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RECRUITING

NCT06342674

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

Sponsor: Sakarya University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

32 Weeks - 34 Weeks

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-01-25

Completion Date

2025-07-31

Last Updated

2024-05-01

Healthy Volunteers

Yes

Conditions

Breast Feeding Breast Milk Collection

Interventions

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

OTHER

Usual care

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

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

Locations (1)

Karamanoğlu Mehmet Bey University

Karaman, Turkey (Türkiye)