Compare of Effectiveness Cycled Light and Near Darkness on Growth in Preterm InfantsNCT02088359
Compare of Effectiveness Cycled Light or Near Darkness on Growth Parameters in Preterm Infants
An observational study of Compare of Effectiveness Cycled Light and Near Darkness on Growth in Preterm Infants, run by Zekai Tahir Burak Women's Health Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 24 hoursHealthy volunteers can take part
- Conditions the study is for
- Compare of Effectiveness Cycled Light and Near Darkness on Growth in Preterm Infants
- What is being tested?
- Cycled light and Continue near darkness
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jun 2012to Jan 2014
- Phase
- Observational
- 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 Up to 24 hours
- All sexes
- Healthy volunteers accepted
- Child
Study population: Preterm infant (<32 gestational weeks) were enrolled in this study.
Who may be able to join
- <32 gestational weeks preterm infants
Who cannot join
- Major congenital anomaly
- Small for gestation age
- Grade III-IV intracranial hemorrhage
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zekai Tahir Burak Maternity Teaching Hospital
Ankara, 06230
About this study
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.
- Being tested
- Cycled light, Continue near darkness
- Keywords
- cycled light, near darkness, growth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cycled lightOther
We covered the incubator with blanket for darkness approximately 12 hours.
Continue near darknessOther
We covered the incubator with blanket all days.
| Study group | Role | What they receive |
|---|---|---|
| Cycled light | Approximately 12 hours of light on and 12 hours of light off. Receives: Other: Cycled light | |
| Near darkness | Continue near darkness Receives: Other: Continue near darkness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness on growth
We recorded infants' weight, height and head circumference measures on day 14, corrected 3 and 6 months.
Measured: 3-12 months
Secondary outcomes (2)
Feeding
We evaluated full enteral feeding time between two groups.
Measured: 0-1 month
Ventilation support
We evaluated duration of supplemental oxygen, nasal continuous positive airway pressure (CPAP) and mechanical ventilation for each groups.
Measured: 0-1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2014 (estimated)
- Study startJun 2012
- Primary completionJan 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Compare of Effectiveness Cycled Light and Near Darkness on Growth in Preterm InfantsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Yekta, Zekai Tahir Burak Women's Health Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02088359
- Sponsor's protocol ID
- ZTB000123
- Status last verified
- Jun 2012
- First submitted
- 7 Mar 2014
- Last updated
- 8 Jul 2014
- Results posted
- No
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 39699174
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compare of Effectiveness Cycled Light or Near Darkness on Growth Parameters in Preterm Infants
- ClinicalTrials.gov ID
- NCT02088359
- Acronym / sponsor ID
- ZTB000123
- Keywords
- cycled light, near darkness, growth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education HospitalUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 14 Mar 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cycled light | – | Other: Cycled lightApproximately 12 hours of light on and 12 hours of light off. |
| Near darkness | – | Other: Continue near darknessContinue near darkness |
Who may qualify
- Ages
- Up to 24 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Preterm infant (<32 gestational weeks) were enrolled in this study.
Key inclusion criteria (1 listed)
- <32 gestational weeks preterm infants
Key exclusion criteria (3 listed)
- Major congenital anomaly
- Small for gestation age
- Grade III-IV intracranial hemorrhage
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 lightWe covered the incubator with blanket for darkness approximately 12 hours. | Other | Cycled light |
| Continue near darknessWe covered the incubator with blanket all days. | Other | Near darkness |
Primary outcome
Effectiveness on growth
Time frame: 3-12 months
We recorded infants' weight, height and head circumference measures on day 14, corrected 3 and 6 months.
2 secondary outcomes
Feeding
Time frame: 0-1 month
Ventilation support
Time frame: 0-1 month
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 8 Jul 2014.
- 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.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Compare of Effectiveness Cycled Light and Near Darkness on Growth in Preterm Infants, run by Zekai Tahir Burak Women's Health Research and Education Hospital at 1 site in Turkey (Türkiye).
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 3 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 8 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Effectiveness on growth (time frame: 3-12 months). 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 NCT02088359, which also lists 1 linked publication.
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 8 Jul 2014.