Preterm Infants: Light Effects on Health and Development
Primary Purpose
Preterm Infant Health, Preterm Infant Development
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cycled Light
Sponsored by

About this trial
This is an interventional treatment trial for Preterm Infant Health focused on measuring cycled light, preterm infants, infant neurodevelopment, infant sleep
Eligibility Criteria
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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Early Cycled Light
Late Cycled Light
Arm Description
Infants received day night cycling of light on a 12-hour on and 12-hour off basis beginning at 28 weeks PMA
Infants received day night cycling of light on a 12-hour on and 12-hour off basis beginning at 36 weeks PMA
Outcomes
Primary Outcome Measures
Infant weight gain trajectory
This measure was single blinded.
Change in sleep development during hospitalization
Change in the developmental pattern of four sleep wake states (active, quiet, transition, awake) were evaluated during hospitalization.
Change in sleep development after discharge home
Change in the development of sleep and wake bouts were evaluated following hospital discharge until the infant reached 24 months PMA
Mental Development
Mental development was measured using the Bayley Scales of Infant Development.
Psychomotor Development
Psychomotor Development was measured using the Bayley Scales of Infant Development
Mental Development
Mental development was measured using the Bayley Scales of Infant Development.
Psychomotor Development
Psychomotor Development was measured using the Bayley Scales of Infant Development
Secondary Outcome Measures
Length of Hospitalization in Days
Length of hospitalization from birth until discharge home.
Severity of Retinopathy of Prematurity (ROP)
ROP change over time and degree of severity was assessed until 24 months PMA
visual acuity
Neurological development
Neurological development was assessed by a neurological exam as either normal, suspect or abnormal and the presence of absence of Cerebral Palsy
Brainstorm Auditory Evoked Potentials
Neurological development
Neurological development was assessed by a neurological exam as either normal, suspect or abnormal and the presence of absence of Cerebral Palsy
Change in Retinopathy of Prematurity (ROP)
ROP change over time and degree of severity was assessed until 24 months PMA
Full Information
NCT ID
NCT02146287
First Posted
May 21, 2014
Last Updated
March 27, 2017
Sponsor
Duke University
Collaborators
National Institute of Nursing Research (NINR)
1. Study Identification
Unique Protocol Identification Number
NCT02146287
Brief Title
Preterm Infants: Light Effects on Health and Development
Official Title
Preterm Infants: Light Effects on Health and Development
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Institute of Nursing Research (NINR)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Preterm babies cared for in the intensive care nursery are exposed to amounts of light that are very different from the exposures to an unborn baby or the newborn term baby. Currently many nurseries try to protect premature babies from too much light. They may also try to create light conditions of day and night like many parent homes. Some studies have shown improvements in health and development of babies cared for in nurseries that try to change light for premature babies.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Infant Health, Preterm Infant Development
Keywords
cycled light, preterm infants, infant neurodevelopment, infant sleep
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
121 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Early Cycled Light
Arm Type
Active Comparator
Arm Description
Infants received day night cycling of light on a 12-hour on and 12-hour off basis beginning at 28 weeks PMA
Arm Title
Late Cycled Light
Arm Type
Active Comparator
Arm Description
Infants received day night cycling of light on a 12-hour on and 12-hour off basis beginning at 36 weeks PMA
Intervention Type
Other
Intervention Name(s)
Cycled Light
Intervention Description
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).
Primary Outcome Measure Information:
Title
Infant weight gain trajectory
Description
This measure was single blinded.
Time Frame
weekly inpatient up to 52 weeks post menstral age (PMA) and at outpatient visits to 18 months
Title
Change in sleep development during hospitalization
Description
Change in the developmental pattern of four sleep wake states (active, quiet, transition, awake) were evaluated during hospitalization.
Time Frame
Every three weeks up to 52 weeks PMA
Title
Change in sleep development after discharge home
Description
Change in the development of sleep and wake bouts were evaluated following hospital discharge until the infant reached 24 months PMA
Time Frame
Every 5 months following hospital discharge up to 24 months PMA
Title
Mental Development
Description
Mental development was measured using the Bayley Scales of Infant Development.
Time Frame
9 months PMA
Title
Psychomotor Development
Description
Psychomotor Development was measured using the Bayley Scales of Infant Development
Time Frame
9 months PMA
Title
Mental Development
Description
Mental development was measured using the Bayley Scales of Infant Development.
Time Frame
18 months PMA
Title
Psychomotor Development
Description
Psychomotor Development was measured using the Bayley Scales of Infant Development
Time Frame
18 months PMA
Secondary Outcome Measure Information:
Title
Length of Hospitalization in Days
Description
Length of hospitalization from birth until discharge home.
Time Frame
At hospital discharge from 0 to 222 days
Title
Severity of Retinopathy of Prematurity (ROP)
Description
ROP change over time and degree of severity was assessed until 24 months PMA
Time Frame
Up to 52 weeks
Title
visual acuity
Time Frame
Measures at 12 months PMA
Title
Neurological development
Description
Neurological development was assessed by a neurological exam as either normal, suspect or abnormal and the presence of absence of Cerebral Palsy
Time Frame
9 months PMA
Title
Brainstorm Auditory Evoked Potentials
Time Frame
6 months
Title
Neurological development
Description
Neurological development was assessed by a neurological exam as either normal, suspect or abnormal and the presence of absence of Cerebral Palsy
Time Frame
18 months PMA
Title
Change in Retinopathy of Prematurity (ROP)
Description
ROP change over time and degree of severity was assessed until 24 months PMA
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
23 Weeks
Maximum Age & Unit of Time
28 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Debra H Brandon, PhD
Organizational Affiliation
Duke University School of Nursing
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
25932696
Citation
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.
Results Reference
derived
Learn more about this trial
Preterm Infants: Light Effects on Health and Development
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