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

Study Overview
=================
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.

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

Conditions
-----------------
Preterm Infants

Intervention / Treatment
-----------------
* Behavioral: Noise reduction and cycled light


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 7 Days

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>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<br>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<br>* Reduced noise exposure (sound levels <45 dB) and cycled light (approximately 12 hours of light on and 12 hours of light off).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flash visual evoked potentials (FVEP) 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. | at 4 weeks of age | 
| Bayley Scales of Infant Development, Second Edition (BSID-III) 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. | at 18 months of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to establish full enteral feeding | up to 3 months | birth till discharge from hospital (up to 3 months) | 
| Weight at discharge | up to 3 months | birth till discharge from hospital (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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
noise, sound, cycled light, preterm infants, neonatal care, growth, visual development