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Breast FeedingTheNCT06342674

Effect of Breast Milk Circadian Properties on Infant's Growth Parameters and Absorption of Nutrients

A study testing Giving breast milk to the newborn according to the circadian rhythm in people with Breast Feeding and Breast Milk Collection, run by Sakarya University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The most ideal method for providing breast milk is breastfeeding. However, it may be necessary to express breast milk for reasons such as the newborn being in an intensive care unit, the mother being hospitalized for any reason, or the mother starting to work. Read more about this study

Who is it for?
Ages 32 to 34 weeksHealthy volunteers can take part
Conditions the study is for
Breast Feeding, Breast Milk Collection
What is being tested?
Giving breast milk to the newborn according to the circadian rhythm
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteTurkey (Türkiye)
Study dates
25 Jan 2024to 31 Jul 2025
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 34 weeks
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • The mother is healthy (without a history of preeclampsia, hypertension, diabetes, hepatitis B or C, HIV, tuberculosis, mastitis or oncological disease)
  • The mother's birth is 32-34 between weeks of gestation
  • The mother does not follow a special diet
  • The mother is not a vegetarian
  • The mother does not smoke
  • The mother must have a body mass index within normal limits (BMI = 18.50-24.99) (WHO, 2022b)
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  • Income must be at or above the monthly minimum wage
  • The mother cannot breastfeed her baby and routinely expresses her own milk every three hours.
  • The mother expresses her milk with a milking machine (milking will be done with the same brand device and the same level of suction power).
  • The baby is in the neonatal intensive care unit
  • Feeding the infant by gavage and oral method
  • In order for the preterm newborn to be fed effectively and safely orally, it is necessary for the preterm baby to be able to coordinate sucking-swallowing as well as breathing (Tian et al., 2015). Gavage feeding is a priority in babies who have this coordination (TND, 2018). In babies who have the coordination of sucking, swallowing and breathing, oral feeding will be started after an assessment of readiness for oral feeding will be made.
  • Full enterally fed babies
  • The infant does not have a health problem that requires surgical treatment
  • 10th-90th percentile curves according to the infant's gestational age. percentile (those with normal birth weight for gestational age: Appropriate for Gestational Age -AGA)

Who cannot join

  • The mother receives medication (antibiotics, etc.) treatment
  • Interruption of the mother's milk during the working period
  • Low birth weight of the baby according to the intrauterine growth curve
  • Feeding the baby with formula
  • Total parenterally fed babies
  • The baby has a small birth weight for the gestational age (Small for Gestational Age - SGA) and a baby with a large birth weight for the gestational age (LGA).
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  • Criteria for Exclusion from the Study;
  • The mother received medication (antibiotics, etc.) during the data collection process.
  • The mother does not want to continue
  • Respiratory problems, hypoglycemia, hyperbilirubinemia, etc. in preterm babies. occurrence of various problems

Trial locations and contacts

1 site in 1 country.

Nejla Canbulat Şahiner, Prof.Dr. contact

+90 (338) 226 20 00 ext. 4275

ncanbulat@kmu.edu.tr

Turkey (Türkiye)1 site, 1 recruiting

  • Karamanoğlu Mehmet Bey University

    Karaman

    Nejla CANBULAT ŞAHİNER, Prof. Dr.

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Effect of Breast Milk Circadian Properties on Infant Growth Parameters and Nutrient Absorption in Preterm Newborns

The most ideal method for providing breast milk is breastfeeding. However, it may be necessary to express breast milk for reasons such as the newborn being in an intensive care unit, the mother being hospitalized for any reason, or the mother starting to work. The content of breast milk varies according to gestational age and stages of lactation. However, it varies from day to day depending on the infant's needs. In recent literature, it is emphasized that the content of breast milk (carbohydrates, fats, proteins, vitamins, trace elements, etc.) varies according to circadian variation. In the literature review, no national or international study was found indicating whether the circadian properties of breast milk have an effect on the infant's growth parameters. This study was designed as a randomized controlled experimental study to determine the effect of the circadian properties of breast milk on the growth parameters of the infant and the absorption levels of nutrients by the baby in preterm newborns.

no effect on the infant's growth parameters and nutrient absorption levels by the infant.

Read more

Hypothesis 1 (H1): Feeding preterm newborns with breast milk according to the circadian rhythm has an effect on the weight of the infants.

Hypothesis 2 (H2): Feeding preterm newborns with breast milk according to the circadian rhythm has an effect on the height of the infants.

Hypothesis 3 (H3): Feeding preterm newborns with breast milk according to the circadian rhythm has an effect on the head circumference of the infants.

Hypothesis 4 (H4): Feeding preterm newborns with breast milk according to the circadian rhythm has an effect on the absorption levels of vitamins and trace elements measured in the infants' breast milk.

