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OpenTrials
Completed

NCT Number: NCT01748214

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.

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Key information

Age range

7 day and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Noise level

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Dec 12, 2012
Registry last updated
Dec 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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