,early extubation may have more benefits.Early extubation may decrease the ventilation-associated pneumonia(VAP),sepsis and decrease the incidence of severity bronchopulmonary dysplasia(BPD).But often fail attempts at extubation because of apnea,atelectasis,hypercapnia,hypoventilation or other illnesses.

High frequency oscillatory ventilation is benefit to lung.Initial ventilation with HFOV in preterm with RDS may reduce the incidence of BPD and improve the neurodevelopment.Compared HFOV with conventional ventilation in preterm infants showed that HFOV had superior lung function when 11 to 14 years age.Whether nasal high frequency oscillatory ventilation(NHFOV) also have those advantages in non-invasive mode? Null D M et al do a experiment on preterm lambs,the result suggest that NHFOV may promotes alveolarization.But there was no clinical trials to prove.

The nasal intermittent positive pressure ventilation (NIPPV) group fail definition：1、 Fraction of inspired oxygen (FiO2)>40%、MAP>12 centimeter water column (cm H2O),but arterial oxygen saturation (SaO2)<90%.2、significant abdominal distension.3、PaCO2>60millimeter of mercury(mmHg)or partial pressure of arterial oxygen (PaO2)<45 millimeter of mercury(mmHg).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

The NHFOV group fail definition：1、FiO2>40%、MAP>14 mbar,but SaO2<90%.2、significant abdominal distension.3、PaCO2>60millimeter of mercury(mmHg) or PaO2<45millimeter of mercury(mmHg).4、severe apnea 5.PH<7.2.

Study Type

Interventional

Enrollment (Anticipated)

75

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. birth weight>1000g
  2. gestational age >28 weeks
  3. have respiratory distress syndrome and need invasive ventilation

Exclusion Criteria:

  1. birth wight<1000g
  2. gestational age <28 weeks
  3. infants wiht abnormalities of upper and lower airways
  4. infants have contraindications of non-invasive ventilation -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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 .
Device: NIPPV
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.
Other Names:
  • SLE 5000
Active Comparator: NHFOV
NHFOV is provided via binasal prongs. Ventilator settings:FiO2:21-40%,MAP：6-14 cm H2O,Hertz(HZ):5-10 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.
Device: NHFOV
For infants in the NHFOV-group who "fail"NHFOV (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.
Other Names:
  • SLE 5000

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intubation rate
Time Frame: 72 hours
endotracheal intubation rate assessed within 72 hours after extubation
72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
significant apnea
Time Frame: 7 days
significant apnea measured by Colin J definition:6 episodes requiring stimulation in 6 hours or requiring > 1episodes of positive ventilation
7 days
air leaks
Time Frame: 3 months
air leaks assessed by chest X-ray
3 months
Bronchopulmonary dysplasia
Time Frame: 3 months
Bronchopulmonary dysplasia assessed by national institute of child health and human development definition
3 months
necrotizing enterocolitis
Time Frame: 3 months
necrotizing enterocolitis assessed by abdominal X-ray and Bell classification
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gao WeiWei

Investigators

  • Study Director: yang jie, doctor, Guangdong Women and Children Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Anticipated)

August 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

August 21, 2015

First Submitted That Met QC Criteria

September 3, 2015

First Posted (Estimate)

September 7, 2015

Study Record Updates

Last Update Posted (Estimate)

February 24, 2016

Last Update Submitted That Met QC Criteria

February 22, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • guangdongwchhi4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Respiratory Insufficiency

Clinical Trials on NIPPV

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mozambique

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe