Preterm Infants: Light Effects on Health and Development

Study Overview
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Brief Summary
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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.

Official Title
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Preterm Infants: Light Effects on Health and Development

Conditions
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Preterm Infant Health, Preterm Infant Development

Intervention / Treatment
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* Other: Cycled Light


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 23 Weeks
Maximum Age: 28 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Early Cycled Light<br>Infants received day night cycling of light on a 12-hour on and 12-hour off basis beginning at 28 weeks PMA | Other: Cycled Light<br>* 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).<br>|
| Active Comparator: Late Cycled Light<br>Infants received day night cycling of light on a 12-hour on and 12-hour off basis beginning at 36 weeks PMA | Other: Cycled Light<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant weight gain trajectory | 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 | 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 | 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 | Mental development was measured using the Bayley Scales of Infant Development. | 9 months PMA | 
| Psychomotor Development | Psychomotor Development was measured using the Bayley Scales of Infant Development | 9 months PMA | 
| Mental Development | Mental development was measured using the Bayley Scales of Infant Development. | 18 months PMA | 
| Psychomotor Development | 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 | Length of hospitalization from birth until discharge home. | At hospital discharge from 0 to 222 days | 
| Severity of Retinopathy of Prematurity (ROP) | ROP change over time and degree of severity was assessed until 24 months PMA | Up to 52 weeks | 
| visual acuity |  | Measures at 12 months PMA | 
| Neurological development | 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 |  | 6 months | 
| Neurological development | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cycled light, preterm infants, infant neurodevelopment, infant sleep