Read the detailed description

Breast milk is an ideal and unique food with excellent content for the healthy growth and development of both term and preterm babies. Breast milk, which is considered the "Gold Standard" in term and preterm baby nutrition, has a complex, lively and dynamic structure. The content of breast milk varies from day to day and according to the gestational age, stages of lactation, and the baby's needs. These differences indicate that breast milk is a unique food.

Breast milk contains many complex nutrients, and while the amount of some nutrients varies depending on the mother's diet, lactation day and duration, some nutrients remain at relatively constant levels. Breast milk contains macronutrients (carbohydrates, proteins, fats), micronutrients (vitamins, trace elements and electrolytes) and bioactive factors (various hormones, immune factors and other bioactive factors). In recent years, the difference in the content of breast milk according to circadian variation has been evaluated. In studies examining breast milk content according to circadian variation, it was stated that total carbohydrate concentration did not show circadian change.It has been determined that the fat concentrations in breast milk, which are necessary for the growth and development of the baby, indicate the existence of circadian variation. However, there are different results in element and vitamin studies. In cases where breast milk should be given by expressing, not giving milk in accordance with the circadian rhythm may disrupt the developing circadian rhythms of babies, potentially causing sleep problems and decreased physiological harmony with their parents/environment. This situation may negatively affect the baby's growth and development and endanger its health. In light of this information; The study was planned to determine the effect of the circadian properties of breast milk on the growth parameters of the baby and the absorption levels of nutrients by the baby in preterm newborns.

Being tested
Giving breast milk to the newborn according to the circadian rhythm, Usual care
Keywords
Breast milk, circadian rhythm, growth, preterm, newborn
Medical subject headings
Breast Feeding, Breast Milk Expression, Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Giving breast milk to the newborn according to the circadian rhythmOther

    It is the delivery of milk expressed by the newborn's mother during the neonatal intensive care unit, in accordance with the time of expression. Breast milk follows the circadian rhythm, that is, the milk the mother expresses at night will be given to her infant at night, and the milk she expresses during the day will be given to her infant during the day

  • Usual careOther

    Newborns in the control group will be given expressed milk first, in line with the routine practice of the clinic

Study groups in NCT06342674
Study groupRoleWhat they receive
Experimental GroupExperimentalWhile the mothers' babies are in the neonatal intensive care unit, the babies in the circadian rhythm group will be fed by taking into account the date and day/night practice. The milk that the mother expresses at night will be given to her baby at night, and the milk that she expresses during the day will be used for daytime feeding. Milk expressed 24 hours a day is delivered to the baby in 4 time periods (06:00-12:00, 12:00-18:00, 18:00-24:00, 24:00-06:00) in coordination with the time it is expressed. It is planned to be given (Italianer et al., 2020).For example, the milk expressed at 02:00 at night on 15.08.2023 and at 05:00 at night on 16.08.2023 will be given to the baby first with the milk of the previous date of 15.08.2023, in the period of 24:00-06:00 at night. Breast milk will be given according to both date and day/night milk concept.
Receives: Other: Giving breast milk to the newborn according to the circadian rhythm
Control GroupsExperimentalIn the control group, the condition of "expressed milk is given first", which is used in routine practice, will be fulfilled, regardless of the day and night characteristics of expressed breast milk. The routine practice of the clinic will continue.
Receives: Other: Usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluation of the newborn's body weight in the study and control groups Evaluation of the newborn's body weight in the study and control groups Evaluation of the newborn's body weight in the study and control groups

    A calibrated scale, capable of weighing accurately to 10 grams, will be used to measure the weight of infants. During the process, a disposable cover will be placed on the scale to be measured, and the scale will be set to "0". The baby's clothes will be removed and the baby will be measured naked except for the dry diaper. If a dry diaper is left, the weight of the diaper will be deducted from the child's body weight. Measurements will be made once every two days for four weeks.

    Measured: Difference between the first measurement before application (in birth) and the body weight measurement at discharge (an average of one month after birth)

  2. Evaluation of the baby's height measurements in the study and control groups

    A height meter will be used to measure the height of babies. Height measurements of babies will be made in the supine position. If the baby has any booties, shoes or hat, they will be removed and the measurement will be performed. Care must be taken to ensure that the ground on which the measurement will be made is hard and horizontal. The baby's head will be kept in contact with the fixed board, and the other will be measured by sliding the moving part to the baby's sole. Measurements will be made once every two days for four weeks.

