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

Respiratory Distress Syndrome, Newborn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02168257
• Other study ID #: 1303-032
• Secondary ID: 47575
• Status: Terminated
• Phase: N/A
• First received: June 18, 2014
• Last updated: July 18, 2017
• Start date: June 2014
• Est. completion date: February 2017

Study information

• Verified date: July 2017
• Source: Children's Hospitals and Clinics of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• RAM Cannula

• Binasal Prong CPAP

Locations

Country	Name	City	State
United States	Children's Hospitals and Clinics of Minnesota	Saint Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospitals and Clinics of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pulse		3 hrs
Other	Respiratory Rate		3 hrs
Other	Blood Pressure		3 hrs
Other	Oxygen requirement	Measured by fraction of inspired oxygen to maintain target pulse oximetry saturation.	3 hrs
Primary	Oxygenation	Pulse oximetry	3 hrs
Primary	Ventilation	transcutaneous carbon dioxide monitor	3 hrs
Secondary	Esophageal pressure measurements	Esophageal Pressure Catheter	3 hrs
Secondary	Apnea	3-channel pneumogram	3 hrs