NCT03337893

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2017

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

October 23, 2017

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 9, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

November 9, 2017

Status Verified

November 1, 2017

Enrollment Period

6 months

First QC Date

October 23, 2017

Last Update Submit

November 6, 2017

Conditions

Breast FeedingDisease

Outcome Measures

Primary Outcomes (1)

  • BP

    Blood Pressure

    Baseline for age 5

Study Arms (2)

Breastfed

The kids who breastfed

Diagnostic Test: blood pressure

non-breastfed

The kids who did not breastfed

Diagnostic Test: blood pressure

Interventions

blood pressureDIAGNOSTIC_TEST

it will be done both right and left arms

Breastfednon-breastfed

Eligibility Criteria

Age5 Years - 5 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

5 year old kids

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziantep Sahinbey Baglarbasi Family Health Center

Gaziantep, Turkey (Türkiye)

Location

Related Publications (13)

  • Gökçay G, Garipağaoğlu M. Çocukluk ve Ergenlik Döneminde Beslenme. İstanbul: Saga Yayınları, 2002: 24-63.

    BACKGROUND

  • Gökçay G, Garibağaoğlu M. Sağlıklı Çocuğun Beslenmesi. İçinde: Neyzi O, Ertuğrul T: Pediatri. 1. Cilt. İstanbul: Nobel Tıp Kitabevi, 2002: 183-202.

    BACKGROUND

  • American Academy of Pediatrics. Nutrition and Immunitiy. Chapter 31. In: Pediatric Nutriton Handbook CD- ROM. 4 th ed. Elk Growe Village: Abbott Laboratories, 1998: 473-84.

    BACKGROUND

  • Lawrens RA, Lawrence RM. Host-resistance factors and immunologic significance of human milk. In: Lawrens RA, Lawrence RM (eds). Breastfeeding. St. Louis: Mosby, 1994: 159-95.

    BACKGROUND

  • T.C. Sağlık Bakanlığı, Hacettepe Üniversitesi Nüfus Etüdleri Enstitüsü. Türkiye Nüfus ve Sağlık Araştırması 2003. Ankara: Macro International Inc, 2003.

    BACKGROUND

  • Hacettepe Üniversitesi Nüfus Etütleri Enstitüsü (2014), "2013 Türkiye Nüfus ve Sağlık Araştırması". Hacettepe Üniversitesi Nüfus Etütleri Enstitüsü, T.C. Kalkınma Bakanlığı ve TÜBİTAK, Ankara, Türkiye

    BACKGROUND

  • Stuebe A. The risks of not breastfeeding for mothers and infants. Rev Obstet Gynecol. 2009 Fall;2(4):222-31.

    PMID: 20111658BACKGROUND

  • Kramer MS, Matush L, Vanilovich I, Platt RW, Bogdanovich N, Sevkovskaya Z, Dzikovich I, Shishko G, Collet JP, Martin RM, Davey Smith G, Gillman MW, Chalmers B, Hodnett E, Shapiro S; PROBIT Study Group. Effects of prolonged and exclusive breastfeeding on child height, weight, adiposity, and blood pressure at age 6.5 y: evidence from a large randomized trial. Am J Clin Nutr. 2007 Dec;86(6):1717-21. doi: 10.1093/ajcn/86.5.1717.

    PMID: 18065591BACKGROUND

  • Mazıcıoğlu MM.Büyüme gelişme izleminde kullanılan antropometrik ölçüm yöntemleri: Büyüme takibinin metodolojisi.Türkiye Aile Hekimliği Dergisi 2011;15(3):101-108.

    BACKGROUND

  • Altunkan S, Ilman N, Kayaturk N, Altunkan E. Validation of the Omron M6 (HEM-7001-E) upper-arm blood pressure measuring device according to the International Protocol in adults and obese adults. Blood Press Monit. 2007 Aug;12(4):219-25. doi: 10.1097/MBP.0b013e3280f813d0.

    PMID: 17625394BACKGROUND

  • Coleman A, Freeman P, Steel S, Shennan A. Validation of the Omron 705IT (HEM-759-E) oscillometric blood pressure monitoring device according to the British Hypertension Society protocol. Blood Press Monit. 2006 Feb;11(1):27-32. doi: 10.1097/01.mbp.0000189788.05736.5f.

    PMID: 16410738BACKGROUND

  • Topouchian JA, El Assaad MA, Orobinskaia LV, El Feghali RN, Asmar RG. Validation of two automatic devices for self-measurement of blood pressure according to the International Protocol of the European Society of Hypertension: the Omron M6 (HEM-7001-E) and the Omron R7 (HEM 637-IT). Blood Press Monit. 2006 Jun;11(3):165-71. doi: 10.1097/01.mbp.0000209078.17246.34.

    PMID: 16702826BACKGROUND

  • World Health Organization, UNICEF. Global Strategy for Infant and Young Child Feeding, Geneva: WHO, 2003: 1-4, 7-9.

    BACKGROUND

MeSH Terms

Conditions

Breast FeedingDisease

Interventions

Blood Pressure

Condition Hierarchy (Ancestors)

Feeding BehaviorBehaviorPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vital SignsPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisHemodynamicsCardiovascular Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

October 23, 2017

First Posted

November 9, 2017

Study Start

October 1, 2017

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

November 9, 2017

Record last verified: 2017-11

Locations

TU(1)