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Completed

NCT Number: NCT02146287

Preterm Infants: Light Effects on Health and Development

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.

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Key information

Conditions

Preterm Infant Health Preterm Infant Development

Age range

23 week–28 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Cycled Light

Other

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Important dates

Study start
2003
Primary completion
2008
Study completion
2008
First posted
May 23, 2014
Registry last updated
Mar 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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