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

Preterm Infants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02688010
• Other study ID #: CHFudanU_NNICU7
• Status: Completed
• Phase: N/A
• Start date: January 8, 2016
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2020
• Source: Children's Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 7 Days

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Preterm Infants

Intervention

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).

Locations

Country	Name	City	State
China	Children's Hospital of Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View 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 Perinato — View 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. Review. Update in: Cochrane Database Syst Rev. 2016;8:CD006982. — View Citation

Noise: a hazard for the fetus and newborn. American Academy of Pediatrics. Committee on Environmental Health. Pediatrics. 1997 Oct;100(4):724-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 5kO but always below 10kO. 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
Primary	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	Time to establish full enteral feeding	up to 3 months	birth till discharge from hospital (up to 3 months)
Secondary	Weight at discharge	up to 3 months	birth till discharge from hospital (up to 3 months)
Secondary	Head circumferences at discharge		up to 3 months
Secondary	Incidence of nosocomial infection		up to 3 months
Secondary	Incidence of retinopathy of prematurity		up to 3 months
Secondary	Incidence of intraventricular hemorrhage		1 month
Secondary	Incidence of bronchopulmonary dysplasia		at corrected gestational age of 36 weeks