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

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2016-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Respiratory Distress Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NIMV- nasal respiratory support

Infants with RDS will be treateg with nasal intermittent mandatory ventilation

Group Type EXPERIMENTAL

NIMV with SLE ventilator vs HFNC via Vapotherm

Intervention Type DEVICE

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

Group Type EXPERIMENTAL

NIMV with SLE ventilator vs HFNC via Vapotherm

Intervention Type DEVICE

Nasal respiratory support for RDS

Interventions

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NIMV with SLE ventilator vs HFNC via Vapotherm

Nasal respiratory support for RDS

Intervention Type DEVICE

Other Intervention Names

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NIMV with SLE ventilator vs. HFNC via Vapotherm

Eligibility Criteria

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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.
Minimum Eligible Age

1 Minute

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bnai Zion Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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Israel

Facility Contacts

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Amir Kugelman, MD

Role: primary

972-4-8359559

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.

Reference Type BACKGROUND
PMID: 17452229 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24619945 (View on PubMed)

Other Identifiers

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31/09

Identifier Type: -

Identifier Source: org_study_id

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