- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02146287
Preterm Infants: Light Effects on Health and Development
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Infants were < 7 days of age and were born at 28 weeks or < 28 weeks
Exclusion Criteria:
- known anomalies associated with neurological or visual problems (e.g., congenital glaucoma, Down Syndrome)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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 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). |
Active Comparator: 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 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). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Infant weight gain trajectory
Time Frame: weekly inpatient up to 52 weeks post menstral age (PMA) and at outpatient visits to 18 months
|
This measure was single blinded.
|
weekly inpatient up to 52 weeks post menstral age (PMA) and at outpatient visits to 18 months
|
Change in sleep development during hospitalization
Time Frame: Every three weeks up to 52 weeks PMA
|
Change in the developmental pattern of four sleep wake states (active, quiet, transition, awake) were evaluated during hospitalization.
|
Every three weeks up to 52 weeks PMA
|
Change in sleep development after discharge home
Time Frame: Every 5 months following hospital discharge up to 24 months PMA
|
Change in the development of sleep and wake bouts were evaluated following hospital discharge until the infant reached 24 months PMA
|
Every 5 months following hospital discharge up to 24 months PMA
|
Mental Development
Time Frame: 9 months PMA
|
Mental development was measured using the Bayley Scales of Infant Development.
|
9 months PMA
|
Psychomotor Development
Time Frame: 9 months PMA
|
Psychomotor Development was measured using the Bayley Scales of Infant Development
|
9 months PMA
|
Mental Development
Time Frame: 18 months PMA
|
Mental development was measured using the Bayley Scales of Infant Development.
|
18 months PMA
|
Psychomotor Development
Time Frame: 18 months PMA
|
Psychomotor Development was measured using the Bayley Scales of Infant Development
|
18 months PMA
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Length of Hospitalization in Days
Time Frame: At hospital discharge from 0 to 222 days
|
Length of hospitalization from birth until discharge home.
|
At hospital discharge from 0 to 222 days
|
Severity of Retinopathy of Prematurity (ROP)
Time Frame: Up to 52 weeks
|
ROP change over time and degree of severity was assessed until 24 months PMA
|
Up to 52 weeks
|
visual acuity
Time Frame: Measures at 12 months PMA
|
Measures at 12 months PMA
|
|
Neurological development
Time Frame: 9 months PMA
|
Neurological development was assessed by a neurological exam as either normal, suspect or abnormal and the presence of absence of Cerebral Palsy
|
9 months PMA
|
Brainstorm Auditory Evoked Potentials
Time Frame: 6 months
|
6 months
|
|
Neurological development
Time Frame: 18 months PMA
|
Neurological development was assessed by a neurological exam as either normal, suspect or abnormal and the presence of absence of Cerebral Palsy
|
18 months PMA
|
Change in Retinopathy of Prematurity (ROP)
Time Frame: Every two weeks during hospitalization after 30 weeks PMA up to 52 weeks PMA and during outpatient visits up to 24 months PMA
|
ROP change over time and degree of severity was assessed until 24 months PMA
|
Every two weeks during hospitalization after 30 weeks PMA up to 52 weeks PMA and during outpatient visits up to 24 months PMA
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Debra H Brandon, PhD, Duke University School of Nursing
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00011520
- R01NR008044 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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