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Completed

NCT Number: NCT02688010

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

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.

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Key information

Conditions

Age range

1 day–7 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Noise reduction and cycled light

Behavioral

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Feb 23, 2016
Registry last updated
Feb 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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