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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

Primary Purpose

Respiratory Distress Syndrome

Status

Unknown status

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

NIMV with SLE ventilator vs HFNC via Vapotherm

About this trial

This is an interventional treatment trial for Respiratory Distress Syndrome focused on measuring Primary treatment of RDS and treatment of RDS post extubation

Eligibility Criteria

1 Minute - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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
Infants with RDS who will need NRS as initial therapy or after extubation and for apnea of prematurity, 3. written informed consent.

Exclusion Criteria:

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),
Parents refuse consent.
Unavailability of suitable ventilator.

Sites / Locations

Bnai Zion Medical Center, Neonatal departmentRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

NIMV- nasal respiratory support

HFNC- nasal respiratory support with HFNC

Arm Description

Infants with RDS will be treateg with nasal intermittent mandatory ventilation

Infants with RDS will be treated with nasal respiratory support with high flow nasal canulla

Outcomes

Primary Outcome Measures

The percent of infants who will fail NRS and need endotracheal ventilation or will be switched to another mode of NRS.

Secondary Outcome Measures

Clinical features on both methods

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

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

Nasal trauma due to NRS, rate of air leak (pneumothorax), gastrointestinal perforation, irritability and discomfort assessed by a validated score

Full Information

NCT ID

NCT01189162

First Posted

August 23, 2010

Last Updated

August 11, 2015

Sponsor

Bnai Zion Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01189162

Brief Title

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

Official Title

High Flow Nasal Cannula Versus Nasal Intermittent Mandatory Ventilation for Respiratory Distress Syndrome: a Randomized, Controlled, Prospective Study

Study Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Unknown status

Study Start Date

January 2010 (undefined)

Primary Completion Date

July 2016 (Anticipated)

Study Completion Date

July 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bnai Zion Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Respiratory Distress Syndrome

Keywords

Primary treatment of RDS and treatment of RDS post extubation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

NIMV- nasal respiratory support

Arm Type

Experimental

Arm Description

Infants with RDS will be treateg with nasal intermittent mandatory ventilation

Arm Title

HFNC- nasal respiratory support with HFNC

Arm Type

Experimental

Arm Description

Infants with RDS will be treated with nasal respiratory support with high flow nasal canulla

Intervention Type

Device

Intervention Name(s)

NIMV with SLE ventilator vs HFNC via Vapotherm

Other Intervention Name(s)

NIMV with SLE ventilator vs. HFNC via Vapotherm

Intervention Description

Nasal respiratory support for RDS

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Clinical features on both methods

Description

Time Frame

1 year

Title

% of infants with neonatal morbidities on both methods

Description

Time Frame

1 year

Title

% of infants with possible side effects on both methods

Description

Nasal trauma due to NRS, rate of air leak (pneumothorax), gastrointestinal perforation, irritability and discomfort assessed by a validated score

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Minute

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Infants with RDS who will need NRS as initial therapy or after extubation and for apnea of prematurity, 3. written informed consent. Exclusion Criteria: 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), Parents refuse consent. Unavailability of suitable ventilator.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Amir Kugelman, MD

Organizational Affiliation

Bnai Zion Medical Cente

Official's Role

Principal Investigator

Facility Information:

Facility Name

Bnai Zion Medical Center, Neonatal department

City

Haifa

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Amir Kugelman, MD

Phone

972-4-8359559

First Name & Middle Initial & Last Name & Degree

Amir Kugelman, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

17452229

Citation

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.

Results Reference

background

PubMed Identifier

24619945

Citation

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.

Results Reference

derived

Learn more about this trial

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

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