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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01748214
Other study ID # 13164
Secondary ID
Status Completed
Phase N/A
First received December 6, 2012
Last updated December 10, 2012
Start date November 2008
Est. completion date November 2010

Study information

Verified date December 2012
Source University of Virginia
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

Infants in neonatal intensive care units are increasing exposed to non-invasive ventilatory support modes (nasal continuous positive airway pressure - NCPAP and high flow nasal cannula: >1 L/min flow - HFNC). While there have been small descriptive studies of noise exposure in infants on NCPAP, there have been no comparative trials done comparing noise exposure in infants undergoing both NCPAP and HFNC.

Objective: Using a cross-over model determine noise exposure levels in infants exposed to similar levels of respiratory support provided by NCPAP and HFNC.


Description:

Infants born < 32 weeks, in an incubator, and > 7 days postnatal that were maintained on either on NCPAP or HFNC to maintain SaO2 in a range of 88 - 92 %. Study infants had decibel measurements obtained every 15 seconds for 30 minutes using a noise dosimeter (NoisePro DLX-1). The microphone for the dosimeter was suspended from the inside of the incubator such that it hung 1 foot above the infants nose and mouth. The exhalation port for NCPAP was placed outside of the incubator. Repeated measurement periods on the same mode of support were made within a 72 hour period. Each infant the acted as their own control and was switched within 7 days to the alternative respiratory support method that maintained similar SaO2 goals and repeat measurements were obtained. Comparisons of mean decibel levels during recording were compared using paired t-tests.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date November 2010
Est. primary completion date November 2010
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Premature infant born < 32 weeks and 0 days post-conceptional age;

- Seven or more days of age and not in acute respiratory distress;

- Need for nasal continuous positive airway pressure or high-flow nasal cannula for ventilation or supplemental oxygen delivery;

- In a neutral-thermal environment (i.e. isolette)

Exclusion Criteria:

- Oro-facial congenital anomalies;

- Congenital heart disease (except for patent ductus arteriosus and/or patent foramen ovale);

- Unstable respiratory status as deemed by the attending physician

- Patients under isolation for infectious disease

Study Design

Observational Model: Case-Crossover, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States University of Virginia Health System Charlottesville Virginia

Sponsors (1)

Lead Sponsor Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Noise level Noise levels will be measured during a set time while infants are on Nasal CPAP and Nasal High flow cannula as standard of care 6 days No
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