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Preterm Infants: Light Effects on Health and Development

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ClinicalTrials.gov Identifier: NCT02146287
Recruitment Status : Completed
First Posted : May 23, 2014
Last Update Posted : March 29, 2017
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Duke University

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.

Condition or disease Intervention/treatment Phase
Preterm Infant Health Preterm Infant Development Other: Cycled Light Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Preterm Infants: Light Effects on Health and Development
Study Start Date : June 2003
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

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
Other: 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).


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
Other: 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).





Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. Mental Development [ Time Frame: 9 months PMA ]
    Mental development was measured using the Bayley Scales of Infant Development.

  5. Psychomotor Development [ Time Frame: 9 months PMA ]
    Psychomotor Development was measured using the Bayley Scales of Infant Development

  6. Mental Development [ Time Frame: 18 months PMA ]
    Mental development was measured using the Bayley Scales of Infant Development.

  7. Psychomotor Development [ Time Frame: 18 months PMA ]
    Psychomotor Development was measured using the Bayley Scales of Infant Development


Secondary Outcome Measures :
  1. Length of Hospitalization in Days [ Time Frame: At hospital discharge from 0 to 222 days ]
    Length of hospitalization from birth until discharge home.

  2. 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

  3. visual acuity [ Time Frame: Measures at 12 months PMA ]
  4. 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

  5. Brainstorm Auditory Evoked Potentials [ Time Frame: 6 months ]
  6. 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

  7. 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



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Ages Eligible for Study:   23 Weeks to 28 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02146287


Sponsors and Collaborators
Duke University
National Institute of Nursing Research (NINR)
Investigators
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Principal Investigator: Debra H Brandon, PhD Duke University School of Nursing

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02146287     History of Changes
Other Study ID Numbers: Pro00011520
R01NR008044 ( U.S. NIH Grant/Contract )
First Posted: May 23, 2014    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: March 2017

Keywords provided by Duke University:
cycled light
preterm infants
infant neurodevelopment
infant sleep

Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications