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Preterm Infants: Light Effects on Health and Development

Preterm Infants: Light Effects on Health and Development

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02146287
Enrollment
121
Registered
2014-05-23
Start date
2003-06-30
Completion date
2008-11-30
Last updated
2017-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Infant Development, Preterm Infant Health

Keywords

cycled light, preterm infants, infant neurodevelopment, infant sleep

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.

Interventions

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).

Sponsors

National Institute of Nursing Research (NINR)
CollaboratorNIH
Duke University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
23 Weeks to 28 Weeks
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Infant weight gain trajectoryweekly inpatient up to 52 weeks post menstral age (PMA) and at outpatient visits to 18 monthsThis measure was single blinded.
Change in sleep development during hospitalizationEvery three weeks up to 52 weeks PMAChange in the developmental pattern of four sleep wake states (active, quiet, transition, awake) were evaluated during hospitalization.
Change in sleep development after discharge homeEvery 5 months following hospital discharge up to 24 months PMAChange in the development of sleep and wake bouts were evaluated following hospital discharge until the infant reached 24 months PMA
Mental Development9 months PMAMental development was measured using the Bayley Scales of Infant Development.
Psychomotor Development9 months PMAPsychomotor Development was measured using the Bayley Scales of Infant Development

Secondary

MeasureTime frameDescription
Length of Hospitalization in DaysAt hospital discharge from 0 to 222 daysLength of hospitalization from birth until discharge home.
Change in Retinopathy of Prematurity (ROP)Every two weeks during hospitalization after 30 weeks PMA up to 52 weeks PMA and during outpatient visits up to 24 months PMAROP change over time and degree of severity was assessed until 24 months PMA
Severity of Retinopathy of Prematurity (ROP)Up to 52 weeksROP change over time and degree of severity was assessed until 24 months PMA
visual acuityMeasures at 12 months PMA
Neurological development9 months PMANeurological development was assessed by a neurological exam as either normal, suspect or abnormal and the presence of absence of Cerebral Palsy
Brainstorm Auditory Evoked Potentials6 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026