Breast Feeding, ExclusiveNCT05923437
The Effect of Chronobiologic Feeding Model on Circadian Rhythm in Newborns
A study testing Feeding model group with a chronobiological approach in people with Breast Feeding, Exclusive and Hospitalization, run by Selcuk University at 2 sites in Turkey (Türkiye).
Trial summary
This study was planned to evaluate the effect of "feeding model with chronobiologic approach" on circadian rhythm, growth and physiologic parameters of newborns. Read more about this study
- Who is it for?
- Ages 28 to 42 weeks
- Conditions the study is for
- Breast Feeding, Exclusive, Hospitalization, Feeding Patterns
- What is being tested?
- Feeding model group with a chronobiological approach
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Aug 2023to 28 Feb 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 28 to 42 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age between 28-42 weeks
- Birth weight between 1500 and 4200 gr
- Hospitalization for at least 3 days
- Exclusive breastfeeding (oral/ enteral)
- Feeding at 3-hour intervals
- Stable health condition
- Spontaneous breathing
Who cannot join
- Babies fed outside of 3-hour intervals (hourly or two-hourly intervals)
- 5th minute apgar score below 4 at the time of delivery
- Resuscitation requirement
- Having a congenital anomaly
- Interventional intervention in the head region
- Central nervous system dysfunction
- Postpartum medical complications
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Kirsehir Ahi Evran University
Kırşehir
Edanur Tar, +903862804732, edanurtar.1107@gmail.com
- Recruiting
Selcuk University
Konya
Murat Konak, drmkonak@hotmail.com
About this study
Official title: Effect of Chronobıologıcal Approach Feedıng Model on Cırcadıan Rhythm, Growth and Physıologıcal Parameters in Newborn: A Randomızed Controlled Study
This study was planned to evaluate the effect of "feeding model with chronobiologic approach" on circadian rhythm, growth and physiologic parameters of newborns.
Read the detailed description
The newborn period is a period when all babies need their basic needs to be met and all babies are very sensitive physiologically, neuro-biologically and psycho-emotionally, but the newborn period is also a very important period in the development of circadian rhythm. It is important to establish a healthy sleep pattern for the formation of the circadian rhythm and the continuation of the functions of all other systems, especially the central nervous system. Formation of circadian rhythm in newborns; It shows a better development in the first 3 months with the effect of environmental factors such as nutrition, light, mother-baby interaction. Breast milk is a nutrient for the growth and development of babies, in addition, breast milk plays an active role in the formation of the baby's circadian rhythm by transmitting information about the time of day to the babies through components such as hormones and immune elements. In cases where breastfeeding is not possible, it is thought that the delivery of expressed breast milk to the babies simultaneously with the "feeding model with a chronobiological approach" has important effects on the sleep-wake cycle and growth and development. In studies examining circadian rhythm in newborns in the world and in our country, the limited number of studies evaluating the relationship between circadian rhythm and breast milk draws attention and further studies are recommended. However, there is no published study evaluating the effect of simultaneous administration of breast milk to the infant in line with the "feeding model with chronobiologic approach" on circadian rhythm, growth and physiologic parameters of newborns.
- Conditions
- Breast Feeding, Exclusive, Hospitalization, Feeding Patterns
- Being tested
- Feeding model group with a chronobiological approach
- Keywords
- Breast milk, Nutrition, Nursing, Chronobiology, Circadian rhythm, Sleep wake cycle, Newborn
- Medical subject headings
- Breast Feeding, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feeding model group with a chronobiological approachOther
Breast milk will be given to the newborns in the intervention group for 3 days in line with the "feeding model with a chronobiologic approach" simultaneously with the provision from the mother, and the newborn will be ensured to receive breast milk in accordance with the day cycle. Within the scope of the study, firstly, mothers and nurses in the NICU will be informed about the study. Mothers will be asked to put the milk mothers express between 06:00-17:59 in the "daytime breast milk storage bag" and the milk mothers express between 18:00-05:59 in the "nighttime breast milk storage bag" and bring them to the unit. The brought breast milk will be prepared by the nurses by matching "day and night" milk according to the dates, with the first milk brought in priority, and the newborns will be fed by using the "time of day factor" (cycle so that the milk collected during the day will be given during the day and the milk expressed at night will be given at night).