    Measured: Difference between the first measurement before application (in birth)and the body height measurement at discharge (an average of one month after birth)

  3. Evaluation of the baby's head circumference in the study and control groups

    A tape measure will be used to measure babies' head circumference. Measurement of the baby's head circumference; It will be measured by passing the non-flexible tape measure over the most protruding occiput bone at the back of the head, over the ears on the side, and over the eyebrows in front. Measurements will be made once every two days for four weeks

    Measured: Difference between the first measurement before application (in birth) and head circumference measurement at discharge (an average of one month after birth)

Secondary outcomes (1)

  1. Evaluation of nutritional absorption of infants in the study and control groups

    25-30 ml of breast milk will be used for all milk analyses. Breast milk melatonin hormone levels will be analyzed by Enzyme Plate Reader by taking 50 µl of milk and using the ELISA kit.Serum content parameters of the mother and the newborn will be evaluated. During the routine practice of the clinic, blood samples from the mother and the baby will be taken after birth (for the first time) and at discharge (approximately 1 month later). After the blood samples are used for laboratory analysis in accordance with the requests of the clinic, the remaining samples will be taken from the laboratory (1 ml), sampled separately for serum, vitamin and trace element analyzes and transferred to storage bottles with a pipette. Nutrient analyzes will be performed by Inductively Coupled Plasma-Optical Emission Spectrometry and High Performance Liquid Chromatography

    Measured: Difference between first measurement (postpartum) (in birth) and second measurement (at discharge) (an average of one month after birth)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2024
  2. Study start25 Jan 2024
  3. Primary completion1 Apr 2025 (estimated)
  4. Study completion31 Jul 2025 (estimated)

Resources

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 Trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06342674
Sponsor's protocol ID
Nejla CANBULAT ŞAHİNER
Acronym
The
Status last verified
Apr 2024
First submitted
20 Jan 2024
Last updated
1 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Menekşe, D., Çınar, N.2017. "Çoğul Bebeklerde Emzirme", Turkiye Klinikleri J Pediatr Nurs-Special Topics. 3,2, 91-103.

  • Italianer MF, Naninck EFG, Roelants JA, van der Horst GTJ, Reiss IKM, Goudoever JBV, Joosten KFM, Chaves I, Vermeulen MJ. Circadian Variation in Human Milk Composition, a Systematic Review. Nutrients. 2020 Aug 4;12(8):2328. doi: 10.3390/nu12082328.

    PubMed 32759654

  • Gidrewicz DA, Fenton TR. A systematic review and meta-analysis of the nutrient content of preterm and term breast milk. BMC Pediatr. 2014 Aug 30;14:216. doi: 10.1186/1471-2431-14-216.

    PubMed 25174435

  • Sahin S, Ozdemir T, Katipoglu N, Akcan AB, Kaynak Turkmen M. Comparison of Changes in Breast Milk Macronutrient Content During the First Month in Preterm and Term Infants. Breastfeed Med. 2020 Jan;15(1):56-62. doi: 10.1089/bfm.2019.0141. Epub 2019 Nov 25.

    PubMed 31765240

  • Ovalı, F. 2018. "0-1 yaş bebeklerde vitamin, mineral ve eser element desteği", Klinik Tıp Pediatri Dergisi, 10,1, 1-6.

  • McNaughton L, Davies P. The effects of a 16 week aerobic conditioning program on serum lipids, lipoproteins and coronary risk factors. J Sports Med Phys Fitness. 1987 Sep;27(3):296-302. No abstract available.

    PubMed 3431112

  • Moran-Lev H, Mimouni FB, Ovental A, Mangel L, Mandel D, Lubetzky R. Circadian Macronutrients Variations over the First 7 Weeks of Human Milk Feeding of Preterm Infants. Breastfeed Med. 2015 Sep;10(7):366-70. doi: 10.1089/bfm.2015.0053. Epub 2015 Jul 29.

    PubMed 26222826

  • Hollanders JJ, Kouwenhoven SMP, van der Voorn B, van Goudoever JB, Rotteveel J, Finken MJJ. The Association between Breastmilk Glucocorticoid Concentrations and Macronutrient Contents Throughout the Day. Nutrients. 2019 Jan 24;11(2):259. doi: 10.3390/nu11020259.

    PubMed 30682836

  • Hampel D, Shahab-Ferdows S, Islam MM, Peerson JM, Allen LH. Vitamin Concentrations in Human Milk Vary with Time within Feed, Circadian Rhythm, and Single-Dose Supplementation. J Nutr. 2017 Apr;147(4):603-611. doi: 10.3945/jn.116.242941. Epub 2017 Feb 15.

    PubMed 28202638

  • Hahn-Holbrook J, Saxbe D, Bixby C, Steele C, Glynn L. Human milk as "chrononutrition": implications for child health and development. Pediatr Res. 2019 Jun;85(7):936-942. doi: 10.1038/s41390-019-0368-x. Epub 2019 Mar 11.

    PubMed 30858473

Questions about this trial

What is this clinical trial studying?

A study testing Giving breast milk to the newborn according to the circadian rhythm in people with Breast Feeding and Breast Milk Collection, run by Sakarya 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 15 inclusion and 10 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 1 May 2024. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Nejla Canbulat Şahiner, Prof.Dr. (+90 (338) 226 20 00 ext. 4275, ncanbulat@kmu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of the newborn's body weight in the study and control groups Evaluation of the newborn's body weight in the study and control groups Evaluation of the newborn's body weight in the study and control groups (time frame: Difference between the first measurement before application (in birth) and the body weight measurement at discharge (an average of one month after birth)). 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 NCT06342674, which also lists 10 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 1 May 2024.

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