Full Enteral NutritionPRETERMNCT06883903
The Effect of Day-Night Cycle on the Transition Time to Full Enteral Feeding in Preterm Newborns Receiving Oropharyngeal Colostrum
A study testing day-night cycle application and routine practice in people with Full Enteral Nutrition and the Day and Night Cycle, run by Biruni University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to examine the effect of the day-night cycle on the transition time to full enteral nutrition in premature infants receiving oropharyngeal colostrum. The study was conducted with a randomized controlled experimental design to test the potential of an environment that supports the biological… Read more about this study
- Who is it for?
- Ages 28 to 32 weeks
- Conditions the study is for
- Full Enteral Nutrition, the Day and Night Cycle
- What is being tested?
- day-night cycle application and routine practice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2022to 22 Dec 2022
- 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 28 to 32 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Those born between 28-32 weeks of gestation.
- Infants of parents who agreed to participate in the study.
- Major congenital anomaly, severe systemic disease, necrotizing enterocolitis presence, presence of suspected or confirmed sepsis, birth asphyxia (cord pH / 29 Newborns without arterial pH <7.0).
- Neonates admitted to the NICU at ≤ 24 hours of age.
Who cannot join
- babies excluded from the inclusion criteria for this study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Biruni Üniversitesi
Istanbul, Zeytinburnu, 34025
About this study
The aim of this study was to examine the effect of the day-night cycle on the transition time to full enteral nutrition in premature infants receiving oropharyngeal colostrum. The study was conducted with a randomized controlled experimental design to test the potential of an environment that supports the biological rhythms of premature infants to improve feeding processes.
The study was conducted on 60 premature infants born at 28-32 weeks of gestation. Infants were randomly assigned to experimental and control groups, and dark-colored covers were used to create a day-night cycle in the experimental group.
Read the detailed description
This study was conducted to determine the effect of day-night cycle on the transition of premature newborns receiving oropharyngeal colostrum to full enteral nutrition. The data of the study, which was conducted in a randomized controlled experimental research design between May and December 2022, were collected in the Neonatology Clinic of a university-affiliated training and research hospital in Istanbul after ethical permissions were obtained. The Neonatology Clinic is a level three Neonatal Intensive Care Unit (NICU) and has the capacity to provide specialized care for premature infants.
Sample selection was done using the randomization software at https://www.randomizer.org. As a result of randomization, 30 babies were included in the experimental group and 30 babies were included in the control group. The sample size was calculated using the G*Power 3.1 program, taking into account the findings of similar studies. As a result of this calculation, at least 28 infants were needed for each group and 30 infants were included in both groups, taking into account case losses. Data were obtained from 60 premature newborns who were hospitalized in the Neonatal Intensive Care Unit at 28-32 weeks of gestation and met the inclusion criteria.
The dependent variables of the study were: time to complete enteral nutrition, physiologic parameters (heart rate, oxygen saturation, respiratory rate), discharge time and discharge weight. The independent variable of the study is the day-night cycle established in the Neonatal Intensive Care Unit.
Inclusion Criteria:
Those born between 28-32 weeks of gestation. Infants of parents who agreed to participate in the study. Major congenital anomaly, severe systemic disease, presence of necrotizing enterocolitis, presence of suspected or confirmed sepsis, birth asphyxia (newborns with cord pH/29 arterial pH <7.0).
Newborns admitted to the NICU at ≤ 24 hours of age.
Exclusion Criteria:
Infants excluded from the inclusion criteria for this study Data Collection Forms In the data collection process, Patient Information Form including demographic and clinical information of premature newborns and Patient Monitoring Charts were used to monitor physiologic parameters during the study. In addition, a Voluntary Consent Form was used to obtain written consent from the parents.
Data Collection Tools
The devices used in the study are as follows:
Philips Intellivue MP50 Bedside Monitor: This device was used to measure heart rate, oxygen saturation and respiratory rate of premature infants.
DragerGiraffe Incubator: These are double-walled, digital weighing incubators used to monitor babies in the NICU. These incubators provide a stable environment by preventing the baby from losing heat.
Smart Sensor AS803 DigitalLuxMeter: It was used to measure the light level in the incubator head. Light level control for the babies in the experimental group was provided with this device.
Incubator Covers: Dark colored (navy blue) covers were used in the experimental group to support the day-night cycle. In the control group, standard white covers were used.
