Premature Infant Exposure to Noise Generated by Respiratory Support

Premature Birth of Newborn Clinical Trial

Official title:

Premature Infant Exposure to Noise Generated by Respiratory Support

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01748214
• Other study ID #: 13164
• 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

• Premature Birth
• Premature Birth of Newborn

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