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

Sponsor

Children's Hospital of Fudan University (Other)

Overall Status

Completed

CT.gov ID

NCT02688010

Collaborator

(none)

109

Enrollment

Location

Arms

47.7

Actual Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Preterm Infants	Behavioral: Noise reduction and cycled light	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

109 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jan 8, 2016

Actual Primary Completion Date :

Dec 31, 2019

Actual Study Completion Date :

Dec 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: 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.
Experimental: 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).	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).

Arm

Intervention/Treatment

No Intervention: 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.

Experimental: 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).

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).

Outcome Measures

Primary Outcome Measures

Flash visual evoked potentials (FVEP) at 4 weeks of age [at 4 weeks of age]
FVEP is recorded from each eye individually after they fall asleep. Three silver-sliver chloride electrodes are placed according to 10-20 International system with active electrode at Oz (1-2 cm above inion), reference electrode at Fz and ground electrode at Cz. Scalp-electrode impedance is usually below 5kΩ but always below 10kΩ. Flash stimulus (2 Hz.) is given by light emitting diode goggles simulator at a distance of 2 cm to one eye at a time. 100 responses are averaged for each eye automatically in the Nicolet Viking Quest visual electrophysiological device at 1s total sweep time. Band pass filters are set at 0.1-75 Hz. The reproducibility of the responses is ensured by repeating the test two or more times. Responses with excessive artifacts are automatically rejected. The parameters of P1, N1, P2, N2, P3, and N3 of the FVEP are stored and subsequently assessed by ophthalmologist blinded to the infant's clinical course.
Bayley Scales of Infant Development, Second Edition (BSID-III) at 18 months of age [at 18 months of age]
Neurodevelopment outcome is measured with the Bayley Scales of Infant Development, Second Edition (BSID-III) at corrected gestational age of 18 month, assessed by the physician from department of child health care who was blinded with respect to the subjects. Mental and motor scores were calculated by the BSID-III Mental Developmental Index (MDI) and Psychomotor Developmental Index (PDI). The subject's neurodevelopmental outcome was classified as delayed if either score was less than 70.

Secondary Outcome Measures

Time to establish full enteral feeding [birth till discharge from hospital (up to 3 months)]
up to 3 months
Weight at discharge [birth till discharge from hospital (up to 3 months)]
up to 3 months
Head circumferences at discharge [up to 3 months]
Incidence of nosocomial infection [up to 3 months]
Incidence of retinopathy of prematurity [up to 3 months]
Incidence of intraventricular hemorrhage [1 month]
Incidence of bronchopulmonary dysplasia [at corrected gestational age of 36 weeks]