Nutrition, HealthyNCT05849948
Effect Of Chronobıologıcal Nutrıtıon On Premature Babıes
A study testing choronobiological nutrition in people with Nutrition, Healthy, run by Eskisehir Osmangazi University.
Trial summary
The aim of this study is to determine the effect of chronobiological nutrition approach on the growth and breastfeeding processes of premature babies. It will be carried out in a randomized controlled experimental design. In the study, it is planned to have 2 groups as experimental and control. Read more about this study
- Who is it for?
- Ages 30 to 36 weeksHealthy volunteers can take part
- Conditions the study is for
- Nutrition, Healthy
- What is being tested?
- choronobiological nutrition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2023to 1 Jun 2024
- 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 30 to 36 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Being treated in the NICU
- Gestation week is between 30 and 36
- The delivery took place in the hospital where the study was conducted.
- 70% of the daily enteral feeding is done with breast milk
Who cannot join
- The baby is less than 30 weeks of gestation and greater than 36 weeks of gestation.
- Having neurological sequelae
- Having Grade 4 intraventricular bleeding
- The development of problems such as sepsis, NEC, which may change the general condition
- Being followed in invasive mechanical ventilation
- Receiving narcotic analgesics and sedation
- The baby has been shipped from outside
- Having undergone gastrointestinal (GIS) surgery or having GIS anomaly
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Chronobiological Nutritional Approach on Growth and Breastfeeding Processes of Premature Babies
The aim of this study is to determine the effect of chronobiological nutrition approach on the growth and breastfeeding processes of premature babies. It will be carried out in a randomized controlled experimental design. In the study, it is planned to have 2 groups as experimental and control. As a result of the power analysis using the G Power 3.0.10 program, 90% power; A total of at least 78 samples were found to be sufficient in the study with a 5% margin of error (n1: 39; n2: 39). However, considering that the case could be lost, it was decided to increase it by 20% to 94 babies. Infants will be assigned to groups using a stratified sequential block randomization method. Premature babies will be stratified by week of gestation, birth weight and sex, and then an equal number of babies will be assigned to each group by blocking.
The appointment of premature infants will be decided by sequential block randomization.
After the descriptive information of the babies assigned to the groups is recorded in the questionnaire, the experimental group will be fed by applying the chronobiological nutrition approach. The control group will be fed without applying the chronobiological nutrition approach. The discharge times will be calculated for both groups.
- Conditions
- Nutrition, Healthy
- Being tested
- choronobiological nutrition
- Keywords
- premature, chorobiological nutrition, Breastfeeding Processes
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
choronobiological nutritionBehavioural
Providing infant nutrition in accordance with crinobiological nutrition
| Study group | Role | What they receive |
|---|---|---|
| choronobiological nutrition group | Experimental | newborns were fed according to chronobiological nutrition Receives: Behavioral: choronobiological nutrition |
| control group | No intervention | newborns will be fed in the order in which breastmilk is delivered to the hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in the discharge time of newborns will be evaluated by using a questionnaire prepared by the researcher.
newborn was evaluated during hospital treatment
Measured: The newborn will be evaluated once a week for up to an average of 6 weeks after the date of hospitalization.
Secondary outcomes (1)
Weight gain of newborns will be evaluated using a questionnaire prepared by the investigator.
newborn was evaluated during hospital treatment
Measured: The newborn will be evaluated once a week for up to an average of 6 weeks after the date of hospitalization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start1 Jun 2023 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition, HealthyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ezgi Ayvaz, Eskisehir Osmangazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05849948
- Sponsor's protocol ID
- YENİDOĞAN DOKTORA TEZ
- Status last verified
- Apr 2023
- First submitted
- 18 Apr 2023
- Last updated
- 9 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Chronobiological Nutritional Approach on Growth and Breastfeeding Processes of Premature Babies
- ClinicalTrials.gov ID
- NCT05849948
- Acronym / sponsor ID
- YENİDOĞAN DOKTORA TEZ
- Conditions
- Nutrition, Healthy
- Keywords
- premature, chorobiological nutrition, Breastfeeding Processes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 9 May 2023 (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 is to determine the effect of chronobiological nutrition approach on the growth and breastfeeding processes of premature babies. It will be carried out in a randomized controlled experimental design. In the study, it is planned to have 2 groups as experimental and control. As a result of the power analysis using the G Power 3.0.10 program, 90% power; A total of at least 78 samples were found to be sufficient in the study with a 5% margin of error (n1: 39; n2: 39). However, considering that the case could be lost, it was decided to increase it by 20% to 94 babies. Infants will be assigned to groups using a stratified sequential block randomization method. Premature babies will be stratified by week of gestation, birth weight and sex, and then an equal number of babies will be assigned to each group by blocking.
The appointment of premature infants will be decided by sequential block randomization.
After the descriptive information of the babies assigned to the groups is recorded in the questionnaire, the experimental group will be fed by applying the chronobiological nutrition approach. The control group will be fed without applying the chronobiological nutrition approach. The discharge times will be calculated for both groups.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| choronobiological nutrition group | Experimental | Behavioral: choronobiological nutritionnewborns were fed according to chronobiological nutrition |
| control group | No intervention | –newborns will be fed in the order in which breastmilk is delivered to the hospital |
Who may qualify
- Ages
- 30 to 36 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Being treated in the NICU
- Gestation week is between 30 and 36
- The delivery took place in the hospital where the study was conducted.
- 70% of the daily enteral feeding is done with breast milk
Key exclusion criteria (8 listed)
- The baby is less than 30 weeks of gestation and greater than 36 weeks of gestation.
- Having neurological sequelae
- Having Grade 4 intraventricular bleeding
- The development of problems such as sepsis, NEC, which may change the general condition
- Being followed in invasive mechanical ventilation
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 |
|---|---|---|
| choronobiological nutritionProviding infant nutrition in accordance with crinobiological nutrition | Behavioural | choronobiological nutrition group |
Primary outcome
The change in the discharge time of newborns will be evaluated by using a questionnaire prepared by the researcher.
Time frame: The newborn will be evaluated once a week for up to an average of 6 weeks after the date of hospitalization.
newborn was evaluated during hospital treatment
1 secondary outcome
Weight gain of newborns will be evaluated using a questionnaire prepared by the investigator.
Time frame: The newborn will be evaluated once a week for up to an average of 6 weeks after the date of hospitalization.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing choronobiological nutrition in people with Nutrition, Healthy, run by Eskisehir Osmangazi University.
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 8 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: status not confirmed, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ezgi Ayvaz (05423787400, ezgiayvz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in the discharge time of newborns will be evaluated by using a questionnaire prepared by the researcher. (time frame: The newborn will be evaluated once a week for up to an average of 6 weeks after the date of hospitalization.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 May 2023.