Premature Birth of NewbornNCT01748214
Premature Infant Exposure to Noise Generated by Respiratory Support
An observational study of Premature Birth of Newborn, run by University of Virginia at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 7 days and older
- Conditions the study is for
- Premature Birth of Newborn
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Nov 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 days and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Infants born < 32 weeks, in an incubator, and > 7 days postnatal admitted to the Newborn Intensive Care Unit
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia Health System
Charlottesville, Virginia, 22908
About this study
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.
Read the 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.
- Conditions
- Premature Birth of Newborn
- Keywords
- continuous positive airway pressure, high flow nasal cannula, hearing outcomes, noise exposure, preterm infants
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Nasal CPAP | Infants received nasal CPAP as standard of care. | |
| High Flow Nasal Cannual | Infants received high flow nasal cannula as standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2012 (estimated)
- Study startNov 2008
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Birth of NewbornStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Swanson, MD, University of Virginia
- Investigators
- Joshua Attridge, MD, Principal investigator, UVA School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01748214
- Sponsor's protocol ID
- 13164
- Status last verified
- Dec 2012
- First submitted
- 6 Dec 2012
- Last updated
- 12 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Premature Infant Exposure to Noise Generated by Respiratory Support
- ClinicalTrials.gov ID
- NCT01748214
- Acronym / sponsor ID
- 13164
- Conditions
- Premature Birth of Newborn
- Keywords
- continuous positive airway pressure, high flow nasal cannula, hearing outcomes, noise exposure, preterm infants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 12 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nasal CPAP | – | –Infants received nasal CPAP as standard of care. |
| High Flow Nasal Cannual | – | –Infants received high flow nasal cannula as standard of care. |
Who may qualify
- Ages
- 7 days and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Infants born < 32 weeks, in an incubator, and > 7 days postnatal admitted to the Newborn Intensive Care Unit
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joshua Attridge, MD principal investigator
UVA School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Birth of Newborn, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Noise level (time frame: 6 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2012.