ClinicalTrials.gg
Status unknownNCT03337893Updated Nov 9, 2017

Investigation of Breastfeeding Protection Against Infant Infections and Childhood Diseases

An observational study in Breast Feeding and Disease, sponsored by Yildiz Atadag. Status unknown at 1 site in Turkey. Open to participants aged 5 Years to 5 Years. Per ClinicalTrials.gov, last updated 2017-11-09.

Sponsored by Yildiz Atadag · Observational

The sponsor has not verified this record recently (last verified Nov 2017), so the status shown — last known as Enrolling by invitation — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
5 Years to 5 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 274 studies in Breast Feeding with a site in Turkey — 68 open to participants now, 77 under way, none of them phase 3. Breast Feeding · Turkey.

Planned enrollment
2nd of 22
500 · median 163
Started
2017
with 4 others
Observational
22 of 274
3 open now
Registered
3rd of 274
by date

Among the 274 studies in Breast Feeding with a site in Turkey, this one is the 2nd largest by planned enrollment of the 22 observational ones, is one of 5 that started in 2017, is one of 22 observational ones, and was the 3rd registered.

By phase

274 studies; the count open now beside each. This study's row is marked.

No phase251 · 65 open
Observationalthis study22 · 3 open
Phase 41 · 0 open

By the year they started

First in 2011; this study’s year is marked. 5 started in 2017.

What they test

Size and results

Median enrollment 80 across the 252 interventional studies, 163 across the 22 observational. Of the 178 that completed or were terminated, 0 (0%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 274 studies in Breast Feeding with a site in Turkey, or all of them as a file.
02

Study 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.

Read the 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.

03

Conditions studied

  • Breast Feeding
  • Disease
04

Who can participate

Ages eligible
5 Years to 5 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

5 year old kids

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Patient registry
No

Groups and cohorts

  • Breastfed

    The kids who breastfed

    Diagnostic Test: blood pressure

  • non-breastfed

    The kids who did not breastfed

    Diagnostic Test: blood pressure

Interventions

  • Diagnostic testblood pressure

    it will be done both right and left arms

06

What researchers measure

Primary outcomes

  1. BP

    Blood Pressure

    Time frame: Baseline for age 5

07

Study locations

1 site
  • Gaziantep Sahinbey Baglarbasi Family Health Center
    Gaziantep, Turkey
08

References and documents

Publications

  • Gökçay G, Garipağaoğlu M. Çocukluk ve Ergenlik Döneminde Beslenme. İstanbul: Saga Yayınları, 2002: 24-63.
  • Gökçay G, Garibağaoğlu M. Sağlıklı Çocuğun Beslenmesi. İçinde: Neyzi O, Ertuğrul T: Pediatri. 1. Cilt. İstanbul: Nobel Tıp Kitabevi, 2002: 183-202.
  • 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.
  • 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.
  • T.C. Sağlık Bakanlığı, Hacettepe Üniversitesi Nüfus Etüdleri Enstitüsü. Türkiye Nüfus ve Sağlık Araştırması 2003. Ankara: Macro International Inc, 2003.
  • 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
  • Stuebe A. The risks of not breastfeeding for mothers and infants. Rev Obstet Gynecol. 2009 Fall;2(4):222-31. PubMed 20111658 ↗
  • 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. PubMed 18065591 ↗
  • Mazıcıoğlu MM.Büyüme gelişme izleminde kullanılan antropometrik ölçüm yöntemleri: Büyüme takibinin metodolojisi.Türkiye Aile Hekimliği Dergisi 2011;15(3):101-108.
  • 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. PubMed 17625394 ↗
  • 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. PubMed 16410738 ↗
  • 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. PubMed 16702826 ↗
  • World Health Organization, UNICEF. Global Strategy for Infant and Young Child Feeding, Geneva: WHO, 2003: 1-4, 7-9.
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2017 (actual). Primary completion is estimated for Apr 2018, 6 months after the start.

Of 86 non-industry observational studies under Breast Feeding, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 54. This study's planned 6 months is below that.

Counting every sponsor, half of 96 studies reached it within 33 months; a quarter within 19 and three quarters within 73.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 23, 2017
First posted
Nov 9, 2017
StartActual
Oct 1, 2017
Primary completionEst.
Apr 1, 2018
CompletionEst.
Apr 1, 2018
Last update
Nov 9, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 9, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03337893
Lead sponsor
Yildiz Atadag
Responsible party
Yildiz Atadag (Medical Doctor, Umraniye Education and Research Hospital) — Sponsor-investigator
First posted
Nov 9, 2017
Start date
Oct 1, 2017
Primary completion
Apr 1, 2018 (estimated)
Completion
Apr 1, 2018 (estimated)
Last update
Nov 9, 2017

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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