Investigation of the Effect of Mother's Nutrition Status on Breast Milk Contents

Descriptive, Observational, Investigation of the Effect of Mother's Nutrition Status on Breast Milk Contents

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

Study Overview

• Status: Unknown
• Conditions: Breast Feeding
• Intervention / Treatment: Device: milk analyzer; Behavioral: Mother's nutrition values

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Mothers whose babies were followed in the neonatal follow-up outpatient clinic of the Neonatal Intensive Care Unit of Istanbul University Faculty of Medicine, Department of Pediatrics and Fifty will be composed of 50 mothers who meet the sample selection criteria.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Mother milk; Step 1: Mothers who meet the sample selection criteria will be informed about the scope of the study and their written and verbal consent will be obtained. Data collection form will be applied to mothers who accept to participate in the study by using face to face interview technique. Mothers and newborns will be weighed and 4 ml breast milk sample will be taken from the mother for manual milking.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Human Milk Macro Nutrients	CHA,Protein, Fat	15 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mother's Diet	BMI	24 hours

Collaborators and Investigators

• Sponsor: Halic University
• Collaborators: Istanbul University - Cerrahpasa (IUC)
• Investigators: Study Director: Gulçin Bozkurt, Assc. Prof., Istanvbul University-Cerrahpasa; Study Director: Asuman Çoban, Prof, Istanbul University

Publications and helpful links

General Publications

• 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):1231. doi: 10.3390/nu10091231.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): November 10, 2019
• Primary Completion (Anticipated): February 12, 2020
• Study Completion (Anticipated): May 12, 2020

Study Registration Dates

• First Submitted: November 4, 2019
• First Submitted That Met QC Criteria: November 8, 2019
• First Posted (Actual): November 12, 2019

Study Record Updates

• Last Update Posted (Actual): November 12, 2019
• Last Update Submitted That Met QC Criteria: November 8, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: SuleTez

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

IPD Plan Description

The population of the study will be composed of mothers whose babies are followed in the neonatal follow-up outpatient clinic of the Neonatal Intensive Care Unit of Istanbul University Faculty of Medicine, Department of Child Health and Diseases.

data collection form total of 69 questions; women's socio-demographic characteristics11 questions, baby's characteristics and nutrition10 questions, obstetric characteristics of pregnancy, curettage, abortion, childbirth 11 obstetric questions, features related to breastfeeding 8 questions, the mother's feeding habits 5 questions and 24 questions about the results of the mother's milk sample It is a daily (last 24 hours) form of food consumption which is required to indicate the foods consumed in the last 24 hours before. Data collection tools will be applied using face to face interview technique.

• IPD Sharing Time Frame: 8 mounts
• IPD Sharing Access Criteria: One year
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No