Effect of Reduced Noise Levels and Cycled Light on Visual and Neural Development in Preterm Infants
NCT ID: NCT02688010
Last Updated: 2020-02-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
109 participants
INTERVENTIONAL
2016-01-08
2019-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Control
No specific noise reduction strategies to restrict noise exposure less than 45 dB combined with either continuous bright light or continuous near darkness or unstructured combination of the two during the hospitalization.
No interventions assigned to this group
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).
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Infants with surgical issues
1 Day
7 Days
ALL
No
Sponsors
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Children's Hospital of Fudan University
OTHER
Responsible Party
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Principal Investigators
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Wenhao Zhou, Dr.
Role: STUDY_CHAIR
Key Laboratory of Neonatal Diseases, Ministry of Health
Locations
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Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Countries
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References
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Noise: a hazard for the fetus and newborn. American Academy of Pediatrics. Committee on Environmental Health. Pediatrics. 1997 Oct;100(4):724-7. No abstract available.
Lasky RE, Williams AL. Noise and light exposures for extremely low birth weight newborns during their stay in the neonatal intensive care unit. Pediatrics. 2009 Feb;123(2):540-6. doi: 10.1542/peds.2007-3418.
Laudert S, Liu WF, Blackington S, Perkins B, Martin S, Macmillan-York E, Graven S, Handyside J; NIC/Q 2005 Physical Environment Exploratory Group. Implementing potentially better practices to support the neurodevelopment of infants in the NICU. J Perinatol. 2007 Dec;27 Suppl 2:S75-93. doi: 10.1038/sj.jp.7211843.
Morag I, Ohlsson A. Cycled light in the intensive care unit for preterm and low birth weight infants. Cochrane Database Syst Rev. 2013 Aug 3;(8):CD006982. doi: 10.1002/14651858.CD006982.pub3.
Morag I, Xiao YT, Bruschettini M. Cycled light in the intensive care unit for preterm and low birth weight infants. Cochrane Database Syst Rev. 2024 Dec 19;12(12):CD006982. doi: 10.1002/14651858.CD006982.pub5.
Other Identifiers
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CHFudanU_NNICU7
Identifier Type: -
Identifier Source: org_study_id
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