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Trial record 9 of 23 for:    Recruiting, Not yet recruiting, Available Studies | "Noise"

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

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ClinicalTrials.gov Identifier: NCT02688010
Recruitment Status : Recruiting
First Posted : February 23, 2016
Last Update Posted : January 26, 2018
Sponsor:
Information provided by (Responsible Party):
Children's Hospital of Fudan University

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 Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 154 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
Study Start Date : January 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Noise

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).




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Time to establish full enteral feeding [ Time Frame: birth till discharge from hospital (up to 3 months) ]
    up to 3 months

  2. Weight at discharge [ Time Frame: birth till discharge from hospital (up to 3 months) ]
    up to 3 months

  3. Head circumferences at discharge [ Time Frame: up to 3 months ]
  4. Incidence of nosocomial infection [ Time Frame: up to 3 months ]
  5. Incidence of retinopathy of prematurity [ Time Frame: up to 3 months ]
  6. Incidence of intraventricular hemorrhage [ Time Frame: 1 month ]
  7. Incidence of bronchopulmonary dysplasia [ Time Frame: at corrected gestational age of 36 weeks ]


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Ages Eligible for Study:   up to 7 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02688010


Contacts
Contact: Wenhao Zhou, Dr. zwhchu@126.com
Contact: Liyuan Hu, Dr. nowadays921@126.com

Locations
China, Shanghai
Children's Hospital of Fudan University Recruiting
Shanghai, Shanghai, China, 201102
Contact: Liyuan Hu, MD    +86-13816060888    nowadays921@126.com   
Contact: Wenhao Zhou, PhD    +86-21-64931003    zhwchfu@126.com   
Sponsors and Collaborators
Children's Hospital of Fudan University
Investigators
Study Chair: Wenhao Zhou, Dr. Key Laboratory of Neonatal Diseases, Ministry of Health