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

February 12, 2020 updated by: Children's Hospital of Fudan University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

109

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 201102
        • Children's Hospital of Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 1 week (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Flash visual evoked potentials (FVEP) at 4 weeks of age
Time Frame: 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
Time Frame: 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
Time Frame: birth till discharge from hospital (up to 3 months)
up to 3 months
birth till discharge from hospital (up to 3 months)
Weight at discharge
Time Frame: birth till discharge from hospital (up to 3 months)
up to 3 months
birth till discharge from hospital (up to 3 months)
Head circumferences at discharge
Time Frame: up to 3 months
up to 3 months
Incidence of nosocomial infection
Time Frame: up to 3 months
up to 3 months
Incidence of retinopathy of prematurity
Time Frame: up to 3 months
up to 3 months
Incidence of intraventricular hemorrhage
Time Frame: 1 month
1 month
Incidence of bronchopulmonary dysplasia
Time Frame: at corrected gestational age of 36 weeks
at corrected gestational age of 36 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital of Fudan University

Investigators

  • Study Chair: Wenhao Zhou, Dr., Key Laboratory of Neonatal Diseases, Ministry of Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 8, 2016

Primary Completion (ACTUAL)

December 31, 2019

Study Completion (ACTUAL)

December 31, 2019

Study Registration Dates

First Submitted

January 30, 2016

First Submitted That Met QC Criteria

February 22, 2016

First Posted (ESTIMATE)

February 23, 2016

Study Record Updates

Last Update Posted (ACTUAL)

February 17, 2020

Last Update Submitted That Met QC Criteria

February 12, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHFudanU_NNICU7

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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