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Interventions Group | Experimental | Breast milk will be given to the newborns in the intervention group for 3 days in line with the "feeding model with a chronobiological approach", simultaneously with the mother's supply. Receives: Other: Feeding model group with a chronobiological approach |
| Control Group | No intervention | Breast milk will be given to newborns in the control group according to the clinical routine and infants will be followed up for 3 days. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Newborn Introductory Information Form
The form prepared by the researcher in line with the literature (Galland et al., 2012; Huang et al., 2021; Caba-Flores et al., 2022) consists of questions including the obstetric characteristics of the infant such as gender, gestational-postnatal age, type of delivery, APGAR scores, birth weight, height, head circumference, and the current clinical status of the infant such as diet, comorbidity, and total number of hospitalization days. The questionnaire form was sent to 5 academicians specialized in Pediatric Nursing, their expert opinions were obtained, and the questionnaire form was finalized by making the necessary changes in line with their suggestions. Information about the newborns in the control and experimental groups was collected by the researcher through the "Newborn Introductory Information Form" before the study, hospital records of the newborn and the primary nurse through face-to-face interview method will be collected in about 5 minutes.
Measured: First measurement - Before the study (before randomization)
Newborn Growth and Physiologic Parameters Follow-up Chart
"Temperature (°C), Pulse Rate (min), Blood Pressure (mmHg), Respiratory Rate (min), O2 Saturation (mmHg) will be recorded for 3 days during the day-night cycle of the infants followed in both groups. Physiologic parameters will be measured 1 hour after the 2nd daytime feeding and 1 hour after the 2nd nighttime feeding (i.e. after the baby's 6th feeding). The amount of breast milk received by the infant (ml)" will be monitored for three days separately in the daytime (06:00-17:59) and nighttime (18:00-05:59) cycle. In addition, the infants will be followed up in terms of "Body Weight (g), Height (cm), Head circumference (cm), Persentile" values until the infants are discharged from the hospital and all these parameters will be recorded through the "Newborn Growth and Physiological Parameters Follow-up Chart" created by the researcher.
Measured: First measurement - up the end of the first day night and day measurements
Newborn Circadian Rhythm Follow-up Chart
At the end of 3 days, the records of the duration of the babies' being in "Wakefulness, REM, N-REM / EVRE I, N-REM / EVRE II, N-REM / EVRE III, N-REM / EVRE III, N-REM / EVRE IV" measured by Bispectral Index (BIS) in 5-minute periods within a 24-hour time cycle will be taken from the BIS monitor records and entered into the "Newborn Circadian Rhythm Follow-up Chart" created by the researcher.
Measured: First measurement -up the end of the first day circadian rhythm measurements
Secondary outcomes (4)
Newborn Growth and Physiologic Parameters Follow-up Chart
"Temperature (°C), Pulse Rate (min), Blood Pressure (mmHg), Respiratory Rate (min), O2 Saturation (mmHg) will be recorded for 3 days during the day-night cycle of the infants followed in both groups. Physiologic parameters will be measured 1 hour after the 2nd daytime feeding and 1 hour after the 2nd nighttime feeding (i.e. after the baby's 6th feeding). The amount of breast milk received by the infant (ml)" will be monitored for three days separately in the daytime (06:00-17:59) and nighttime (18:00-05:59) cycle. In addition, the infants will be followed up in terms of "Body Weight (g), Height (cm), Head circumference (cm), Persentile" values until the infants are discharged from the hospital and all these parameters will be recorded through the "Newborn Growth and Physiological Parameters Follow-up Chart" created by the researcher.
