Neotech RAM Cannula Versus Conventional Binasal Prong Continuous Positive Airway Pressure (CPAP) to Treat Respiratory Distress in Low Birth Weight Neonates

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2017-02-28

Brief Summary

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The purpose of this study is to determine if the RAM cannula is as effective as conventional binasal prongs to deliver CPAP to low birth weight infants with respiratory distress.

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Detailed Description

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Conditions

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Respiratory Distress Syndrome, Newborn Continuous Positive Airway Pressure Low Birth Weight Infants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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RAM Cannula CPAP

CPAP provided by RAM Cannula

Group Type EXPERIMENTAL

RAM Cannula

Intervention Type DEVICE

Binasal Prong CPAP

CPAP provided by binasal prong

Group Type ACTIVE_COMPARATOR

Binasal Prong CPAP

Intervention Type DEVICE

Interventions

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RAM Cannula

Intervention Type DEVICE

Binasal Prong CPAP

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Low Birth Weight Infant
* Currently on continuous positive aireway pressure of 5-7 cm water pressure
* Receiving continuous positive airway pressure support for \> 24 hrs prior to enrollment
* Fraction of inspired oxygen requirement of 23-50%

Exclusion Criteria

* Fraction of inspired oxygen \> 50%
* Congenital defects of head, pulmonary or cardiovascular systems
* Chromosomal abnormalities/genetic syndromes
* Invasive Surgical Procedure within 24 hrs prior to enrollment
* Enrollment in separate clinical trial that has ongoing data collection

Eligible Sex

ALL

Accepts Healthy Volunteers

No