Preterm Infant HealthNCT02146287
Preterm Infants: Light Effects on Health and Development
A study testing Cycled Light in people with Preterm Infant Health and Preterm Infant Development, run by Duke University.
Trial 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. Read more about this study
- Who is it for?
- Ages 23 to 28 weeks
- Conditions the study is for
- Preterm Infant Health, Preterm Infant Development
- What is being tested?
- Cycled Light
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- No sites listed yet
- Study dates
- Jun 2003to Nov 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 28 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants were < 7 days of age and were born at 28 weeks or < 28 weeks
Who cannot join
- known anomalies associated with neurological or visual problems (e.g., congenital glaucoma, Down Syndrome)
About this study
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.
- Conditions
- Preterm Infant Health, Preterm Infant Development
- Being tested
- Cycled Light
- Keywords
- cycled light, preterm infants, infant neurodevelopment, infant sleep
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Cycled Light |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant weight gain trajectory
This measure was single blinded.
Measured: 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.
Measured: 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
Measured: Every 5 months following hospital discharge up to 24 months PMA
Mental Development
Mental development was measured using the Bayley Scales of Infant Development.
Measured: 9 months PMA
Psychomotor Development
Psychomotor Development was measured using the Bayley Scales of Infant Development
Measured: 9 months PMA
Mental Development
Mental development was measured using the Bayley Scales of Infant Development.
Measured: 18 months PMA
Psychomotor Development
Psychomotor Development was measured using the Bayley Scales of Infant Development
Measured: 18 months PMA
Secondary outcomes (7)
Length of Hospitalization in Days
Length of hospitalization from birth until discharge home.
Measured: At hospital discharge from 0 to 222 days
Severity of Retinopathy of Prematurity (ROP)
ROP change over time and degree of severity was assessed until 24 months PMA
Measured: Up to 52 weeks
visual acuity
Measured: Measures at 12 months PMA
Neurological development
Neurological development was assessed by a neurological exam as either normal, suspect or abnormal and the presence of absence of Cerebral Palsy
Measured: 9 months PMA
Brainstorm Auditory Evoked Potentials
Measured: 6 months
Neurological development
Neurological development was assessed by a neurological exam as either normal, suspect or abnormal and the presence of absence of Cerebral Palsy
Measured: 18 months PMA
Change in Retinopathy of Prematurity (ROP)
ROP change over time and degree of severity was assessed until 24 months PMA
Measured: Every two weeks during hospitalization after 30 weeks PMA up to 52 weeks PMA and during outpatient visits up to 24 months PMA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2014 (estimated)
- Study startJun 2003
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Preterm Infant HealthStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Debra H Brandon, PhD, Principal investigator, Duke University School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02146287
- Sponsor's protocol ID
- Pro00011520
- Other IDs
- R01NR008044
- Status last verified
- Mar 2017
- First submitted
- 21 May 2014
- Last updated
- 29 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 39699174Park 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.
PubMed 25932696
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preterm Infants: Light Effects on Health and Development
- ClinicalTrials.gov ID
- NCT02146287
- Acronym / sponsor ID
- Pro00011520
- Conditions
- Preterm Infant Health, Preterm Infant Development
- Keywords
- cycled light, preterm infants, infant neurodevelopment, infant sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Jun 2003
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 23 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Cycled Light | Active comparator | Other: Cycled LightInfants received day night cycling of light on a 12-hour on and 12-hour off basis beginning at 28 weeks PMA |
| Late Cycled Light | Active comparator | Other: Cycled LightInfants received day night cycling of light on a 12-hour on and 12-hour off basis beginning at 36 weeks PMA |
Who may qualify
- Ages
- 23 to 28 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Infants were < 7 days of age and were born at 28 weeks or < 28 weeks
Key exclusion criteria (1 listed)
- known anomalies associated with neurological or visual problems (e.g., congenital glaucoma, Down Syndrome)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cycled LightCycled 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). | Other | Early Cycled Light, Late Cycled Light |
Primary outcome
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.
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.
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
Mental Development
Time frame: 9 months PMA
Mental development was measured using the Bayley Scales of Infant Development.
Psychomotor Development
Time frame: 9 months PMA
Psychomotor Development was measured using the Bayley Scales of Infant Development
Mental Development
Time frame: 18 months PMA
Mental development was measured using the Bayley Scales of Infant Development.
Psychomotor Development
Time frame: 18 months PMA
Psychomotor Development was measured using the Bayley Scales of Infant Development
7 secondary outcomes
Length of Hospitalization in Days
Time frame: At hospital discharge from 0 to 222 days
Severity of Retinopathy of Prematurity (ROP)
Time frame: Up to 52 weeks
visual acuity
Time frame: Measures at 12 months PMA
Neurological development
Time frame: 9 months PMA
Brainstorm Auditory Evoked Potentials
Time frame: 6 months
Neurological development
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2017.
- Derived from this study: PubMed 39699174Morag 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.
- Derived from this study: PubMed 25932696Park 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.
Related trials for Preterm Infant Health
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Prematurity
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Postpartum Complication, Postpartum
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Personalized Care for Prenatal Stress Reduction & Prevention of Preterm Birth (PTB) Disparities
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High-energy Human Milk Diets in the First Two Weeks After Birth to Reduce BPD in Extremely Preterm Infants
Extreme Prematurity, Enteral Nutrition
Active, not recruitingObservational study
Analysis on the Health of Newborns in Three Hospitals, 2008-2024
Neonatal Morbidity and Mortality, Intrauterine Growth Disorders (IUGR and Macrosomia)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Debra H Brandon, PhD principal investigator
Duke University School of Nursing
Questions about this trial
What is this clinical trial studying?
A study testing Cycled Light in people with Preterm Infant Health and Preterm Infant Development, run by Duke University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infant weight gain trajectory (time frame: weekly inpatient up to 52 weeks post menstral age (PMA) and at outpatient visits to 18 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02146287, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2017.