Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06342674
Status:
RECRUITING
Last Update Posted:
2024-05-01
First Post:
2024-01-20
Brief Title:
Effect of Breast Milk Circadian Properties on Infants Growth Parameters and Absorption of Nutrients
Sponsor:
Sakarya University
Organization:
Sakarya University
Study Overview
Official Title:
Effect of Breast Milk Circadian Properties on Infant Growth Parameters and Nutrient Absorption in Preterm Newborns
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
The
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 infants 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 infants 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 infants 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
no effect on the infants 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
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 babys 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 mothers 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 changeIt 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 parentsenvironment This situation may negatively affect the babys 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
Breast milk contains many complex nutrients and while the amount of some nutrients varies depending on the mothers 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 changeIt 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 parentsenvironment This situation may negatively affect the babys 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None