NHFOV vs NIPPV vs nCPAP in Preterm Infants With Respiratory Distress Syndrome
1 other identifier
interventional
684
1 country
8
Brief Summary
This will be a prospective, multi-center, three-arms,parallel, randomized, controlled trial with a superiority design,conducted in China. The investigators conduct this multi-centre, randomized, controlled trial to test the hypothesis that NHFOV is more effective than nCPAP or NIPPV in the treatment of respiratory distress syndrome (RDS) in infants with a gestational age of less than 30 weeks or a birth weight of less than 1500g when used as a primary noninvasive ventilation (NIV) mode.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2020
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 31, 2019
CompletedFirst Posted
Study publicly available on registry
February 15, 2019
CompletedStudy Start
First participant enrolled
November 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 21, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 21, 2022
CompletedNovember 18, 2020
November 1, 2020
1.6 years
January 31, 2019
November 16, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
treatment failure within 72 hours after randomization 72 hours after randomization
need for invasive mechanical ventilation
within 72 hours after randomization
Secondary Outcomes (5)
Rate of airleaks(pneumothorax and/or pneumomediastinum) occurred during noninvasive respiratory support
during noninvasive respiratory support
Rate of bronchopulmonary dysplasia
36 weeks of postmenstrual age
Rate of retinopathy of prematurity (ROP)
Within 6 months after birth
Rate of necrotizing enterocolitis (NEC)
through study completion, an average of 1 year
Rate of intraventricular hemorrhage
through study completion, an average of 1 year
Other Outcomes (7)
Rate of thick secretions causing an airway obstruction.
during noninvasive respiratory support
days of hospitalization
through study completion, an average of 1 year
duration of noninvasive respiratory support
duration of noninvasive respiratory support
- +4 more other outcomes
Study Arms (3)
nCPAP
ACTIVE COMPARATORneonates assigned to the nCPAP group will be started on a pressure of 6 cmH2O( adjust range:6-8 cmH2O) by pure CPAP system , with FiO2 (0.21～0.40)adjusted to target SpO2 from 89% to 94%
NIPPV
ACTIVE COMPARATORneonates assigned to the NIPPV group will be started with the following parameters: a) positive end-expiratory pressure (PEEP) of 4 cmH2O (can be raised in steps of 1 cmH2O to max 8 cmH2O, according to the oxygenation).b)Peak Inspiratory Pressure (PIP) of15 cmH2O (can be raised in steps of 1 cmH2O to max 25 cmH2O, according to oxygenation,PaCO2 levels and the chest expansion); maximal allowed FiO2 will be 0.40 and SpO2 targets will be 90-95%. c) inspiratory time (IT) will be 0.45 - 0.5 sec (according to clinicians'evaluation of leaks and the appearance of the pressure curve: a small pressure plateau is required and flow may be set accordingly) and rate will be started at30 bpm (can be raised in steps of 5 bpm to max 50 bpm, according to PaCO2 levels).
NHFOV
EXPERIMENTAL\- neonates assigned to NHFOV will be started with the following boundaries, according to available physiological and mechanical data, as suggested elsewhere: a) Paw of 10 cmH2O (can be changed in steps of 1 cmH2O within the range range 5- 16cmH2O); Paw will be titrated (within the range) according to open lung strategy, performing alveolar recruitment. Maximal allowed FiO2 will be 0.40 and SpO2 targets will be 89%-94%. b) frequency of 10Hz(can be changed in steps of 1Hz within the range 8-15Hz). c)Inspiratory time 50% (1:1).\[ d)amplitude 25 cmH2O(can be changed in steps of 5 cmH2O within the range 25-50 cmH2O); amplitude will be titrated according to PaCO2.
Interventions
Eligibility Criteria
You may qualify if:
- Gestational age (GA) of less than 30 weeks or birth weight less than 1500g
- Clinical diagnose of RDS
- Parental consent
You may not qualify if:
- Intubated for resuscitation or for other reasons at birth
- Major congenital malformations or known complex congenital heart disease
- No parental consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400042, China
Chongqing Women and Children Health Hospital
Chongqing, Chongqing Municipality, 401120, China
Chongqing Three Gorges Central Hospital
Chongqing, Chongqing Municipality, 404100, China
Guiyang Maternity and Child Health Care Hospital
Guiyang, Guizhou, 550000, China
Zhengzhou Children's Hospital
Zhengzhou, Henan, 450000, China
Hunan Children's Hospital
Changsha, Hunan, 410000, China
Chengdu Women and Children's Central Hospital
Chengdu, Sichuan, 610000, China
Kunming Children's Hospital, Kunming
Kunming, Yunnan, 650000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Yuan Shi, PhD
Children's Hospital of Chongqing Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
January 31, 2019
First Posted
February 15, 2019
Study Start
November 1, 2020
Primary Completion
May 21, 2022
Study Completion
May 21, 2022
Last Updated
November 18, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share