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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04158999
Other study ID # SuleTez
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date November 10, 2019
Est. completion date May 12, 2020

Study information

Verified date November 2019
Source Halic University
Contact Fatma Sule Tanriverdi, MsC Student
Phone 05413606482
Email sulebilgicc@outlook.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

This study; this work; The aim is to investigate the effects of mothers' nutritional status on breast milk macro nutrients (carbohydrate, fat and protein).


Description:

Macronutrients in breast milk can be affected by various factors. The mothers will be taken in the first 24 hours after birth and their nutritional habits, socio-demographic characteristics, anthropometric characteristics of the mother, body mass index will be examined and newborn characteristics will be taken. 2 ml sample from colostrum will be analyzed with milk analyzer instrument. The mothers will be re-checked on the 5th day and their anthropometric properties will be obtained. The same procedure will be repeated on the 15th day after childbirth. At each control, the mother's last 24-hour feeding status will be taken and the nutritional values consumed by "BeBis" program will be examined.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date May 12, 2020
Est. primary completion date February 12, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

- Follow-up of the infant in the Neonatal Intensive Care Unit, Istanbul Faculty of Medicine, Department of Pediatrics,

- The mother is able to understand and answer the questions,

- Single pregnancy,

- The baby's birth week is 34 weeks or more,

- The mother does not have a disease (Diabetes, hypertension, hypothyroidism, etc.) that may affect breast milk content.

Exclusion Criteria:

- Multiple pregnancy,

- The birth week of the baby is less than 34 weeks.

- Breastfeeding or breast problems in the mother,

- The mother has a disease that may affect breast milk content (Diabetes, hypertension, hypothyroidism, etc.),

- The mother is not willing to participate in the research,

- A disease known to be transmitted by breast milk (HIV, hepatitis B, hepatitis C, etc.).

Study Design


Related Conditions & MeSH terms


Intervention

Device:
milk analyzer
Human Milk Sample
Behavioral:
Mother's nutrition values
evaluation of nutritional elements of maternal onset with Bebis Program

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Halic University Istanbul University-Cerrahpasa

References & Publications (2)

Bravi F, Wiens F, Decarli A, Dal Pont A, Agostoni C, Ferraroni M. Impact of maternal nutrition on breast-milk composition: a systematic review. Am J Clin Nutr. 2016 Sep;104(3):646-62. doi: 10.3945/ajcn.115.120881. Epub 2016 Aug 17. Review. — View Citation

Butts CA, Hedderley DI, Herath TD, Paturi G, Glyn-Jones S, Wiens F, Stahl B, Gopal P. Human Milk Composition and Dietary Intakes of Breastfeeding Women of Different Ethnicity from the Manawatu-Wanganui Region of New Zealand. Nutrients. 2018 Sep 4;10(9). pii: E1231. doi: 10.3390/nu10091231. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Human Milk Macro Nutrients CHA,Protein, Fat 15 Days
Secondary Mother's Diet BMI 24 hours
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