Data Collection The families of the premature infants to be included in the study were informed about the purpose, content and method of the study and their written informed consent was obtained. Newborns in both groups were administered 0.1 ml colostrum into the right and left buccal oral cavity at 3-hour intervals for 14 days. In the experimental group, a 12-hour day-night cycle was established with a white incubator cover during the day and a dark colored incubator cover at night. Physiologic parameters of the infants were recorded with monitors before and after the application. In the experimental group, a day-night cycle was achieved by using dark colored covers for the night, while standard white covers were used in the control group.
- Conditions
- Full Enteral Nutrition, the Day and Night Cycle
- Being tested
- day-night cycle application, routine practice
- Keywords
- Preterm, Oropharyngeal Colostrum, Day-Night Cycle, Full Enteral Nutrition, Circadian Rhythm
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
day-night cycle applicationOther
In this group, colostrum delivered to the unit within the first 5 days of life was administered by the nurse every three hours for 14 days. In order to create a day/night cycle, a white incubator cover was used routinely in the unit during the day (between 08.00-20.00 hours) and a dark colored incubator cover was used at night (between 20.00-08.00 hours).
routine practiceOther
In this group, colostrum delivered to the unit within the first 5 days of life was administered every three hours for 14 days by the nurse.
is the group whose covers are used.
| Study group | Role | What they receive |
|---|---|---|
| day-night cycle application | Experimental | In this group, colostrum delivered to the unit within the first 5 days of life was administered by the nurse every three hours for 14 days. In order to create a day/night cycle, a white incubator cover was used routinely in the unit during the day (between 08.00-20.00 hours) and a dark colored incubator cover was used at night (between 20.00-08.00 hours). Receives: Other: day-night cycle application |
| routine practice | Active comparator | In this group, colostrum delivered to the unit within the first 5 days of life was administered every three hours for 14 days by the nurse.
is the group whose covers are used. Receives: Other: routine practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Light Meter/Photometer
light source in the neonatal intensive care unit and the area illuminated by the source illumination power analyzes between the Smart Sensor AS803 Digital It is done with Lux Meter device. In the NICU, the lowest light level at the beginning of each incubator 10 lux should be configured with a maximum of 600 lux. The light intensity measured in the incubator in the unit varied between 15 and 40 lx.
Measured: 14 days, 08.00 am - 20.00 pm
Secondary outcomes (2)
Patient Information Questionnaire
In the questionnaire prepared to determine the demographic characteristics of premature newborns, questions such as gender, gestational week, mode of delivery, birth weight, hospitalization diagnosis and postnatal age were included. However, it is not a scale.
Measured: baseline
Patient Follow-up questionnaire
It is a form in which respiratory support status, feeding type, type of food taken, IV fluids given, daily fluid intake/ml, transition to full enteral nutrition are recorded in premature newborns, but it is not a scal
Measured: 14 days, 08.00 am - 20.00 pm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start1 May 2022
- Primary completion22 Aug 2022
- Study completion22 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (39)Papers the sponsor has linked to this study.
- Other trials for Full Enteral NutritionStudies of the same condition, open and under way.
- More trials run by Biruni 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In this study, there are two groups, experimental and control. The experimental group was given a white incubator cover with a white floor, which is routinely used in the daytime unit to create a day/night cycle. , dark colored incubator cover was used at night, while the control group received a white incubator with a white floor, which is routinely used in the day/night unit. covers were used.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NEHİR ULU ÖGÜT, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06883903
- Sponsor's protocol ID
- NEHİR ULU ÖĞÜT
- Acronym
- PRETERM
- Status last verified
- Mar 2025
- First submitted
- 24 Feb 2025
- Last updated
- 26 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Als, H. (2009), Newborn individualized developmental care and assessment program (NIDCAP), New frontier for neonatal and perinatal medicine. J Neonat Perinat Med, 135-47.
Altimier., Phillips M.R. (2013), The neonatal ıntegrative developmental care model: seven neuroprotective core measures for family-centered developmental care. Newborn&Infant Nursing Reviews,13, 9-22.
Arslan, F., T., Akkoyun, S. (2019), Yenidoğan bütünleştirici gelişimsel bakım modeli: nöroprotektif aile merkezli gelişimsel bakım için yedi temel ölçüm. Ordu Üniversitesi Hemşirelik Çalışmaları, 2(3), 170-1
Belfort MB, Anderson PJ, Nowak VA, Lee KJ, Molesworth C, Thompson DK, Doyle LW, Inder TE. Breast Milk Feeding, Brain Development, and Neurocognitive Outcomes: A 7-Year Longitudinal Study in Infants Born at Less Than 30 Weeks' Gestation. J Pediatr. 2016 Oct;177:133-139.e1. doi: 10.1016/j.jpeds.2016.06.045. Epub 2016 Jul 29.
