Effect of Breast Milk Circadian Properties on Infant's Growth Parameters and Absorption of Nutrients
NCT ID: NCT06342674
Last Updated: 2024-05-01
Study Results
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Basic Information
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RECRUITING
NA
44 participants
INTERVENTIONAL
2024-01-25
2025-07-31
Brief Summary
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no effect on the infant's growth parameters and nutrient absorption levels by the infant.
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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Experimental Group
While 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.
Giving breast milk to the newborn according to the circadian rhythm
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
Control Groups
In 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.
Usual care
Newborns in the control group will be given expressed milk first, in line with the routine practice of the clinic
Interventions
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Giving breast milk to the newborn according to the circadian rhythm
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 care
Newborns in the control group will be given expressed milk first, in line with the routine practice of the clinic
Eligibility Criteria
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Inclusion Criteria
* 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)
* 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)
Exclusion Criteria
* 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).
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
32 Weeks
34 Weeks
ALL
Yes
Sponsors
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Sakarya University
OTHER
Responsible Party
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dilek menekşe
Assistant professor
Principal Investigators
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Nejla Canbulat Şahiner, Prof.Dr.
Role: STUDY_DIRECTOR
Karamanoğlu Mehmet Bey University
Ayşe Sonay Türkmen, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Karamanoğlu Mehmet Bey University
Dilek Menekşe, Asst. prof.
Role: PRINCIPAL_INVESTIGATOR
Sakarya University
Hacer Sibel Karapınar, Assoc. Prof.
Role: PRINCIPAL_INVESTIGATOR
Karamanoğlu Mehmet Bey University
Murat Konak, Assoc. Prof.
Role: PRINCIPAL_INVESTIGATOR
Selçuk University
Havvanur Bayam, Nutritionist
Role: PRINCIPAL_INVESTIGATOR
Selçuk University
Locations
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Karamanoğlu Mehmet Bey University
Karaman, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Nejla CANBULAT ŞAHİNER, Prof. Dr.
Role: primary
References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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Nejla CANBULAT ŞAHİNER
Identifier Type: -
Identifier Source: org_study_id
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