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High Flow Nasal Cannula (HFNC) Versus Nasal Intermittent Mandatory Ventilation (NIMV)for Respiratory Distress Syndrome (RDS): a Randomized, Controlled, Prospective Study

This study is currently recruiting participants.
Verified May 2013 by Bnai Zion Medical Center
Sponsor:
Information provided by (Responsible Party):
Bnai Zion Medical Center
ClinicalTrials.gov Identifier:
NCT01189162
First received: August 23, 2010
Last updated: May 16, 2013
Last verified: May 2013
History of Changes
  Purpose

The investigators hypothesize that while the extremely low birthweight (ELBW) infants (<1000 g) may need NIMV for the treatment of RDS, larger infants or the smaller ones post extubation may enjoy the comfort benefits associated with HFNC while getting coparable respiratory support to NIMV.


Condition Intervention
Respiratory Distress Syndrome
 Device: NIMV with SLE ventilator vs HFNC via Vapotherm

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: High Flow Nasal Cannula Versus Nasal Intermittent Mandatory Ventilation for Respiratory Distress Syndrome: a Randomized, Controlled, Prospective Study

Further study details as provided by Bnai Zion Medical Center:

Primary Outcome Measures:
  • The percent of infants who will fail NRS and need endotracheal ventilation or will be switched to another mode of NRS. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical features on both methods [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Blood pressure, heart rate, respiratory rate, pulse oximetry saturation, and respiratory status prior to mechanical ventilation if needed according to arterial blood gas (PaO2, PCO2, pH), and "time to stop nasal support"

  • % of infants with neonatal morbidities on both methods [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Incidence of intraventricular hemorrhage (IVH), duration of mechanical ventilation, incidence of BPD (oxygen at 36 weeks post conceptional age to keep saturation>92%), time until full feeds, and length of stay.

  • % of infants with possible side effects on both methods [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Nasal trauma due to NRS, rate of air leak (pneumothorax), gastrointestinal perforation, irritability and discomfort assessed by a validated score


Estimated Enrollment: 80
Study Start Date: January 2010
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NIMV- nasal respiratory support
Infants with RDS will be treateg with nasal intermittent mandatory ventilation
 Device: NIMV with SLE ventilator vs HFNC via Vapotherm
Nasal respiratory support for RDS
Other Name: NIMV with SLE ventilator vs. HFNC via Vapotherm
Experimental: HFNC- nasal respiratory support with HFNC
Infants with RDS will be treated with nasal respiratory support with high flow nasal canulla
 Device: NIMV with SLE ventilator vs HFNC via Vapotherm
Nasal respiratory support for RDS
Other Name: NIMV with SLE ventilator vs. HFNC via Vapotherm

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Gestational age between 24 to 34 and 6/7 weeks assessed by the obstetrical team from dating of last menstural period or ultrasound and weight >1000 g for the initial treatment of RDS or <35 weeks post extubation or for apnea of prematurity
  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:

  1. Significant morbidity apart from RDS including: cardiac disease (not including patent ductus arteriosus [PDA]), congenital malformation, or if they had cardiovascular or respiratory instability because of sepsis, anemia or severe intraventricular hemorrhage (IVH),
  2. Parents refuse consent.
  3. Unavailability of suitable ventilator.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01189162

Locations
Israel
Bnai Zion Medical Center, Neonatal department Recruiting
Haifa, Israel
Contact: Amir Kugelman, MD     972-4-8359559        
Principal Investigator: Amir Kugelman, MD            
Sponsors and Collaborators
Bnai Zion Medical Center
Investigators
Principal Investigator: Amir Kugelman, MD Bnai Zion Medical Cente
  More Information

Publications:

Responsible Party: Bnai Zion Medical Center
ClinicalTrials.gov Identifier: NCT01189162     History of Changes
Other Study ID Numbers: 31/09
Study First Received: August 23, 2010
Last Updated: May 16, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Bnai Zion Medical Center:
Primary treatment of RDS and treatment of RDS post extubation

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases
 Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on May 16, 2013