Premature Infant Exposure to Noise Generated by Respiratory Support

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

COMPLETED

Total Enrollment

28 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-11-30

Study Completion Date

2010-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Premature Birth of Newborn

Keywords

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continuous positive airway pressure high flow nasal cannula hearing outcomes noise exposure preterm infants

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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Nasal CPAP

Infants received nasal CPAP as standard of care.

No interventions assigned to this group

High Flow Nasal Cannual

Infants received high flow nasal cannula as standard of care.

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

7 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Jonathan Swanson, MD

Prinicipal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joshua Attridge, MD

Role: PRINCIPAL_INVESTIGATOR

UVA School of Medicine

Locations

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University of Virginia Health System

Charlottesville, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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13164

Identifier Type: -

Identifier Source: org_study_id