PretermNCT06821672
The Effect of Oral Feeding Model With a Chronobiological Approach in Neonates
A study testing Chronobiological Group in people with Preterm and Chronobiology, run by Istanbul Bilgi University at 1 site in Turkey (Türkiye).
Trial summary
The ideal food for healthy term babies as well as preterm babies and sick term babies is breast milk. There are many studies showing that the composition of breast milk can vary from mother to mother, according to the baby's gestational age and gender. Read more about this study
- Who is it for?
- Ages 32 to 37 weeksHealthy volunteers can take part
- Conditions the study is for
- Preterm, Chronobiology, Human Milk/Breastfeeding
- What is being tested?
- Chronobiological Group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Dec 2023to 15 May 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 32 to 37 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants with family consent,
- 32 0/6 - 36 6/7 weeks of gestation,
- Exclusively breastfed,
- Infants who have switched to full oral feeding
Who cannot join
- Intravenous fluid therapy,
- Feeding intolerance
- Sepsis, Necrotizing enterocolitis, Major congenital anomaly,
- Mechanical ventilation support.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Bilgi University
Şişli, Istanbul, 34387
About this study
Official title: The Effect of Chronobiological Feeding Model on Sleep and Physiological Conditions of Neonates: A Randomized Controlled Study"
The ideal food for healthy term babies as well as preterm babies and sick term babies is breast milk. There are many studies showing that the composition of breast milk can vary from mother to mother, according to the baby's gestational age and gender. New studies on the content of breast milk suggest that breast milk is different during the day and at night, that micro and macronutrient content, hormones and some enzymes are secreted at different levels at different times of the day and that breast milk has a circadian rhythm.
This study was designed as a prospective, randomized, controlled study. The study will be conducted to evaluate the effect of the Chronobiological Approach Feeding Model application on the baby's sleep characteristics and physiological conditions in preterm babies hospitalized in the Neonatal Intensive Care Unit (NICU).
Read more
The simple randomization method will be used in the study and the babies will be divided into intervention (n=30) and control (n=30) groups. The study was conducted with 60 infants followed in the neonatal intensive care unit.
The milk of the intervention group patients will be given to the babies by matching them circadianly , while the milk of the control group patients will be given without matching according to clinical routine practice. Demographic data and sleep measurements (time and quality) of all infants will be recorded in the "Baby Monitoring Form" created by the researcher.
Read the detailed description
Circadian fluctuations in breast milk content are very important in preterm infants fed with breast milk. The composition of breast milk changes throughout the day. There is no randomized controlled study in the literature suggesting that breast milk should be matched to the infant's circadian. This study aimed to evaluate the effect of the Chronobiological Nutrition Model application on the sleep characteristics and physiological conditions of preterm infants in the neonatal intensive care unit. It is aimed to increase the sleep duration and depth of infants, shorten the crying periods and increase the quality of nursing practices by circadian matching with breast milk in the feeding of preterm infants.
- Conditions
- Preterm, Chronobiology, Human Milk/Breastfeeding, Bottle Feeding, Sleep Disorders, Circadian Rhythm
- Being tested
- Chronobiological Group
- Keywords
- preterm Human milk Circadian rhythm neonate, sleep, cry
- Medical subject headings
- Premature Birth, Bottle Feeding, Sleep Disorders, Circadian Rhythm, Crying
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chronobiological GroupProcedure or surgery
In the intervention group, a label containing the time of expressed breastmilk will be affixed. In the milk preparation room, breast milk will be stored in a separate refrigerator as 08:00-19:59 day milk and 20:00-07:59 night milk.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | No Intervention: Control Group Preterm infants in the NICU are fed with breast milk and bottles. Although the date is written on the expressed breast milk, it is usually not given after checking the time of day. The experiment is about labeling the breast milk according to the time of day before giving it to the babies. No extra intervention is made during feeding. The breast milk of the control group patients will be given without being matched according to the clinical routine practice. Demographic data, measurements of sleep characteristics (time and quality), and characteristics of physiological status will be recorded on the "Baby Monitoring Form" created by the researcher. |
| Intervention Group | Experimental | Experimental: Chronobiological Approach Nutrition Model Preterm infants in NICU are fed with breast milk and bottle. Although the date is written on expressed breast milk, it is usually not given by checking its suitability for the time of day. The milk of the intervention group patients will be matched circadian and given to the babies. Intervention group's breast milk is labeling by time of day before the each feeding. In the intervention group, a label containing the time of expressed breastmilk will be affixed. Circadian matched milk will be provided at each feeding. intervention is;n the intervention group, a label containing the time of expressed breastmilk will be affixed. In the milk preparation room, breast milk will be stored in a separate refrigerator as 08:00-19:59 day milk and 20:00-07:59 night milk. Demographic data, measurements of sleep characteristics (duration and quality), and characteristics of physiological status will be recorded on the "Baby Monitoring Form" Receives: Procedure: Chronobiological Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep time
Effect of Chronobiological Approach Feeding Model on infant sleep time during circadian matched breastfeeding sleep time in hours
Measured: 24 hour
Crying time
Effect of Chronobiological Approach Feeding Model on infant crying duration measured during circadian matched breastfeeding crying duration in hours
Measured: 24 hour
Secondary outcomes (1)
Discharge time
The effect of Chronobiological Approach Nutrition Model application on infant's hospital stay
Measured: through study completion, an average of 30 days]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start20 Dec 2023
- Primary completion20 Dec 2023
- Study completion15 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PretermStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled two groups (control group and study group)
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Bilgi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ebru temizsoy, Istanbul Bilgi University
- Investigators
- ebru temizsoy, PhD, Principal investigator, İstanbul Bilgi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06821672
- Sponsor's protocol ID
- 2023/0161
- Status last verified
- Feb 2025
- First submitted
- 6 Feb 2025
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Chronobiological Feeding Model on Sleep and Physiological Conditions of Neonates: A Randomized Controlled Study"
- ClinicalTrials.gov ID
- NCT06821672
- Acronym / sponsor ID
- 2023/0161
- Conditions
- Preterm, Chronobiology, Human Milk/Breastfeeding, Bottle Feeding, Sleep Disorders, Circadian Rhythm
- Keywords
- preterm Human milk Circadian rhythm neonate, sleep, cry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istanbul Bilgi UniversityUniversity, hospital or other
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 15 May 2024 (actual)
- First posted
- 12 Feb 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 ideal food for healthy term babies as well as preterm babies and sick term babies is breast milk. There are many studies showing that the composition of breast milk can vary from mother to mother, according to the baby's gestational age and gender. New studies on the content of breast milk suggest that breast milk is different during the day and at night, that micro and macronutrient content, hormones and some enzymes are secreted at different levels at different times of the day and that breast milk has a circadian rhythm.