Measured: Second measurement - up the end of the second day night and day measurements
Newborn Circadian Rhythm Follow-up Chart
At the end of 3 days, the records of the duration of the babies' being in "Wakefulness, REM, N-REM / EVRE I, N-REM / EVRE II, N-REM / EVRE III, N-REM / EVRE III, N-REM / EVRE IV" measured by Bispectral Index (BIS) in 5-minute periods within a 24-hour time cycle will be taken from the BIS monitor records and entered into the "Newborn Circadian Rhythm Follow-up Chart" created by the researcher.
Measured: Second measurement - up the end of the second day circadian rhythm measurements
Newborn Growth and Physiologic Parameters Follow-up Chart
"Temperature (°C), Pulse Rate (min), Blood Pressure (mmHg), Respiratory Rate (min), O2 Saturation (mmHg) will be recorded for 3 days during the day-night cycle of the infants followed in both groups. Physiologic parameters will be measured 1 hour after the 2nd daytime feeding and 1 hour after the 2nd nighttime feeding (i.e. after the baby's 6th feeding). The amount of breast milk received by the infant (ml)" will be monitored for three days separately in the daytime (06:00-17:59) and nighttime (18:00-05:59) cycle. In addition, the infants will be followed up in terms of "Body Weight (g), Height (cm), Head circumference (cm), Persentile" values until the infants are discharged from the hospital and all these parameters will be recorded through the "Newborn Growth and Physiological Parameters Follow-up Chart" created by the researcher.
Measured: Third measurement - up the end of the third day night and day measurements
Newborn Circadian Rhythm Follow-up Chart
At the end of 3 days, the records of the duration of the babies' being in "Wakefulness, REM, N-REM / EVRE I, N-REM / EVRE II, N-REM / EVRE III, N-REM / EVRE III, N-REM / EVRE IV" measured by Bispectral Index (BIS) in 5-minute periods within a 24-hour time cycle will be taken from the BIS monitor records and entered into the "Newborn Circadian Rhythm Follow-up Chart" created by the researcher.
Measured: Third measurement - up the end of the third day circadian rhythm measurements
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start1 Aug 2023
- Primary completion28 Feb 2024 (estimated)
- Study completion28 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast Feeding, ExclusiveStudies of the same condition, open and under way.
- More trials run by Selcuk 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will be conducted with a total of 40 newborns (intervention group=20, control group= 20). In order to prevent selection bias in the study, participants will be randomly assigned to the intervention and control groups and the "block randomization" method, one of the "fixed probability randomization" methods, will be used in randomization. Each of the intervention and control groups will be represented by one of the letters A and B. In the creation of the 4-block (2A, 2B); the assignment of 10 blocks from the total number of options determined using the "permutation" method will be carried out with the random numbers table tool on the www.random.org website.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sibel Küçükoğlu, Selcuk University
- Investigators
- Sibel Kucukoglu, Principal investigator, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05923437
- Sponsor's protocol ID
- SelcukUnı42
- Status last verified
- Dec 2023
- First submitted
- 20 Jun 2023
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It will be shared after the article is published.
Publications
Caba-Flores MD, Ramos-Ligonio A, Camacho-Morales A, Martinez-Valenzuela C, Viveros-Contreras R, Caba M. Breast Milk and the Importance of Chrononutrition. Front Nutr. 2022 May 12;9:867507. doi: 10.3389/fnut.2022.867507. eCollection 2022.
PubMed 35634367Huang Q, Lai X, Liao J, Tan Y. Effect of non-pharmacological interventions on sleep in preterm infants in the neonatal intensive care unit: A protocol for systematic review and network meta-analysis. Medicine (Baltimore). 2021 Oct 29;100(43):e27587. doi: 10.1097/MD.0000000000027587.
PubMed 34713833
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Chronobıologıcal Approach Feedıng Model on Cırcadıan Rhythm, Growth and Physıologıcal Parameters in Newborn: A Randomızed Controlled Study
- ClinicalTrials.gov ID
- NCT05923437
- Acronym / sponsor ID
- SelcukUnı42
- Conditions
- Breast Feeding, Exclusive, Hospitalization, Feeding Patterns
- Keywords
- Breast milk, Nutrition, Nursing, Chronobiology, Circadian rhythm, Sleep wake cycle, Newborn
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 28 Feb 2024 (estimated)
- Study completion
- 28 Feb 2024 (estimated)
- First posted
- 28 Jun 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.