PubMed 27480198Bilgen, H., S. (2016), Prematürenin enteral beslenmesi. Klinik Tıp Pediatri Dergisi, 8(2), 45-51.
Callen J, Pinelli J. A review of the literature examining the benefits and challenges, incidence and duration, and barriers to breastfeeding in preterm infants. Adv Neonatal Care. 2005 Apr;5(2):72-88; quiz 89-92. doi: 10.1016/j.adnc.2004.12.003.
PubMed 15806448Cohen S, Mandel D, Mimouni FB, Solovkin L, Dollberg S. Gastric residual in growing preterm infants: effect of body position. Am J Perinatol. 2004 Apr;21(3):163-6. doi: 10.1055/s-2004-823778.
PubMed 15085500Collins CT, Ryan P, Crowther CA, McPhee AJ, Paterson S, Hiller JE. Effect of bottles, cups, and dummies on breast feeding in preterm infants: a randomised controlled trial. BMJ. 2004 Jul 24;329(7459):193-8. doi: 10.1136/bmj.38131.675914.55. Epub 2004 Jun 18.
PubMed 15208209Damato EG. Research into practice. Measuring stress in pre-term infants. AWHONN Lifelines. 2004 Apr-May;8(2):116-8. doi: 10.1177/1091592304265574. No abstract available.
PubMed 15137259Efe, Ö., E., Savaşer, S. (2005), Prematüre bebeklerde yalancı emzik uygulamasının total oral beslenmeye geçiş süresine etkisi. Türkiye Klinikleri, (14): 57- 61.
Escobar C, Rojas-Granados A, Angeles-Castellanos M. Development of the circadian system and relevance of periodic signals for neonatal development. Handb Clin Neurol. 2021;179:249-258. doi: 10.1016/B978-0-12-819975-6.00015-7.
PubMed 34225966Esmaeilizadeh, M., Shoja, M., Shoja, E., Shoja, M., Nejat, H., Oudi, D. (2016), Comparing the effects of continuous and cyclical lightings on weight gain and length of hospital stay among preterm neonates. Mod Care J, 13, e8951
Fucile S, Gisel E, Lau C. Oral stimulation accelerates the transition from tube to oral feeding in preterm infants. J Pediatr. 2002 Aug;141(2):230-6. doi: 10.1067/mpd.2002.125731.
PubMed 12183719Greene Z, O'Donnell CP, Walshe M. Oral stimulation for promoting oral feeding in preterm infants. Cochrane Database Syst Rev. 2016 Sep 20;9(9):CD009720. doi: 10.1002/14651858.CD009720.pub2.
PubMed 27644167Goubet N, Strasbaugh K, Chesney J. Familiarity breeds content? Soothing effect of a familiar odor on full-term newborns. J Dev Behav Pediatr. 2007 Jun;28(3):189-94. doi: 10.1097/dbp.0b013e31802d0b8d.
PubMed 17565285
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Day-Night Cycle on the Transition Time to Full Enteral Feeding in Preterm Newborns Receiving Oropharyngeal Colostrum
- ClinicalTrials.gov ID
- NCT06883903
- Acronym / sponsor ID
- PRETERM / NEHİR ULU ÖĞÜT
- Conditions
- Full Enteral Nutrition, the Day and Night Cycle
- Keywords
- Preterm, Oropharyngeal Colostrum, Day-Night Cycle, Full Enteral Nutrition, Circadian Rhythm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 22 Aug 2022 (actual)
- Study completion
- 22 Dec 2022 (actual)
- First posted
- 19 Mar 2025 (actual)
- 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.
The aim of this study was to examine the effect of the day-night cycle on the transition time to full enteral nutrition in premature infants receiving oropharyngeal colostrum. The study was conducted with a randomized controlled experimental design to test the potential of an environment that supports the biological rhythms of premature infants to improve feeding processes.
The study was conducted on 60 premature infants born at 28-32 weeks of gestation. Infants were randomly assigned to experimental and control groups, and dark-colored covers were used to create a day-night cycle in the experimental group.
Detailed description
This study was conducted to determine the effect of day-night cycle on the transition of premature newborns receiving oropharyngeal colostrum to full enteral nutrition. The data of the study, which was conducted in a randomized controlled experimental research design between May and December 2022, were collected in the Neonatology Clinic of a university-affiliated training and research hospital in Istanbul after ethical permissions were obtained. The Neonatology Clinic is a level three Neonatal Intensive Care Unit (NICU) and has the capacity to provide specialized care for premature infants.
