NCT04096235

Brief Summary

This study will explore the RAM Nasal Cannula as a means of providing CPAP and Bi-PAP to infants 28-42 weeks gestation to prevent nasal septal erosion.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 19, 2019

Completed
29 days until next milestone

Study Start

First participant enrolled

October 18, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 8, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2021

Completed
Last Updated

August 20, 2021

Status Verified

August 1, 2021

Enrollment Period

1.7 years

First QC Date

September 16, 2019

Last Update Submit

August 16, 2021

Conditions

Neonatal Respiratory Distress

Outcome Measures

Primary Outcomes (6)

  • NCPAP

    The study will determine if the RAM Nasal Cannula is providing adequate CPAP to neonates. This will be measured with the Braden Q score. The Braden Q Scale is composed of seven subscales. All seven subscales are rated from 1 (least favorable)to4(most favorable); patients receive only one score per subscale.

    5 days

  • Bi-PAP

    The study will determine if the RAM Nasal Cannula is providing adequate Bi-PAP to neonates. This will be measured with the Braden Q score every 3 hours. The Braden Q Scale is composed of seven subscales. All seven subscales are rated from 1 (least favorable)to4(most favorable); patients receive only one score per subscale.

    5 days

  • NCPAP

    The study will determine if the RAM Nasal Cannula is providing adequate CPAP to neonates. This will be measured with SpO2 Level every 3 hours. The SpO2 will be measured in percentage

    5 days

  • NCPAP

    The study will determine if the RAM Nasal Cannula is providing adequate CPAP to neonates. This will be measured with Pulse Oximetry Level every 3 hours. The pulse oximetry is measured in millimeters

    5 days

  • Bi-PAP

    The study will determine if the RAM Nasal Cannula is providing adequate Bi-PAP to neonates. This will be measured with SpO2 Level every 3 hours. The SpO2 will be measured in percentage

    5 days

  • Bi-PAP

    The study will determine if the RAM Nasal Cannula is providing adequate Bi-PAP to neonates. This will be measured with Pulse Oximetry Level every 3 hours. The pulse oximetry is measured in millimeters

    5 days

Secondary Outcomes (3)

  • High Flow Humidity

    5 days

  • High Flow Humidity

    5 days

  • High Flow Humidity

    5 days

Study Arms (1)

RAM Cannula

EXPERIMENTAL
Other: RAM Nasal Cannula

Interventions

RAM Nasal CannulaOTHER

The RAM Nasal Cannula is a means of providing CPAP and Bi-PAP to infants 28-42 weeks gestation to prevent nasal septal erosion.

RAM Cannula

Eligibility Criteria

Age28 Weeks - 42 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Infants with birth weight \< 1500 grams AND/OR \<32 weeks gestational age
  • Infants between 34-42 weeks gestational age and exclusive breastfeeding with no risk of nasal septal erosion OR Infants between 28-42 weeks gestational age at risk of nasal septal erosion

You may not qualify if:

  • Infants with major congenital and upper airway anomalies
  • Infants requiring ETT (endotracheal tube) mechanical ventilation
  • Infants receiving no respiratory support

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Englewood Hospital and Medical Center

Englewood, New Jersey, 07631, United States

Location

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2019

First Posted

September 19, 2019

Study Start

October 18, 2019

Primary Completion

July 8, 2021

Study Completion

July 8, 2021

Last Updated

August 20, 2021

Record last verified: 2021-08

Locations

US(1)