CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 109 enrolled
Drug / intervention
Noise reduction and cycled lightbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02688010
NCT02688010N/ACompleted
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Effect of Reduced Noise Levels and Cycled Light on Visual and Neural Development in Preterm Infants

Children's Hospital of Fudan University·interventional·Posted Feb 23, 2016·Updated Feb 17, 2020

In Brief

A clinical study evaluating Noise reduction and cycled light for Preterm Infants. Completed, enrolled 109 participants across 1 site.

Detailed Summary

Noise is a hazard for newborn. In 1997, the American Academy of Pediatrics determined that safe sound levels in the neonatal intensive care unit (NICU) should not exceed 45 dB which has been rarely achieved. High intensities of noise have several negative effects on preterm newborns. Also, they are exposed to either continuous bright light continuous near darkness or unstructured combination of the two during their hospitalizations. The investigators primary objective is to determine the impact of reduced noise levels and cycled light on growth parameters and visual development in preterm infants.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPreterm Infants
CountriesChina
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 23, 2016
Enrollment StartJan 8, 2016
Primary CompletionDec 31, 2019
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 10.4 years ago

Interventions

Noise reduction and cycled lightbehavioral

Reduced noise exposure (sound levels \<45 dB) and cycled light (approximately 12 hours of light on and 12 hours of light off).