Sample selection was done using the randomization software at https://www.randomizer.org. As a result of randomization, 30 babies were included in the experimental group and 30 babies were included in the control group. The sample size was calculated using the G*Power 3.1 program, taking into account the findings of similar studies. As a result of this calculation, at least 28 infants were needed for each group and 30 infants were included in both groups, taking into account case losses. Data were obtained from 60 premature newborns who were hospitalized in the Neonatal Intensive Care Unit at 28-32 weeks of gestation and met the inclusion criteria.
The dependent variables of the study were: time to complete enteral nutrition, physiologic parameters (heart rate, oxygen saturation, respiratory rate), discharge time and discharge weight. The independent variable of the study is the day-night cycle established in the Neonatal Intensive Care Unit.
Inclusion Criteria:
Those born between 28-32 weeks of gestation. Infants of parents who agreed to participate in the study. Major congenital anomaly, severe systemic disease, presence of necrotizing enterocolitis, presence of suspected or confirmed sepsis, birth asphyxia (newborns with cord pH/29 arterial pH <7.0).
Newborns admitted to the NICU at ≤ 24 hours of age.
Exclusion Criteria:
Infants excluded from the inclusion criteria for this study Data Collection Forms In the data collection process, Patient Information Form including demographic and clinical information of premature newborns and Patient Monitoring Charts were used to monitor physiologic parameters during the study. In addition, a Voluntary Consent Form was used to obtain written consent from the parents.
Data Collection Tools
The devices used in the study are as follows:
Philips Intellivue MP50 Bedside Monitor: This device was used to measure heart rate, oxygen saturation and respiratory rate of premature infants.
DragerGiraffe Incubator: These are double-walled, digital weighing incubators used to monitor babies in the NICU. These incubators provide a stable environment by preventing the baby from losing heat.
Smart Sensor AS803 DigitalLuxMeter: It was used to measure the light level in the incubator head. Light level control for the babies in the experimental group was provided with this device.
Incubator Covers: Dark colored (navy blue) covers were used in the experimental group to support the day-night cycle. In the control group, standard white covers were used.
Data Collection The families of the premature infants to be included in the study were informed about the purpose, content and method of the study and their written informed consent was obtained. Newborns in both groups were administered 0.1 ml colostrum into the right and left buccal oral cavity at 3-hour intervals for 14 days. In the experimental group, a 12-hour day-night cycle was established with a white incubator cover during the day and a dark colored incubator cover at night. Physiologic parameters of the infants were recorded with monitors before and after the application. In the experimental group, a day-night cycle was achieved by using dark colored covers for the night, while standard white covers were used in the control group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In this study, there are two groups, experimental and control. The experimental group was given a white incubator cover with a white floor, which is routinely used in the daytime unit to create a day/night cycle. , dark colored incubator cover was used at night, while the control group received a white incubator with a white floor, which is routinely used in the day/night unit. covers were used.
| Arm | Type | Receives |
|---|---|---|
| day-night cycle application | Experimental | Other: day-night cycle applicationIn this group, colostrum delivered to the unit within the first 5 days of life was administered by the nurse every three hours for 14 days. In order to create a day/night cycle, a white incubator cover was used routinely in the unit during the day (between 08.00-20.00 hours) and a dark colored incubator cover was used at night (between 20.00-08.00 hours). |
| routine practice | Active comparator | Other: routine practiceIn this group, colostrum delivered to the unit within the first 5 days of life was administered every three hours for 14 days by the nurse. is the group whose covers are used. |
Who may qualify
- Ages
- 28 to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Those born between 28-32 weeks of gestation.
- Infants of parents who agreed to participate in the study.
- Major congenital anomaly, severe systemic disease, necrotizing enterocolitis presence, presence of suspected or confirmed sepsis, birth asphyxia (cord pH / 29 Newborns without arterial pH <7.0).
- Neonates admitted to the NICU at ≤ 24 hours of age.