This study was planned to evaluate the effect of "feeding model with chronobiologic approach" on circadian rhythm, growth and physiologic parameters of newborns.
Detailed description
The newborn period is a period when all babies need their basic needs to be met and all babies are very sensitive physiologically, neuro-biologically and psycho-emotionally, but the newborn period is also a very important period in the development of circadian rhythm. It is important to establish a healthy sleep pattern for the formation of the circadian rhythm and the continuation of the functions of all other systems, especially the central nervous system. Formation of circadian rhythm in newborns; It shows a better development in the first 3 months with the effect of environmental factors such as nutrition, light, mother-baby interaction. Breast milk is a nutrient for the growth and development of babies, in addition, breast milk plays an active role in the formation of the baby's circadian rhythm by transmitting information about the time of day to the babies through components such as hormones and immune elements. In cases where breastfeeding is not possible, it is thought that the delivery of expressed breast milk to the babies simultaneously with the "feeding model with a chronobiological approach" has important effects on the sleep-wake cycle and growth and development. In studies examining circadian rhythm in newborns in the world and in our country, the limited number of studies evaluating the relationship between circadian rhythm and breast milk draws attention and further studies are recommended. However, there is no published study evaluating the effect of simultaneous administration of breast milk to the infant in line with the "feeding model with chronobiologic approach" on circadian rhythm, growth and physiologic parameters of newborns.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study will be conducted with a total of 40 newborns (intervention group=20, control group= 20). In order to prevent selection bias in the study, participants will be randomly assigned to the intervention and control groups and the "block randomization" method, one of the "fixed probability randomization" methods, will be used in randomization. Each of the intervention and control groups will be represented by one of the letters A and B. In the creation of the 4-block (2A, 2B); the assignment of 10 blocks from the total number of options determined using the "permutation" method will be carried out with the random numbers table tool on the www.random.org website.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Interventions Group | Experimental | Other: Feeding model group with a chronobiological approachBreast milk will be given to the newborns in the intervention group for 3 days in line with the "feeding model with a chronobiological approach", simultaneously with the mother's supply. |
| Control Group | No intervention | –Breast milk will be given to newborns in the control group according to the clinical routine and infants will be followed up for 3 days. |
Who may qualify
- Ages
- 28 to 42 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Gestational age between 28-42 weeks
- Birth weight between 1500 and 4200 gr
- Hospitalization for at least 3 days
- Exclusive breastfeeding (oral/ enteral)
- Feeding at 3-hour intervals
Key exclusion criteria (7 listed)
- Babies fed outside of 3-hour intervals (hourly or two-hourly intervals)
- 5th minute apgar score below 4 at the time of delivery
- Resuscitation requirement
- Having a congenital anomaly
- Interventional intervention in the head region
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 |
|---|---|---|
| Feeding model group with a chronobiological approachBreast milk will be given to the newborns in the intervention group for 3 days in line with the "feeding model with a chronobiologic approach" simultaneously with the provision from the mother, and the newborn will be ensured to receive breast milk in accordance with the day cycle. Within the scope of the study, firstly, mothers and nurses in the NICU will be informed about the study. Mothers will be asked to put the milk mothers express between 06:00-17:59 in the "daytime breast milk storage bag" and the milk mothers express between 18:00-05:59 in the "nighttime breast milk storage bag" and bring them to the unit. The brought breast milk will be prepared by the nurses by matching "day and night" milk according to the dates, with the first milk brought in priority, and the newborns will be fed by using the "time of day factor" (cycle so that the milk collected during the day will be given during the day and the milk expressed at night will be given at night). | Other | Experimental: Interventions Group |
Primary outcome
Newborn Introductory Information Form
Time frame: First measurement - Before the study (before randomization)
The form prepared by the researcher in line with the literature (Galland et al., 2012; Huang et al., 2021; Caba-Flores et al., 2022) consists of questions including the obstetric characteristics of the infant such as gender, gestational-postnatal age, type of delivery, APGAR scores, birth weight, height, head circumference, and the current clinical status of the infant such as diet, comorbidity, and total number of hospitalization days. The questionnaire form was sent to 5 academicians specialized in Pediatric Nursing, their expert opinions were obtained, and the questionnaire form was finalized by making the necessary changes in line with their suggestions. Information about the newborns in the control and experimental groups was collected by the researcher through the "Newborn Introductory Information Form" before the study, hospital records of the newborn and the primary nurse through face-to-face interview method will be collected in about 5 minutes.
