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

Breast Feeding Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06342674
• Other study ID #: Nejla CANBULAT SAHINER
• Status: Recruiting
• Phase: N/A
• Start date: January 25, 2024
• Est. completion date: July 31, 2025

Study information

• Verified date: April 2024
• Source: Sakarya University
• Contact: Nejla Canbulat Sahiner, Prof.Dr.
• Phone: +90 (338) 226 20 00
• Email: ncanbulat[@]kmu.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: July 31, 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 32 Weeks to 34 Weeks

Eligibility

Inclusion Criteria:

• 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)
• 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:

• 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). 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

Related Conditions & MeSH terms

• Breast Feeding
• Breast Milk Collection

Intervention

Other:
• 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

Locations

Country	Name	City	State
Turkey	Karamanoglu Mehmet Bey University	Karaman

Sponsors (1)

Lead Sponsor	Collaborator
Sakarya University

Country where clinical trial is conducted

Turkey, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Menekse, D., Çinar, N.2017. "Çogul Bebeklerde Emzirme", Turkiye Klinikleri J Pediatr Nurs-Special Topics. 3,2, 91-103.

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. — View Citation

Ovali, F. 2018. "0-1 yas bebeklerde vitamin, mineral ve eser element destegi", Klinik Tip Pediatri Dergisi, 10,1, 1-6.

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Difference between the first measurement before application (in birth) and the body weight measurement at discharge (an average of one month after birth)
Primary	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.	Difference between the first measurement before application (in birth)and the body height measurement at discharge (an average of one month after birth)
Primary	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	Difference between the first measurement before application (in birth) and head circumference measurement at discharge (an average of one month after birth)
Secondary	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	Difference between first measurement (postpartum) (in birth) and second measurement (at discharge) (an average of one month after birth)