Investigation of Breastfeeding Protection Against Infant Infections and Childhood Diseases

November 6, 2017 updated by: Yildiz Atadag

Objective: It is widely accepted that breastfeeding (AS) is superior to other forms of nutrition in the first six months of life. Breastmilk contains nutrient items in appropriate quantities and a high bioavailability according to the needs of each baby. The United Nations Children's Fund (UNICEF) and the World Health Organization (WHO) recommend that babies take AS alone and then continue to feed on AS with up to two years of age, with appropriate supplementary nutrition, during the first six months of life.

Even in the hottest climates, breastfeeding babies have been shown to have no additional nutrient or fluid requirements for the first six months, including water. In the first 6 months of breastfeeding with breast milk alone (YAS), the incidence of many diseases, especially infectious diseases, decreases and the brain development is better.

Despite its numerous benefits, mother milk is not utilized in our country sufficiently. According to the Turkish Demographic and Health Survey (TNSA), the rate of breastfeeding in Turkey was 91.8% in Turkey, while the proportion of babies fed only breast milk in the first 6 months was 30.1%.

Infants related deaths, otitis media, lower respiratory tract infections, gastroenteritis, obesity were more common in children who were fed formula milk compared to children who were fed breast milk during the first year of life. Obesity can reduce insulin resistance and hypertension risks later in life.

According to the research done by Kramer and his colleagues on 13889 children, no effect of breastfeeding on physical development, obesity and hypertension was found.

In this study, whether breast feeding was associated with otitis media in the first year, lower respiratory tract infection, gastroenteritis; in the first 5 years of age, obesity and hypertension.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Method: This descriptive study will be conducted by Gaziantep Şahinbey Bağlarbaşı ASM, a 5-year-old children who applied between 01.10.2017 - 04.04.2018, with their weight and blood pressure measurements and their parents' questionnaires. Approximately 500 children will be taken to work. Informed consent is obtained from the parents of the patients who will be employed, and verbal consent is given from the children. Those who do not give their approval will not be included in the study. People with a known congenital disease, those with no birth week between 38 and 42 and a birth weight between 2500 and 4000 grams will not be included in the study.

The length measurement shall be made on a fixed scale, with the back of the head on a flat surface, with the head perpendicular, and with the eyes vertically facing (Frankfurt plane), the distance between the top of the head and the soles of the feet shall be a fixed scale or gauge. Blood pressure measurement will be measured by a digital blood pressure meter from the left and right hand (M6; Omron Healthcare).

Measurements of height, weight and hemoglobin in the past ages of the subjects taken in the study group will be taken from the computer programs used in the family medicine system. Percentile values of measurements belonging to each age group will also be recorded.

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Gaziantep, Turkey
        • Gaziantep Sahinbey Baglarbasi Family Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 5 years (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

5 year old kids

Description

Inclusion Criteria:

  • Being at the age of 5
  • birth weight between 2500 and 4000 grams
  • birth week is between 38-42 weeks

Exclusion Criteria:

  • Not being at the age of 5
  • birth week is not between 38-42 weeks
  • birth weight between 2500 and 4000 grams
  • having a serious illness e.g. cerebral palsy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Breastfed
The kids who breastfed
it will be done both right and left arms
non-breastfed
The kids who did not breastfed
it will be done both right and left arms

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BP
Time Frame: Baseline for age 5
Blood Pressure
Baseline for age 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2017

Primary Completion (Anticipated)

April 1, 2018

Study Completion (Anticipated)

April 1, 2018

Study Registration Dates

First Submitted

October 23, 2017

First Submitted That Met QC Criteria

November 6, 2017

First Posted (Actual)

November 9, 2017

Study Record Updates

Last Update Posted (Actual)

November 9, 2017

Last Update Submitted That Met QC Criteria

November 6, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 307

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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