Premature Infant Exposure to Noise Generated by Respiratory Support

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.

Study Overview

• Status: Completed
• Conditions: Premature Birth of Newborn

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 28

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University Of Virginia Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 week and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Infants born < 32 weeks, in an incubator, and > 7 days postnatal admitted to the Newborn Intensive Care Unit

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Nasal CPAP; Infants received nasal CPAP as standard of care.
High Flow Nasal Cannual; Infants received high flow nasal cannula as standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Virginia
• Investigators: Principal Investigator: Joshua Attridge, MD, UVA School of Medicine

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: December 6, 2012
• First Submitted That Met QC Criteria: December 10, 2012
• First Posted (Estimate): December 12, 2012

Study Record Updates

• Last Update Posted (Estimate): December 12, 2012
• Last Update Submitted That Met QC Criteria: December 10, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: preterm infants; high flow nasal cannula; continuous positive airway pressure; hearing outcomes; noise exposure
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: 13164