High Flow Nasal Cannula (HFNC) Versus Nasal Intermittent Mandatory Ventilation (NIMV)for Respiratory Distress Syndrome (RDS): a Randomized, Controlled, Prospective Study
NCT ID: NCT01189162
Last Updated: 2015-08-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2010-01-31
2016-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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NIMV- nasal respiratory support
Infants with RDS will be treateg with nasal intermittent mandatory ventilation
NIMV with SLE ventilator vs HFNC via Vapotherm
Nasal respiratory support for RDS
HFNC- nasal respiratory support with HFNC
Infants with RDS will be treated with nasal respiratory support with high flow nasal canulla
NIMV with SLE ventilator vs HFNC via Vapotherm
Nasal respiratory support for RDS
Interventions
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NIMV with SLE ventilator vs HFNC via Vapotherm
Nasal respiratory support for RDS
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Infants with RDS who will need NRS as initial therapy or after extubation and for apnea of prematurity, 3. written informed consent.
Exclusion Criteria
2. Parents refuse consent.
3. Unavailability of suitable ventilator.
1 Minute
ALL
No
Sponsors
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Bnai Zion Medical Center
OTHER_GOV
Responsible Party
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Principal Investigators
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Amir Kugelman, MD
Role: PRINCIPAL_INVESTIGATOR
Bnai Zion Medical Cente
Locations
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Bnai Zion Medical Center, Neonatal department
Haifa, , Israel
Countries
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Facility Contacts
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Amir Kugelman, MD
Role: primary
References
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Kugelman A, Feferkorn I, Riskin A, Chistyakov I, Kaufman B, Bader D. Nasal intermittent mandatory ventilation versus nasal continuous positive airway pressure for respiratory distress syndrome: a randomized, controlled, prospective study. J Pediatr. 2007 May;150(5):521-6, 526.e1. doi: 10.1016/j.jpeds.2007.01.032.
Kugelman A, Riskin A, Said W, Shoris I, Mor F, Bader D. A randomized pilot study comparing heated humidified high-flow nasal cannulae with NIPPV for RDS. Pediatr Pulmonol. 2015 Jun;50(6):576-83. doi: 10.1002/ppul.23022. Epub 2014 Mar 12.
Other Identifiers
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31/09
Identifier Type: -
Identifier Source: org_study_id
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