Clinical trial NCT01748214: Premature Infant Exposure to Noise Generated by Respiratory Support
Official title: Premature Infant Exposure to Noise Generated by Respiratory Support
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Premature Birth of Newborn
Keywords: continuous positive airway pressure
high flow nasal cannula
hearing outcomes
noise exposure
preterm infants
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2012-12-12
Enrollment: 28
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Noise level
timeFrame: 6 days
Secondary outcomes:
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
Study officials:
affiliation: UVA School of Medicine
name: Joshua Attridge, MD
role: PRINCIPAL_INVESTIGATOR
References: