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CompletedNCT03081611RAMCANUpdated Feb 18, 2020

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

An interventional study of Ram cannula and Short nasal prongs in Respiratory Distress Syndrome, Newborn, Noninvasive Ventilation and Infant, Premature, sponsored by Rambam Health Care Campus. Completed at 1 site in Israel. Open to participants aged Up to 28 Days. Per ClinicalTrials.gov, last updated 2020-02-18.

Sponsored by Rambam Health Care Campus · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
166
Allocation
Randomized
Ages
Up to 28 Days
Sex
All
01

Study summary

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

Read the detailed description

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.

02

Conditions studied

  • Respiratory Distress Syndrome, Newborn
  • Noninvasive Ventilation
  • Infant, Premature
  • Intubation, Intratracheal
03

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 enrollment of 166 is above the median of 60 across 961 interventional studies indexed under Respiratory Distress Syndrome.

Browse Respiratory Distress Syndrome studies →

Lead sponsor

Rambam Health Care Campus is the lead sponsor of 456 studies on the registry; 33 are open to participants now.

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

04

Who can participate

Ages eligible
Up to 28 Days
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Pneumothorax before recruitment
  • Significant congenital heart disease or chromosomal disorder
05

Study design

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

Study arms

  • Experimental
    Ram cannula

    NIPPV VIA Ram cannula

    Device: Ram cannula

  • Active comparator
    Short nasal prongs

    NIPPV VIA short nasal prongs

    Device: Short nasal prongs

Interventions

  • DeviceRam cannula

    Ventilatory support for preterm infants using Ram cannula

  • DeviceShort nasal prongs

    Ventilatory support for preterm infants using short nasal prongs

06

What researchers measure

Primary outcomes

  1. intubation

    The need for intubation

    Time frame: 72 hours

Secondary outcomes

  1. nasal trauma

    nasal trauma

    Time frame: during NIPPV procedure

07

Study locations

1 site
  • Rambam Medical Center
    Haifa, 31096, Israel
08

References and documents

Publications

  • 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. PubMed 33165539 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 18, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03081611
Lead sponsor
Rambam Health Care Campus
Responsible party
Ori Hochwald , MD (Principal Investigator, Rambam Health Care Campus) — Principal investigator
First posted
Mar 16, 2017
Start date
Jan 1, 2018
Primary completion
Dec 30, 2019
Completion
Jan 30, 2020
Last update
Feb 18, 2020

Study contacts

Ori Hochwald, MD
principal investigator · NICU, Rambam Medical Center, Haifa, Israel

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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