NCT03366714

Brief Summary

Noninvasive ventilation defines methods of providing ventilation support with constant or variable pressure using nasal or nasopharyngeal interfaces without endotracheal intubation or tracheostomy. Today, short binasal prongs and different types of nasal masks are the most commonly used nasal interfaces in the NICU with the aim of providing NIV. RAM cannula (Neotech ™, Valencia, CA), a new nasal interface, is increasingly used in NID applications in newborn infants. The RAM cannula is available in the inspiration and expiration arms of the stroke while reducing the dead space in the respiratory tract due to the low nasal prong diameter. There are not enough studies comparing the effectiveness of the RAM cannula with other short binasal prongs or nasal masks. Investigators compared the effectiveness and nasal injury rates of RAM cannula and short binasal prong as NIV interfaces in preterm infants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2017

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

Study Start

First participant enrolled

April 1, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 8, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2018

Completed
Last Updated

February 19, 2020

Status Verified

February 1, 2020

Enrollment Period

1.2 years

First QC Date

November 24, 2017

Last Update Submit

February 18, 2020

Conditions

Respiratory Distress Syndrome, Newborn

Keywords

Noninvasive ventilation, respiratory distress syndrome

Outcome Measures

Primary Outcomes (1)

  • Nasal IPPV failure

    Non invasive ventilation failure in patients who underwent nasal IPPV with RAM cannula

    up to four weeks

Secondary Outcomes (1)

  • NİV duration

    up to two months

Study Arms (2)

RAM cannula

EXPERIMENTAL

nasal CPAP support with RAM cannula

Device: nasal CPAP support with RAM cannula

Hudson cannula (short binasal cannula)

ACTIVE COMPARATOR

nasal CPAP support with Hudson cannula

Device: nasal CPAP support with Hudson cannula

Interventions

nasal CPAP support with RAM cannulaDEVICE

Patients with respiratory distress syndrome who do not need intubation in the delivery room. This groub will be provided with non-invasive respiratory support RAM cannula.

RAM cannula
nasal CPAP support with Hudson cannulaDEVICE

Patients with respiratory distress syndrome who do not need intubation in the delivery room. This groub will be provided with non-invasive respiratory support Hudson cannula.

Hudson cannula (short binasal cannula)

Eligibility Criteria

Age1 Minute - 15 Minutes
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • gestational age between 26-34 weeks and,
  • born in our hospital and,
  • Patients with clinical findings (tachypnea, groaning, chest retractions) of RDS

You may not qualify if:

  • Patients who needed intubation to stabilize in the delivery room or who had severe congenital anomalies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turgut Özal Medical Center

Malatya, 44280, Turkey (Türkiye)

Location

Related Publications (3)

  • Davis P, Davies M, Faber B. A randomised controlled trial of two methods of delivering nasal continuous positive airway pressure after extubation to infants weighing less than 1000 g: binasal (Hudson) versus single nasal prongs. Arch Dis Child Fetal Neonatal Ed. 2001 Sep;85(2):F82-5. doi: 10.1136/fn.85.2.f82.

    PMID: 11517198BACKGROUND

  • Gerdes JS, Sivieri EM, Abbasi S. Factors influencing delivered mean airway pressure during nasal CPAP with the RAM cannula. Pediatr Pulmonol. 2016 Jan;51(1):60-9. doi: 10.1002/ppul.23197. Epub 2015 Apr 7.

    PMID: 25851534BACKGROUND

  • Nzegwu NI, Mack T, DellaVentura R, Dunphy L, Koval N, Levit O, Bhandari V. Systematic use of the RAM nasal cannula in the Yale-New Haven Children's Hospital Neonatal Intensive Care Unit: a quality improvement project. J Matern Fetal Neonatal Med. 2015 Apr;28(6):718-21. doi: 10.3109/14767058.2014.929659. Epub 2014 Jun 30.

    PMID: 24874561RESULT

MeSH Terms

Conditions

Respiratory Distress Syndrome, NewbornRespiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration DisordersInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Departman of Pediatrics, Division of Neonatoloji

Study Record Dates

First Submitted

November 24, 2017

First Posted

December 8, 2017

Study Start

April 1, 2017

Primary Completion

June 1, 2018

Study Completion

August 15, 2018

Last Updated

February 19, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)