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)

Englewood Hospital and Medical Center

Status: Terminated

Conditions: Neonatal Respiratory Distress

Treatments: Other: RAM Nasal Cannula

Study type: Interventional

Funder types: Other

Identifiers

NCT04096235

E-19-763

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 28 to 42 weeks old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

RAM Cannula

Experimental group

Treatment:

Other: RAM Nasal Cannula