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

NCT06342674 | Recruiting

• 1 other identifier: Nejla CANBULAT ŞAHİNER
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Feeding; Breast Milk Collection

Keywords

Breast milk; circadian rhythm; growth; preterm; newborn

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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 Outcomes (1)

• Evaluation of nutritional absorption of infants in the study and control groups

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

Study Arms (2)

Experimental Group

EXPERIMENTAL

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.

Other: Giving breast milk to the newborn according to the circadian rhythm

Control Groups

EXPERIMENTAL

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.

Other: Usual care

Interventions

Giving breast milk to the newborn according to the circadian rhythm OTHER

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

Experimental Group

Usual care OTHER

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

Control Groups

Eligibility Criteria

• Age: 32 Weeks - 34 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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
• th-90th percentile curves according to the infant's gestational age. percentile (those with normal birth weight for gestational age: Appropriate for Gestational Age -AGA)

You may not qualify if:

• 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).
• 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

Sponsors & Collaborators

• Sakarya University: lead

Study Sites (1)

Karamanoğlu Mehmet Bey University

Karaman, Turkey (Türkiye)

RECRUITING

Related Publications (10)

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

  BACKGROUND

• 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.

  PMID: 32759654 BACKGROUND

• 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.

  PMID: 25174435 BACKGROUND

• 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.

  PMID: 31765240 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 3431112 BACKGROUND

• 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.

  PMID: 26222826 BACKGROUND

• 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.

  PMID: 30682836 BACKGROUND

• 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.

  PMID: 28202638 BACKGROUND

• 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.

  PMID: 30858473 BACKGROUND

MeSH Terms

Conditions

Breast Feeding; Breast Milk Expression; Premature Birth

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Nejla Canbulat Şahiner, Prof.Dr.

  Karamanoğlu Mehmet Bey University

  STUDY DIRECTOR

• Ayşe Sonay Türkmen, Prof. Dr.

  Karamanoğlu Mehmet Bey University

  PRINCIPAL INVESTIGATOR

• Dilek Menekşe, Asst. prof.

  Sakarya University

  PRINCIPAL INVESTIGATOR

• Hacer Sibel Karapınar, Assoc. Prof.

  Karamanoğlu Mehmet Bey University

  PRINCIPAL INVESTIGATOR

• Murat Konak, Assoc. Prof.

  Selcuk University

  PRINCIPAL INVESTIGATOR

• Havvanur Bayam, Nutritionist

  Selcuk University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nejla Canbulat Şahiner, Prof.Dr.

CONTACT

+90 (338) 226 20 00; ncanbulat@kmu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single (participant) blinding was used in the study. For this purpose, it was not stated which group the participating mothers were in the research, but they were informed about the procedure to be performed. Therefore, a separate informed consent form was prepared for each group. Statistician blinding will also be applied. While coding the research data, the research group will be coded as A and B, and the statistician will be prevented from knowing which letter represents which group.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: January 20, 2024
• First Posted: April 2, 2024
• Study Start: January 25, 2024
• Primary Completion: April 1, 2025
• Study Completion: July 31, 2025
• Last Updated: May 1, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)