Preterm Infants: Light Effects on Health and Development

March 27, 2017 updated by: Duke University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

121

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months to 6 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
weekly inpatient up to 52 weeks post menstral age (PMA) and at outpatient visits to 18 months
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.
Every three weeks up to 52 weeks PMA
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
Every 5 months following hospital discharge up to 24 months PMA
Mental Development
Time Frame: 9 months PMA
Mental development was measured using the Bayley Scales of Infant Development.
9 months PMA
Psychomotor Development
Time Frame: 9 months PMA
Psychomotor Development was measured using the Bayley Scales of Infant Development
9 months PMA
Mental Development
Time Frame: 18 months PMA
Mental development was measured using the Bayley Scales of Infant Development.
18 months PMA
Psychomotor Development
Time Frame: 18 months PMA
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
Time Frame: At hospital discharge from 0 to 222 days
Length of hospitalization from birth until discharge home.
At hospital discharge from 0 to 222 days
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
Up to 52 weeks
visual acuity
Time Frame: Measures at 12 months PMA
Measures at 12 months PMA
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
9 months PMA
Brainstorm Auditory Evoked Potentials
Time Frame: 6 months
6 months
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
18 months PMA
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
Every two weeks during hospitalization after 30 weeks PMA up to 52 weeks PMA and during outpatient visits up to 24 months PMA

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

National Institute of Nursing Research (NINR)

Investigators

  • Principal Investigator: Debra H Brandon, PhD, Duke University School of Nursing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

May 21, 2014

First Submitted That Met QC Criteria

May 21, 2014

First Posted (Estimate)

May 23, 2014

Study Record Updates

Last Update Posted (Actual)

March 29, 2017

Last Update Submitted That Met QC Criteria

March 27, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00011520
  • R01NR008044 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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