NCT02088359

Brief Summary

Infants are exposed to either continuous bright light continuous near darkness or unstructured combination of the two. The investigators primary objective is to determine the effectiveness cycled light and near darkness on growth in preterm infants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

1 active site

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, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 14, 2014

Completed
Last Updated

July 8, 2014

Status Verified

June 1, 2012

Enrollment Period

7 months

First QC Date

March 7, 2014

Last Update Submit

July 7, 2014

Conditions

Compare of Effectiveness Cycled Light and Near Darkness on Growth in Preterm Infants

Keywords

cycled light, near darkness, growth

Outcome Measures

Primary Outcomes (1)

  • Effectiveness on growth

    We recorded infants' weight, height and head circumference measures on day 14, corrected 3 and 6 months.

    3-12 months

Secondary Outcomes (2)

  • Feeding

    0-1 month

  • Ventilation support

    0-1 month

Study Arms (2)

Cycled light

Approximately 12 hours of light on and 12 hours of light off.

Other: Cycled light

Near darkness

Continue near darkness

Other: Continue near darkness

Interventions

Cycled lightOTHER

We covered the incubator with blanket for darkness approximately 12 hours.

Cycled light
Continue near darknessOTHER

We covered the incubator with blanket all days.

Near darkness

Eligibility Criteria

AgeUp to 24 Hours
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Preterm infant (\<32 gestational weeks) were enrolled in this study.

You may qualify if:

  • \<32 gestational weeks preterm infants

You may not qualify if:

  • Major congenital anomaly
  • Small for gestation age
  • Grade III-IV intracranial hemorrhage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zekai Tahir Burak Maternity Teaching Hospital

Ankara, 06230, Turkey (Türkiye)

Location

Related Publications (1)

  • 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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Zekai Tahir Burak Maternity and Teaching Hospital

Study Record Dates

First Submitted

March 7, 2014

First Posted

March 14, 2014

Study Start

June 1, 2012

Primary Completion

January 1, 2013

Study Completion

January 1, 2014

Last Updated

July 8, 2014

Record last verified: 2012-06

Locations

TU(1)