NCT02146287

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
121

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2003

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

May 21, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 23, 2014

Completed
Last Updated

March 29, 2017

Status Verified

March 1, 2017

Enrollment Period

5.4 years

First QC Date

May 21, 2014

Last Update Submit

March 27, 2017

Conditions

Preterm Infant HealthPreterm Infant Development

Keywords

cycled lightpreterm infantsinfant neurodevelopmentinfant sleep

Outcome Measures

Primary Outcomes (7)

  • 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 Outcomes (7)

  • Length of Hospitalization in Days

    At hospital discharge from 0 to 222 days

  • Severity of Retinopathy of Prematurity (ROP)

    Up to 52 weeks

  • visual acuity

    Measures at 12 months PMA

  • Neurological development

    9 months PMA

  • Brainstorm Auditory Evoked Potentials

    6 months

  • +2 more secondary outcomes

Study Arms (2)

Early Cycled Light

ACTIVE COMPARATOR

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

Late Cycled Light

ACTIVE COMPARATOR

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

Interventions

Cycled LightOTHER

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).

Early Cycled LightLate Cycled Light

Eligibility Criteria

Age23 Weeks - 28 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Infants were \< 7 days of age and were born at 28 weeks or \< 28 weeks

You may not qualify if:

  • known anomalies associated with neurological or visual problems (e.g., congenital glaucoma, Down Syndrome)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Morag I, Xiao YT, Bruschettini M. Cycled light in the intensive care unit for preterm and low birth weight infants. Cochrane Database Syst Rev. 2024 Dec 19;12(12):CD006982. doi: 10.1002/14651858.CD006982.pub5.

    PMID: 39699174DERIVED

  • 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.

    PMID: 25932696DERIVED

Study Officials

  • Debra H Brandon, PhD

    Duke University School of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2014

First Posted

May 23, 2014

Study Start

June 1, 2003

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

March 29, 2017

Record last verified: 2017-03