Key exclusion criteria (1 listed)
- babies excluded from the inclusion criteria for this study
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 |
|---|---|---|
| day-night cycle applicationIn this group, colostrum delivered to the unit within the first 5 days of life was administered by the nurse every three hours for 14 days. In order to create a day/night cycle, a white incubator cover was used routinely in the unit during the day (between 08.00-20.00 hours) and a dark colored incubator cover was used at night (between 20.00-08.00 hours). | Other | day-night cycle application |
| routine practiceIn this group, colostrum delivered to the unit within the first 5 days of life was administered every three hours for 14 days by the nurse. is the group whose covers are used. | Other | routine practice |
Primary outcome
Light Meter/Photometer
Time frame: 14 days, 08.00 am - 20.00 pm
light source in the neonatal intensive care unit and the area illuminated by the source illumination power analyzes between the Smart Sensor AS803 Digital It is done with Lux Meter device. In the NICU, the lowest light level at the beginning of each incubator 10 lux should be configured with a maximum of 600 lux. The light intensity measured in the incubator in the unit varied between 15 and 40 lx.
2 secondary outcomes
Patient Information Questionnaire
Time frame: baseline
Patient Follow-up questionnaire
Time frame: 14 days, 08.00 am - 20.00 pm
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 26 Mar 2025.
- BackgroundAls, H. (2009), Newborn individualized developmental care and assessment program (NIDCAP), New frontier for neonatal and perinatal medicine. J Neonat Perinat Med, 135-47.
- BackgroundAltimier., Phillips M.R. (2013), The neonatal ıntegrative developmental care model: seven neuroprotective core measures for family-centered developmental care. Newborn&Infant Nursing Reviews,13, 9-22.
- BackgroundArslan, F., T., Akkoyun, S. (2019), Yenidoğan bütünleştirici gelişimsel bakım modeli: nöroprotektif aile merkezli gelişimsel bakım için yedi temel ölçüm. Ordu Üniversitesi Hemşirelik Çalışmaları, 2(3), 170-1
- Background: PubMed 27480198Belfort MB, Anderson PJ, Nowak VA, Lee KJ, Molesworth C, Thompson DK, Doyle LW, Inder TE. Breast Milk Feeding, Brain Development, and Neurocognitive Outcomes: A 7-Year Longitudinal Study in Infants Born at Less Than 30 Weeks' Gestation. J Pediatr. 2016 Oct;177:133-139.e1. doi: 10.1016/j.jpeds.2016.06.045. Epub 2016 Jul 29.
- BackgroundBilgen, H., S. (2016), Prematürenin enteral beslenmesi. Klinik Tıp Pediatri Dergisi, 8(2), 45-51.
- Background: PubMed 15806448Callen J, Pinelli J. A review of the literature examining the benefits and challenges, incidence and duration, and barriers to breastfeeding in preterm infants. Adv Neonatal Care. 2005 Apr;5(2):72-88; quiz 89-92. doi: 10.1016/j.adnc.2004.12.003.
- Background: PubMed 15085500Cohen S, Mandel D, Mimouni FB, Solovkin L, Dollberg S. Gastric residual in growing preterm infants: effect of body position. Am J Perinatol. 2004 Apr;21(3):163-6. doi: 10.1055/s-2004-823778.
- Background: PubMed 15208209Collins CT, Ryan P, Crowther CA, McPhee AJ, Paterson S, Hiller JE. Effect of bottles, cups, and dummies on breast feeding in preterm infants: a randomised controlled trial. BMJ. 2004 Jul 24;329(7459):193-8. doi: 10.1136/bmj.38131.675914.55. Epub 2004 Jun 18.
- Background: PubMed 15137259Damato EG. Research into practice. Measuring stress in pre-term infants. AWHONN Lifelines. 2004 Apr-May;8(2):116-8. doi: 10.1177/1091592304265574. No abstract available.
- BackgroundEfe, Ö., E., Savaşer, S. (2005), Prematüre bebeklerde yalancı emzik uygulamasının total oral beslenmeye geçiş süresine etkisi. Türkiye Klinikleri, (14): 57- 61.
- Background: PubMed 34225966Escobar C, Rojas-Granados A, Angeles-Castellanos M. Development of the circadian system and relevance of periodic signals for neonatal development. Handb Clin Neurol. 2021;179:249-258. doi: 10.1016/B978-0-12-819975-6.00015-7.
- BackgroundEsmaeilizadeh, M., Shoja, M., Shoja, E., Shoja, M., Nejat, H., Oudi, D. (2016), Comparing the effects of continuous and cyclical lightings on weight gain and length of hospital stay among preterm neonates. Mod Care J, 13, e8951
- Individual participant dataSharing planned: No
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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?
A study testing day-night cycle application and routine practice in people with Full Enteral Nutrition and the Day and Night Cycle, run by Biruni University 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 4 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 26 Mar 2025. 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?
Light Meter/Photometer (time frame: 14 days, 08.00 am - 20.00 pm). 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 NCT06883903, which also lists 39 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 26 Mar 2025.