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Effect of Reduced Noise Levels and Cycled Light on Visual and Neural Development in Preterm Infants

NCT02688010 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 109

Last updated 2020-02-17

No results posted yet for this study

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.

Conditions

  • Preterm Infants

Interventions

BEHAVIORAL

Noise reduction and cycled light

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

Sponsors & Collaborators

  • Children's Hospital of Fudan University

    lead OTHER

Principal Investigators

  • Wenhao Zhou, Dr. · Key Laboratory of Neonatal Diseases, Ministry of Health

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
7 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-08
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02688010 on ClinicalTrials.gov