search
Back to results

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

Primary Purpose

Preterm Infants

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Noise reduction and cycled light
Sponsored by
Children's Hospital of Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Preterm Infants focused on measuring noise, sound, cycled light, preterm infants, neonatal care, growth, visual development

Eligibility Criteria

1 Day - 7 Days (Child)All SexesDoes not accept 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

Sites / Locations

  • Children's Hospital of Fudan University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Noise reduction and cycled light

Arm 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.

Reduced noise exposure (sound levels <45 dB) and cycled light (approximately 12 hours of light on and 12 hours of light off).

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Time to establish full enteral feeding
up to 3 months
Weight at discharge
up to 3 months
Head circumferences at discharge
Incidence of nosocomial infection
Incidence of retinopathy of prematurity
Incidence of intraventricular hemorrhage
Incidence of bronchopulmonary dysplasia

Full Information

First Posted
January 30, 2016
Last Updated
February 12, 2020
Sponsor
Children's Hospital of Fudan University
search

1. Study Identification

Unique Protocol Identification Number
NCT02688010
Brief Title
Effect of Reduced Noise Levels and Cycled Light on Visual and Neural Development in Preterm Infants
Official Title
Effect of Reduced Noise Levels and Cycled Light on Visual and Neural Development in Preterm Infants
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
January 8, 2016 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Fudan University

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Infants
Keywords
noise, sound, cycled light, preterm infants, neonatal care, growth, visual development

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
109 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm 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.
Arm Title
Noise reduction and cycled light
Arm Type
Experimental
Arm Description
Reduced noise exposure (sound levels <45 dB) and cycled light (approximately 12 hours of light on and 12 hours of light off).
Intervention Type
Behavioral
Intervention Name(s)
Noise reduction and cycled light
Intervention Description
Reduced noise exposure (sound levels <45 dB) and cycled light (approximately 12 hours of light on and 12 hours of light off).
Primary Outcome Measure Information:
Title
Flash visual evoked potentials (FVEP) at 4 weeks of age
Description
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.
Time Frame
at 4 weeks of age
Title
Bayley Scales of Infant Development, Second Edition (BSID-III) at 18 months of age
Description
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.
Time Frame
at 18 months of age
Secondary Outcome Measure Information:
Title
Time to establish full enteral feeding
Description
up to 3 months
Time Frame
birth till discharge from hospital (up to 3 months)
Title
Weight at discharge
Description
up to 3 months
Time Frame
birth till discharge from hospital (up to 3 months)
Title
Head circumferences at discharge
Time Frame
up to 3 months
Title
Incidence of nosocomial infection
Time Frame
up to 3 months
Title
Incidence of retinopathy of prematurity
Time Frame
up to 3 months
Title
Incidence of intraventricular hemorrhage
Time Frame
1 month
Title
Incidence of bronchopulmonary dysplasia
Time Frame
at corrected gestational age of 36 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
7 Days
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wenhao Zhou, Dr.
Organizational Affiliation
Key Laboratory of Neonatal Diseases, Ministry of Health
Official's Role
Study Chair
Facility Information:
Facility Name
Children's Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201102
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
9836852
Citation
Noise: a hazard for the fetus and newborn. American Academy of Pediatrics. Committee on Environmental Health. Pediatrics. 1997 Oct;100(4):724-7. No abstract available.
Results Reference
result
PubMed Identifier
19171620
Citation
Lasky RE, Williams AL. Noise and light exposures for extremely low birth weight newborns during their stay in the neonatal intensive care unit. Pediatrics. 2009 Feb;123(2):540-6. doi: 10.1542/peds.2007-3418.
Results Reference
result
PubMed Identifier
18034183
Citation
Laudert S, Liu WF, Blackington S, Perkins B, Martin S, Macmillan-York E, Graven S, Handyside J; NIC/Q 2005 Physical Environment Exploratory Group. Implementing potentially better practices to support the neurodevelopment of infants in the NICU. J Perinatol. 2007 Dec;27 Suppl 2:S75-93. doi: 10.1038/sj.jp.7211843.
Results Reference
result
PubMed Identifier
23913547
Citation
Morag I, Ohlsson A. Cycled light in the intensive care unit for preterm and low birth weight infants. Cochrane Database Syst Rev. 2013 Aug 3;(8):CD006982. doi: 10.1002/14651858.CD006982.pub3.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs