A Study to Evaluate the Use of the Neotech RAM Nasal Cannula for CPAP and Bi-PAP Application in Infants 28-42 Weeks Gestation in a Neonatal Intensive Care Unit (NICU)

A Pilot Study to Evaluate the Use of the Neotech RAM Nasal Cannula for CPAP and Bi-PAP Application in Infants 28-42 Weeks Gestation in a Neonatal Intensive Care Unit (NICU)

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04096235

Enrollment

Registered

2019-09-19

Start date

2019-10-18

Completion date

2021-07-08

Last updated

2021-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Respiratory Distress

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.

Interventions

OTHERRAM Nasal Cannula

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

28 Weeks to 42 Weeks

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
NCPAP	5 days	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.
Bi-PAP	5 days	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.

Secondary

Measure	Time frame	Description
High Flow Humidity	5 days	The study will determine if the RAM Nasal Cannula administers high flow humidity (\>8Ipm) . 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026