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

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Fudan University

Status

Completed

Conditions

Preterm Infants

Treatments

Behavioral: Noise reduction and cycled light

Study type

Interventional

Funder types

Other

Identifiers

NCT02688010
CHFudanU_NNICU7

Details and patient eligibility

About

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.

Enrollment

109 patients

Sex

All

Ages

1 to 7 days old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • <37 gestational weeks preterm infants and >1250g birth weight

Exclusion criteria

  • Major congenital anomaly and infection prior to enrolment
  • Infants with surgical issues

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

109 participants in 2 patient groups

Control
No Intervention group
Description:
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.
Noise reduction and cycled light
Experimental group
Description:
Reduced noise exposure (sound levels <45 dB) and cycled light (approximately 12 hours of light on and 12 hours of light off).
Treatment:
Behavioral: Noise reduction and cycled light

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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