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Status unknownNCT01189162Updated Aug 13, 2015

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

An interventional study of NIMV with SLE ventilator vs HFNC via Vapotherm in Respiratory Distress Syndrome, sponsored by Bnai Zion Medical Center. Status unknown at 1 site in Israel. Open to participants aged 1 Minute and older. Per ClinicalTrials.gov, last updated 2015-08-13.

Sponsored by Bnai Zion Medical Center · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
1 Minute and older
Sex
All
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Study 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.

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Conditions studied

  • Respiratory Distress Syndrome

Keywords

  • Primary treatment of RDS and treatment of RDS post extubation
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In context

Respiratory Distress Syndrome

1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.

This study's planned enrollment of 80 is above the median of 60 across 961 interventional studies indexed under Respiratory Distress Syndrome.

Browse Respiratory Distress Syndrome studies →

Lead sponsor

Bnai Zion Medical Center is the lead sponsor of 102 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Minute and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • DeviceNIMV with SLE ventilator vs HFNC via Vapotherm

    Nasal respiratory support for RDS

    Also known as: NIMV with SLE ventilator vs. HFNC via Vapotherm

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What researchers measure

Primary outcomes

  1. 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 outcomes

  1. 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"

    Time frame: 1 year

  2. % 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.

    Time frame: 1 year

  3. % 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

    Time frame: 1 year

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Study locations

1 of 1 sites recruiting
  • Bnai Zion Medical Center, Neonatal department
    Haifa, Israel
    • Amir Kugelman, MD · Contact · 972-4-8359559
    • Amir Kugelman, MD · Principal investigator
    Recruiting
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References and documents

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 17452229 ↗
  • 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. PubMed 24619945 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01189162
Lead sponsor
Bnai Zion Medical Center
Responsible party
Sponsor
First posted
Aug 26, 2010
Start date
Jan 2010
Primary completion
Jul 2016 (estimated)
Completion
Jul 2016 (estimated)
Last update
Aug 13, 2015

Study contacts

Amir Kugelman, MD
principal investigator · Bnai Zion Medical Cente

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.

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