Newborn Growth and Physiologic Parameters Follow-up Chart
Time frame: First measurement - up the end of the first day night and day measurements
"Temperature (°C), Pulse Rate (min), Blood Pressure (mmHg), Respiratory Rate (min), O2 Saturation (mmHg) will be recorded for 3 days during the day-night cycle of the infants followed in both groups. Physiologic parameters will be measured 1 hour after the 2nd daytime feeding and 1 hour after the 2nd nighttime feeding (i.e. after the baby's 6th feeding). The amount of breast milk received by the infant (ml)" will be monitored for three days separately in the daytime (06:00-17:59) and nighttime (18:00-05:59) cycle. In addition, the infants will be followed up in terms of "Body Weight (g), Height (cm), Head circumference (cm), Persentile" values until the infants are discharged from the hospital and all these parameters will be recorded through the "Newborn Growth and Physiological Parameters Follow-up Chart" created by the researcher.
Newborn Circadian Rhythm Follow-up Chart
Time frame: First measurement -up the end of the first day circadian rhythm measurements
At the end of 3 days, the records of the duration of the babies' being in "Wakefulness, REM, N-REM / EVRE I, N-REM / EVRE II, N-REM / EVRE III, N-REM / EVRE III, N-REM / EVRE IV" measured by Bispectral Index (BIS) in 5-minute periods within a 24-hour time cycle will be taken from the BIS monitor records and entered into the "Newborn Circadian Rhythm Follow-up Chart" created by the researcher.
4 secondary outcomes
Newborn Growth and Physiologic Parameters Follow-up Chart
Time frame: Second measurement - up the end of the second day night and day measurements
Newborn Circadian Rhythm Follow-up Chart
Time frame: Second measurement - up the end of the second day circadian rhythm measurements
Newborn Growth and Physiologic Parameters Follow-up Chart
Time frame: Third measurement - up the end of the third day night and day measurements
Newborn Circadian Rhythm Follow-up Chart
Time frame: Third measurement - up the end of the third day circadian rhythm measurements
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
- Results publication: PubMed 35634367Caba-Flores MD, Ramos-Ligonio A, Camacho-Morales A, Martinez-Valenzuela C, Viveros-Contreras R, Caba M. Breast Milk and the Importance of Chrononutrition. Front Nutr. 2022 May 12;9:867507. doi: 10.3389/fnut.2022.867507. eCollection 2022.
- Results publication: PubMed 34713833Huang Q, Lai X, Liao J, Tan Y. Effect of non-pharmacological interventions on sleep in preterm infants in the neonatal intensive care unit: A protocol for systematic review and network meta-analysis. Medicine (Baltimore). 2021 Oct 29;100(43):e27587. doi: 10.1097/MD.0000000000027587.
- Individual participant dataSharing planned: No. It will be shared after the article is published.
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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.
Sibel Kucukoglu principal investigator
Selcuk University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Feeding model group with a chronobiological approach in people with Breast Feeding, Exclusive and Hospitalization, run by Selcuk University at 2 sites 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 7 inclusion and 7 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 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sibel Kucukoglu (+903322231623, s_nadaroglu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Newborn Introductory Information Form (time frame: First measurement - Before the study (before randomization)). The study lists 3 primary outcomes in all. 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 NCT05923437, which also lists 2 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 19 Dec 2023.