Premature Infant Exposure to Noise Generated by Respiratory Support

NCT01748214 | Completed

• 1 other identifier: 13164
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Birth of Newborn

Keywords

continuous positive airway pressure; high flow nasal cannula; hearing outcomes; noise exposure; preterm infants

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Nasal CPAP

Infants received nasal CPAP as standard of care.

High Flow Nasal Cannual

Infants received high flow nasal cannula as standard of care.

Eligibility Criteria

• Age: 7 Days+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Joshua Attridge, MD

  UVA School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: December 6, 2012
• First Posted: December 12, 2012
• Study Start: November 1, 2008
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: December 12, 2012

Record last verified: 2012-12

Locations

US (1)