Premature Infant Exposure to Noise Generated by Respiratory Support

Completed

• Conditions: Premature Birth of Newborn

• Registration Number: NCT01748214
• Lead Sponsor: University of Virginia

Brief 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.

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 Timeline

• Study Start: 2008-11
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2012-12
• Study First Submitted: 2012-12-06
• Study First Submitted QC: 2012-12-10
• Last Update Submitted: 2012-12-10
• Study First Posted: 2012-12-12
• Last Update Posted: 2012-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Noise level	6 days	Noise levels will be measured during a set time while infants are on Nasal CPAP and Nasal High flow cannula as standard of care

Trial Locations

Locations (1)

University of Virginia Health System; 🇺🇸 Charlottesville, Virginia, United States