Clinical trial NCT02688010: 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
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Infants
Keywords: noise
sound
cycled light
preterm infants
neonatal care
growth
visual development
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2016-02-23
Enrollment: 109
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Flash visual evoked potentials (FVEP) at 4 weeks of age
timeFrame: at 4 weeks of age
measure: Bayley Scales of Infant Development, Second Edition (BSID-III) at 18 months of age
timeFrame: at 18 months of age
Secondary outcomes:
measure: Time to establish full enteral feeding
timeFrame: birth till discharge from hospital (up to 3 months)
measure: Weight at discharge
timeFrame: birth till discharge from hospital (up to 3 months)
measure: Head circumferences at discharge
timeFrame: up to 3 months
measure: Incidence of nosocomial infection
timeFrame: up to 3 months
measure: Incidence of retinopathy of prematurity
timeFrame: up to 3 months
measure: Incidence of intraventricular hemorrhage
timeFrame: 1 month
measure: Incidence of bronchopulmonary dysplasia
timeFrame: at corrected gestational age of 36 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Key Laboratory of Neonatal Diseases, Ministry of Health
name: Wenhao Zhou, Dr.
role: STUDY_CHAIR
References:
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.
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.
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.
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.