Respiratory Distress SyndromeNCT01189162
High Flow Nasal Cannula (HFNC) Versus Nasal Intermittent Mandatory Ventilation (NIMV)for Respiratory Distress Syndrome (RDS): a Randomized, Controlled, Prospective Study
A study testing NIMV with SLE ventilator vs HFNC via Vapotherm in people with Respiratory Distress Syndrome, run by Bnai Zion Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 minute and older
- Conditions the study is for
- Respiratory Distress Syndrome
- What is being tested?
- NIMV with SLE ventilator vs HFNC via Vapotherm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2010to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Bnai Zion Medical Center, Neonatal department
Haifa
Amir Kugelman, MD, 972-4-8359559
Amir Kugelman, MD
About this study
Official title: High Flow Nasal Cannula Versus Nasal Intermittent Mandatory Ventilation for Respiratory Distress Syndrome: a Randomized, Controlled, Prospective Study
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.
- Conditions
- Respiratory Distress Syndrome
- Being tested
- NIMV with SLE ventilator vs HFNC via Vapotherm
- Keywords
- Primary treatment of RDS and treatment of RDS post extubation
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIMV with SLE ventilator vs HFNC via VapothermDevice
Also called NIMV with SLE ventilator vs. HFNC via Vapotherm
Nasal respiratory support for RDS
| Study group | Role | What they receive |
|---|---|---|
| NIMV- nasal respiratory support | Experimental | Infants with RDS will be treateg with nasal intermittent mandatory ventilation Receives: Device: NIMV with SLE ventilator vs HFNC via Vapotherm |
| HFNC- nasal respiratory support with HFNC | Experimental | Infants with RDS will be treated with nasal respiratory support with high flow nasal canulla Receives: Device: NIMV with SLE ventilator vs HFNC via Vapotherm |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percent of infants who will fail NRS and need endotracheal ventilation or will be switched to another mode of NRS.
Measured: 1 year
Secondary outcomes (3)
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"
Measured: 1 year
% 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.
Measured: 1 year
% 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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2010 (estimated)
- Study startJan 2010
- Primary completionJul 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bnai Zion Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Amir Kugelman, MD, Principal investigator, Bnai Zion Medical Cente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01189162
- Sponsor's protocol ID
- 31/09
- Status last verified
- Aug 2015
- First submitted
- 23 Aug 2010
- Last updated
- 13 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17452229Kugelman 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.
PubMed 24619945
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Flow Nasal Cannula Versus Nasal Intermittent Mandatory Ventilation for Respiratory Distress Syndrome: a Randomized, Controlled, Prospective Study
- ClinicalTrials.gov ID
- NCT01189162
- Acronym / sponsor ID
- 31/09
- Conditions
- Respiratory Distress Syndrome
- Keywords
- Primary treatment of RDS and treatment of RDS post extubation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Bnai Zion Medical CenterOther government
- Study start
- Jan 2010
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 26 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NIMV- nasal respiratory support | Experimental | Device: NIMV with SLE ventilator vs HFNC via VapothermInfants with RDS will be treateg with nasal intermittent mandatory ventilation |
| HFNC- nasal respiratory support with HFNC | Experimental | Device: NIMV with SLE ventilator vs HFNC via VapothermInfants with RDS will be treated with nasal respiratory support with high flow nasal canulla |
Who may qualify
- Ages
- 1 minute and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIMV with SLE ventilator vs HFNC via VapothermAlso: NIMV with SLE ventilator vs. HFNC via VapothermNasal respiratory support for RDS | Device | HFNC- nasal respiratory support with HFNC, NIMV- nasal respiratory support |
Primary outcome
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
3 secondary outcomes
Clinical features on both methods
Time frame: 1 year
% of infants with neonatal morbidities on both methods
Time frame: 1 year
% of infants with possible side effects on both methods
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2015.
- Background: PubMed 17452229Kugelman 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.
- Derived from this study: PubMed 24619945Kugelman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amir Kugelman, MD principal investigator
Bnai Zion Medical Cente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NIMV with SLE ventilator vs HFNC via Vapotherm in people with Respiratory Distress Syndrome, run by Bnai Zion Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01189162, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2015.