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

NCT02688010 | Completed DMC

• 1 other identifier: CHFudanU_NNICU7
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Infants

Keywords

noise; sound; cycled light; preterm infants; neonatal care; growth; visual development

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Time to establish full enteral feeding

  birth till discharge from hospital (up to 3 months)

• Weight at discharge

  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

Study Arms (2)

Control

NO INTERVENTION

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.

Noise reduction and cycled light

EXPERIMENTAL

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

Interventions

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).

Noise reduction and cycled light

Eligibility Criteria

• Age: 1 Day - 7 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \<37 gestational weeks preterm infants and \>1250g birth weight

You may not qualify if:

• Major congenital anomaly and infection prior to enrolment
• Infants with surgical issues

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

Location

Related Publications (5)

• 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.

  PMID: 9836852 RESULT

• 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.

  PMID: 19171620 RESULT

• 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.

  PMID: 18034183 RESULT

• 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.

  PMID: 23913547 RESULT

• Morag I, Xiao YT, Bruschettini M. Cycled light in the intensive care unit for preterm and low birth weight infants. Cochrane Database Syst Rev. 2024 Dec 19;12(12):CD006982. doi: 10.1002/14651858.CD006982.pub5.

  PMID: 39699174 DERIVED

Study Officials

• Wenhao Zhou, Dr.

  Key Laboratory of Neonatal Diseases, Ministry of Health

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2016
• First Posted: February 23, 2016
• Study Start: January 8, 2016
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: February 17, 2020

Record last verified: 2020-02

Locations

CN (1)