NCT03081611

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
166

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 16, 2017

Completed
10 months until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2020

Completed
Last Updated

February 18, 2020

Status Verified

February 1, 2020

Enrollment Period

2 years

First QC Date

March 12, 2017

Last Update Submit

February 15, 2020

Conditions

Respiratory Distress Syndrome, NewbornNoninvasive VentilationInfant, PrematureIntubation, Intratracheal

Outcome Measures

Primary Outcomes (1)

  • intubation

    The need for intubation

    72 hours

Secondary Outcomes (1)

  • nasal trauma

    during NIPPV procedure

Study Arms (2)

Ram cannula

EXPERIMENTAL

NIPPV VIA Ram cannula

Device: Ram cannula

Short nasal prongs

ACTIVE COMPARATOR

NIPPV VIA short nasal prongs

Device: Short nasal prongs

Interventions

Ram cannulaDEVICE

Ventilatory support for preterm infants using Ram cannula

Ram cannula
Short nasal prongsDEVICE

Ventilatory support for preterm infants using short nasal prongs

Short nasal prongs

Eligibility Criteria

AgeUp to 28 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Medical Center

Haifa, 31096, Israel

Location

Related Publications (1)

  • 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.

    PMID: 33165539DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome, NewbornPremature Birth

Condition Hierarchy (Ancestors)

Respiratory Distress SyndromeLung DiseasesRespiratory Tract DiseasesRespiration DisordersInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Ori Hochwald, MD

    NICU, Rambam Medical Center, Haifa, Israel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Not possible
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Non Inferiority Randomized Control Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 12, 2017

First Posted

March 16, 2017

Study Start

January 1, 2018

Primary Completion

December 30, 2019

Study Completion

January 30, 2020

Last Updated

February 18, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)