Ignite Creation Date:
2024-05-06 @ 7:14 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05943847
Status:
RECRUITING
Last Update Posted:
2023-08-08
First Post:
2023-04-11
Brief Title:
Neurotrophic Growth Factors in Breast Milk
Sponsor:
Istanbul University
Organization:
Istanbul University
Study Overview
Official Title:
Evaluation of Neurotrophic Growth Factors in Breast Milk at Two Years of Age and Beyond
Status:
RECRUITING
Status Verified Date:
2023-08
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:
None
Brief Summary:
The goal of this observational study is to demonstrate the presence of neurotrophic factors in the breast milk of mothers with 18-month-old children and the persistence of these factors in breast milk after the age of 2 years The main questions it aims to answer are
Does the breast milk of mothers with 18-month-old babies contain Brain-Derived Neurotrophic Factor BDNF S100B protein and glial cell line-derived neurotrophic factor GDNF
Does the breast milk continue to contain BDNF s100B protein and GDNF and-after 24 months
Participants will be asked to give breastmilk at 3 separate times Breast milk samples will be collected from mothers at 18th-month 24th-month and 25 months of their babies A total of 75 breast milk samples obtained from 25 mothers with their consent will be analyzed
Does the breast milk of mothers with 18-month-old babies contain Brain-Derived Neurotrophic Factor BDNF S100B protein and glial cell line-derived neurotrophic factor GDNF
Does the breast milk continue to contain BDNF s100B protein and GDNF and-after 24 months
Participants will be asked to give breastmilk at 3 separate times Breast milk samples will be collected from mothers at 18th-month 24th-month and 25 months of their babies A total of 75 breast milk samples obtained from 25 mothers with their consent will be analyzed
Detailed Description:
Growth factors are among the bioactive compounds found in breast milk and have effects on the growth and maturation of the babys organs and systems The completion of each organ maturation occurs at different times Although the development of the nervous system reaches 60 of adults at the age of 2 years it continues after the age of 2 Brain-Derived Neurotrophic Factor BDNF S100B protein and glial cell line-derived neurotrophic factor GDNF are the neurotrophic growth factors found in breast milk and play a critical role in the development of the nervous system the maintenance of neuronal functionality and the proliferation of neurons They play a role during brain development particularly in differentiating neuronal and glial cells In addition it is effective in synaptic plasticity and has important roles in the mature nervous system The presence of neurotrophic factors in breast milk under the age of one has been demonstrated However the presence of these factors in breast milk has not been evaluated at 2 years and above In this study investigators aimed to demonstrate the presence of neurotrophic factors in the breast milk of mothers with 18-month-old children and the persistence of these factors in breast milk after the age of 2 years
Study Design
The study was conducted at Istanbul University Istanbul Medical Faculty Department of Pediatrics Department of Social Pediatrics Well Child Outpatient Clinic All mothers participating in the study are informed in detail about the study and the importance of breast milk According to Turkish Demographic and Health Survey TDHS 2018 data the rate of breastfeeding is 66 at 12 months 50 at 18 months and 34 at 24 months Considering the decrease according to age it was assumed that the breastfeeding rate would be 18 after the age of 2 Considering the TDHS 2018 data of mothers assuming that 18 of mothers breastfeed their babies after the age of 2 with a 95 confidence level and an acceptable sampling error of 015 the sample size calculation formula was used to estimate the population ratio and the sample size was calculated for each mother It is planned to have at least 25 mothers during the milk collection period for each mother 18 24 25 months with a total of 75 breast milk
Breast milk collections and analysis
1 Breast milk will be collected at 3 separate times at 18th-month 24th-month and 25 months of their babies
2 Using the manual milking method 5 ml of expressed breast milk will be collected in Eppendorf tubes and transported in a polystyrene box containing ice at 4C to the laboratory within 30 minutes All breast milk samples will be stored at -20C under laboratory conditions until the analysis
3 All collected breast milk samples will be prepared for analysis by gradual thawing breast milk will be taken to 4 C degrees one day before analysis room temperature on the day of analysis at the 12th month of the study The neurotrophic factors BDNF S100B GDNF will be analyzed with ELISA Elabsicence United States method
Study Design
The study was conducted at Istanbul University Istanbul Medical Faculty Department of Pediatrics Department of Social Pediatrics Well Child Outpatient Clinic All mothers participating in the study are informed in detail about the study and the importance of breast milk According to Turkish Demographic and Health Survey TDHS 2018 data the rate of breastfeeding is 66 at 12 months 50 at 18 months and 34 at 24 months Considering the decrease according to age it was assumed that the breastfeeding rate would be 18 after the age of 2 Considering the TDHS 2018 data of mothers assuming that 18 of mothers breastfeed their babies after the age of 2 with a 95 confidence level and an acceptable sampling error of 015 the sample size calculation formula was used to estimate the population ratio and the sample size was calculated for each mother It is planned to have at least 25 mothers during the milk collection period for each mother 18 24 25 months with a total of 75 breast milk
Breast milk collections and analysis
1 Breast milk will be collected at 3 separate times at 18th-month 24th-month and 25 months of their babies
2 Using the manual milking method 5 ml of expressed breast milk will be collected in Eppendorf tubes and transported in a polystyrene box containing ice at 4C to the laboratory within 30 minutes All breast milk samples will be stored at -20C under laboratory conditions until the analysis
3 All collected breast milk samples will be prepared for analysis by gradual thawing breast milk will be taken to 4 C degrees one day before analysis room temperature on the day of analysis at the 12th month of the study The neurotrophic factors BDNF S100B GDNF will be analyzed with ELISA Elabsicence United States method
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