Preterm Infants: Light Effects on Health and Development
NCT ID: NCT02146287
Last Updated: 2017-03-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
121 participants
INTERVENTIONAL
2003-06-30
2008-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Effect of Cycled Light on Premature Infants and Mothers
NCT05010252
Compare of Effectiveness Cycled Light or Near Darkness on Growth Parameters in Preterm Infants
NCT02088359
Creating an Artificial Night on Physiological Changes in Preterm Infants
NCT01833091
Effect of Reduced Noise Levels and Cycled Light on Visual and Neural Development in Preterm Infants
NCT02688010
Cycled Phototherapy
NCT03927833
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Early Cycled Light
Infants received day night cycling of light on a 12-hour on and 12-hour off basis beginning at 28 weeks PMA
Cycled Light
Cycled light was provided in an 11-hour-on, 11-hour-off pattern. Daylight (240-700 lux) was provided with the incubator cover folded on top of the incubator allowing light in from four sides, or with the bassinet cover off during day hours (0730-1830). With the daylight range of 240-700 lux and limited access to natural light, excessive daylight was prevented.
Continuous near darkness was provided as (5-30 lux) throughout the day except from 0630-0730 and 1830-1930, when lighting levels varied based on nursing care needs at the change of shift. Near-darkness (5-30 lux) was provided by using incubator (totally covered or with the front flap back) and bassinet covers, and dimming individual bedside light during the day (0730-1830) and night hours (1930-0630).
Late Cycled Light
Infants received day night cycling of light on a 12-hour on and 12-hour off basis beginning at 36 weeks PMA
Cycled Light
Cycled light was provided in an 11-hour-on, 11-hour-off pattern. Daylight (240-700 lux) was provided with the incubator cover folded on top of the incubator allowing light in from four sides, or with the bassinet cover off during day hours (0730-1830). With the daylight range of 240-700 lux and limited access to natural light, excessive daylight was prevented.
Continuous near darkness was provided as (5-30 lux) throughout the day except from 0630-0730 and 1830-1930, when lighting levels varied based on nursing care needs at the change of shift. Near-darkness (5-30 lux) was provided by using incubator (totally covered or with the front flap back) and bassinet covers, and dimming individual bedside light during the day (0730-1830) and night hours (1930-0630).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cycled Light
Cycled light was provided in an 11-hour-on, 11-hour-off pattern. Daylight (240-700 lux) was provided with the incubator cover folded on top of the incubator allowing light in from four sides, or with the bassinet cover off during day hours (0730-1830). With the daylight range of 240-700 lux and limited access to natural light, excessive daylight was prevented.
Continuous near darkness was provided as (5-30 lux) throughout the day except from 0630-0730 and 1830-1930, when lighting levels varied based on nursing care needs at the change of shift. Near-darkness (5-30 lux) was provided by using incubator (totally covered or with the front flap back) and bassinet covers, and dimming individual bedside light during the day (0730-1830) and night hours (1930-0630).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
23 Weeks
28 Weeks
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Nursing Research (NINR)
NIH
Duke University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Debra H Brandon, PhD
Role: PRINCIPAL_INVESTIGATOR
Duke University School of Nursing
References
Explore related publications, articles, or registry entries linked to this study.
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.
Park J, Knafl G, Thoyre S, Brandon D. Factors associated with feeding progression in extremely preterm infants. Nurs Res. 2015 May-Jun;64(3):159-67. doi: 10.1097/NNR.0000000000000093.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Pro00011520
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.