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

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

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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