search
Back to results

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
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

23 Weeks - 28 Weeks (Child)All SexesDoes not accept healthy volunteers

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

    First Posted
    May 21, 2014
    Last Updated
    March 27, 2017
    Sponsor
    Duke University
    Collaborators
    National Institute of Nursing Research (NINR)
    search

    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

    We'll reach out to this number within 24 hrs