RAM Cannula VS Short Nasal Prongs for Delivering NIPPV in Preterm Infants

NCT ID: NCT03081611

Last Updated: 2020-02-18

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

COMPLETED

Clinical Phase

NA

Total Enrollment

166 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2020-01-30

Brief Summary

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Randomized control trial, Ram cannula VS short nasal prongs for delivering Non Invasive Positive Pressure Ventilation (NIPPV) for preterm infants

Detailed Description

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Randomized control trial comparing Ram cannula to the regular, more investigated short nasal prongs for delivering Non Invasive Positive Pressure Ventilation (NIPPV) for preterm infants with respiratory distress.

Conditions

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Respiratory Distress Syndrome, Newborn Noninvasive Ventilation Infant, Premature Intubation, Intratracheal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Non Inferiority Randomized Control Trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Not possible

Study Groups

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Ram cannula

NIPPV VIA Ram cannula

Group Type EXPERIMENTAL

Ram cannula

Intervention Type DEVICE

Ventilatory support for preterm infants using Ram cannula

Short nasal prongs

NIPPV VIA short nasal prongs

Group Type ACTIVE_COMPARATOR

Short nasal prongs

Intervention Type DEVICE

Ventilatory support for preterm infants using short nasal prongs

Interventions

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Ram cannula

Ventilatory support for preterm infants using Ram cannula

Intervention Type DEVICE

Short nasal prongs

Ventilatory support for preterm infants using short nasal prongs

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Gestational age 24-33.6
* Physician decision on the need for non invasive ventilation
* parental consent

Exclusion Criteria

* Pneumothorax before recruitment
* Significant congenital heart disease or chromosomal disorder
Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

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Ori Hochwald , MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ori Hochwald, MD

Role: PRINCIPAL_INVESTIGATOR

NICU, Rambam Medical Center, Haifa, Israel

Locations

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Rambam Medical Center

Haifa, , Israel

Site Status

Countries

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Israel

References

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Hochwald O, Riskin A, Borenstein-Levin L, Shoris I, Dinur GP, Said W, Jubran H, Littner Y, Haddad J, Mor M, Timstut F, Bader D, Kugelman A. Cannula With Long and Narrow Tubing vs Short Binasal Prongs for Noninvasive Ventilation in Preterm Infants: Noninferiority Randomized Clinical Trial. JAMA Pediatr. 2021 Jan 1;175(1):36-43. doi: 10.1001/jamapediatrics.2020.3579.

Reference Type DERIVED
PMID: 33165539 (View on PubMed)

Other Identifiers

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RAMCAN

Identifier Type: -

Identifier Source: org_study_id

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