CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 340 enrolled
Drug / intervention
noninvasive high-frequency ventilation (nHFOV) +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03099694
NCT03099694N/ACompleted
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Noninvasive Ventilation for Preterm Neonates With Respiratory Distress Syndrome: a Multi-center Randomized Controlled Trial

Xingwang Zhu·interventional·Posted Apr 4, 2017·Updated Mar 2, 2021

In Brief

A clinical study evaluating noninvasive high-frequency ventilation (nHFOV) and nasal continuous positive airway pressure (nCPAP) for Preterm Infants. Completed, enrolled 340 participants across 1 site.

Detailed Summary

The investigators compared advantages and disadvantages of two forms of noninvasive respiratory support -noninvasive high-frequency oscillatory ventilation (nHFOV) or nasal continuous positive airway pressure (nCPAP) -as a primary mode of ventilation in premature infants with RDS．

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPreterm Infants
CountriesChina
CollaboratorsGuiyang Maternity and Child Health Care Hospital, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University, Children's Hospital of Chongqing Medical University, Chongqing Maternal and Child Health Hospital, The Second Hospital of Shandong University, Yan'an Affiliated Hospital of Kunming Medical University, The Children's Hospital of Zhejiang University School of Medicine, Hunan Children's Hospital, Zhengzhou Children's Hospital, China, Chengdu Women's and Children's Central Hospital, The People's Hospital of Dehong Autonomous Prefecture, Kunming Children's Hospital, Chongqing Three Gorges Central Hospital, Shanxi Provincial Maternity and Children's Hospital, University of Southern California, Vilnius University, Children's Hospital of Fudan University, Guangdong Women and Children Hospital, Nanjing Children's Hospital

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedApr 4, 2017
Enrollment StartApr 27, 2017
Primary CompletionJul 28, 2018
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 9.2 years ago

Interventions

noninvasive high-frequency ventilation (nHFOV)procedure

NHFOV will be provided by a high frequency ventilator (CNO, Medin, Germany or SLE 5000, UK). NHFOV will be provided via binasal prongs.

nasal continuous positive airway pressure (nCPAP)procedure

Infants assigned to the NCPAP group will be started on a pressure of 6 cmH2O (range: 6-8 cmH2O) by CPAP system (CNO Medin, Germany, Carefusion, USA)