This study was designed as a prospective, randomized, controlled study. The study will be conducted to evaluate the effect of the Chronobiological Approach Feeding Model application on the baby's sleep characteristics and physiological conditions in preterm babies hospitalized in the Neonatal Intensive Care Unit (NICU).
The simple randomization method will be used in the study and the babies will be divided into intervention (n=30) and control (n=30) groups. The study was conducted with 60 infants followed in the neonatal intensive care unit.
The milk of the intervention group patients will be given to the babies by matching them circadianly , while the milk of the control group patients will be given without matching according to clinical routine practice. Demographic data and sleep measurements (time and quality) of all infants will be recorded in the "Baby Monitoring Form" created by the researcher.
Detailed description
Circadian fluctuations in breast milk content are very important in preterm infants fed with breast milk. The composition of breast milk changes throughout the day. There is no randomized controlled study in the literature suggesting that breast milk should be matched to the infant's circadian. This study aimed to evaluate the effect of the Chronobiological Nutrition Model application on the sleep characteristics and physiological conditions of preterm infants in the neonatal intensive care unit. It is aimed to increase the sleep duration and depth of infants, shorten the crying periods and increase the quality of nursing practices by circadian matching with breast milk in the feeding of preterm infants.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Randomized Controlled two groups (control group and study group)
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –No Intervention: Control Group Preterm infants in the NICU are fed with breast milk and bottles. Although the date is written on the expressed breast milk, it is usually not given after checking the time of day. The experiment is about labeling the breast milk according to the time of day before giving it to the babies. No extra intervention is made during feeding. The breast milk of the control group patients will be given without being matched according to the clinical routine practice. Demographic data, measurements of sleep characteristics (time and quality), and characteristics of physiological status will be recorded on the "Baby Monitoring Form" created by the researcher. |
| Intervention Group | Experimental | Procedure: Chronobiological GroupExperimental: Chronobiological Approach Nutrition Model Preterm infants in NICU are fed with breast milk and bottle. Although the date is written on expressed breast milk, it is usually not given by checking its suitability for the time of day. The milk of the intervention group patients will be matched circadian and given to the babies. Intervention group's breast milk is labeling by time of day before the each feeding. In the intervention group, a label containing the time of expressed breastmilk will be affixed. Circadian matched milk will be provided at each feeding. intervention is;n the intervention group, a label containing the time of expressed breastmilk will be affixed. In the milk preparation room, breast milk will be stored in a separate refrigerator as 08:00-19:59 day milk and 20:00-07:59 night milk. Demographic data, measurements of sleep characteristics (duration and quality), and characteristics of physiological status will be recorded on the "Baby Monitoring Form" |
Who may qualify
- Ages
- 32 to 37 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Infants with family consent,
- 32 0/6 - 36 6/7 weeks of gestation,
- Exclusively breastfed,
- Infants who have switched to full oral feeding
Key exclusion criteria (4 listed)
- Intravenous fluid therapy,
- Feeding intolerance
- Sepsis, Necrotizing enterocolitis, Major congenital anomaly,
- Mechanical ventilation support.
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 |
|---|---|---|
| Chronobiological GroupIn the intervention group, a label containing the time of expressed breastmilk will be affixed. In the milk preparation room, breast milk will be stored in a separate refrigerator as 08:00-19:59 day milk and 20:00-07:59 night milk. | Procedure or surgery | Intervention Group |
Primary outcome
Sleep time
Time frame: 24 hour
Effect of Chronobiological Approach Feeding Model on infant sleep time during circadian matched breastfeeding sleep time in hours
Crying time
Time frame: 24 hour
Effect of Chronobiological Approach Feeding Model on infant crying duration measured during circadian matched breastfeeding crying duration in hours
1 secondary outcome
Discharge time
Time frame: through study completion, an average of 30 days]
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 12 Feb 2025.
- 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.
ebru temizsoy, PhD principal investigator
İstanbul Bilgi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chronobiological Group in people with Preterm and Chronobiology, run by Istanbul Bilgi 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 4 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 12 Feb 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?
Sleep time (time frame: 24 hour). The study lists 2 primary outcomes in all. 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 12 Feb 2025.