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How Different Levels of CPAP Affect Oxygen Delivery and Lung Expansion in Preterm Infants

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University of Arkansas

Status

Enrolling

Conditions

Respiratory Distress Syndrome (Neonatal)
Respiratory Distress of Newborn

Treatments

Device: Effective oxygen delivery and lung expansion measurement

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

With this study, it is expected to learn more about preterm babies on breathing support with nasal continuous positive airway pressure (nCPAP). To gain more information on how much oxygen is actually delivered to the baby from the nCPAP machine.

Full description

This study will tell more about a specific method of breathing support used frequently with preterm babies called nasal continuous positive airway pressure (nCPAP). It helps the baby breathe by providing air pressure and a certain amount of oxygen. It is very important for the baby's health to provide only as much oxygen as they need.

With this study, it is expected to learn if the amount of oxygen ordered by a doctor on the nCPAP machine changes when it reaches the baby's airway, and if the amount of oxygen changes depending on how much air pressure the doctor provides. The answers to these questions, are not known, because special measurements are required that are difficult to know while a baby is on nCPAP. This study will collect these special measurements

Enrollment

10 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Gestational age at birth must be less than 35 weeks of completed gestation as documented in the subject's initial history and physical
  • The infant must be stable while receiving nasal CPAP at any pressure level at the time of study
  • The infant must be receiving 22-40% at the time of the study

Exclusion criteria

  • Oxygen requirements greater than 40% at time of enrollment
  • currently receiving invasive ventilation or not requiring ventilatory support
  • Major congenital anomalies of the heart and/or lungs

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

Infants on nCPAP
Experimental group
Description:
All infants on CPAP will have a catheter placed in their oropharynx to measure delivered oxygen and a soft band placed around the infant's chest to measure lung expansion.
Treatment:
Device: Effective oxygen delivery and lung expansion measurement

Trial contacts and locations

1

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Central trial contact

Nicholas A Rowley, MD

Data sourced from clinicaltrials.gov

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