Preterm Infants: Light Effects on Health and Development

Preterm Infant Development Clinical Trial

Official title:

Preterm Infants: Light Effects on Health and Development

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02146287
• Other study ID #: Pro00011520
• Secondary ID: R01NR008044
• Status: Completed
• Phase: N/A
• First received: May 21, 2014
• Last updated: March 27, 2017
• Start date: June 2003
• Est. completion date: November 2008

Study information

• Verified date: March 2017
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 23 Weeks to 28 Weeks

Eligibility

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)

Related Conditions & MeSH terms

• Premature Birth
• Preterm Infant Development
• Preterm Infant Health

Intervention

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).

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Institute of Nursing Research (NINR)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Mental Development	Mental development was measured using the Bayley Scales of Infant Development.	9 months PMA
Primary	Psychomotor Development	Psychomotor Development was measured using the Bayley Scales of Infant Development	9 months PMA
Primary	Mental Development	Mental development was measured using the Bayley Scales of Infant Development.	18 months PMA
Primary	Psychomotor Development	Psychomotor Development was measured using the Bayley Scales of Infant Development	18 months PMA
Secondary	Length of Hospitalization in Days	Length of hospitalization from birth until discharge home.	At hospital discharge from 0 to 222 days
Secondary	Severity of Retinopathy of Prematurity (ROP)	ROP change over time and degree of severity was assessed until 24 months PMA	Up to 52 weeks
Secondary	visual acuity		Measures at 12 months PMA
Secondary	Neurological development	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
Secondary	Brainstorm Auditory Evoked Potentials		6 months
Secondary	Neurological development	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
Secondary	Change in Retinopathy of Prematurity (ROP)	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