Preterm Infants: Light Effects on Health and Development

Not Applicable

Completed

• Conditions: Preterm Infant Development; Preterm Infant Health
• Interventions: Other: Cycled Light

• Registration Number: NCT02146287
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-06
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Study First Submitted: 2014-05-21
• Study First Submitted QC: 2014-05-21
• Study First Posted: 2014-05-23
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-27
• Last Update Posted: 2017-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early Cycled Light	Cycled Light	Infants received day night cycling of light on a 12-hour on and 12-hour off basis beginning at 28 weeks PMA
Late Cycled Light	Cycled Light	Infants received day night cycling of light on a 12-hour on and 12-hour off basis beginning at 36 weeks PMA

Primary Outcome Measures

Name	Time	Method
Change in sleep development after discharge home	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	18 months PMA	Mental development was measured using the Bayley Scales of Infant Development.
Psychomotor Development	18 months PMA	Psychomotor Development was measured using the Bayley Scales of Infant Development
Infant weight gain trajectory	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	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.

Secondary Outcome Measures

Name	Time	Method
Neurological development	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
Length of Hospitalization in Days	At hospital discharge from 0 to 222 days	Length of hospitalization from birth until discharge home.
Severity of Retinopathy of Prematurity (ROP)	Up to 52 weeks	ROP change over time and degree of severity was assessed until 24 months PMA
visual acuity	Measures at 12 months PMA
Brainstorm Auditory Evoked Potentials	6 months
Change in Retinopathy of Prematurity (ROP)	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