Breast FeedingNCT05846828
Cognitive Functions in Breastfed Preschool Children
An observational study of Breast Feeding, run by Assiut University.
Trial summary
The current work aims to assess of the cognitive development in breastefed children and compare it with artificially fed children as well as the duration of breastfeeding. Read more about this study
- Who is it for?
- Ages 3 to 5 years
- Conditions the study is for
- Breast Feeding
- What is being tested?
- Stanford Binet IQ test
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 1 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 5 years
- All sexes
- Child
Study population: preschool children aged from 3 to 5 years
Who may be able to join
- Children more than 3 years and till age of 5 years that present to Assiut University Hospital with acute diseases.
Who cannot join
- Children known to have chronic disease.
- Chidren with History of birth anoxia, birth trauma, kernictrus, epilepsy, metabolic diseases.
- Positive family history of mental retardation.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Assesment of Cognitive Functions in Breastfed Preschool Children In Assiut Governorate, Egypt
The current work aims to assess of the cognitive development in breastefed children and compare it with artificially fed children as well as the duration of breastfeeding.
Read the detailed description
Breastfeeding provides nutritional and immunological benefits to infants and also prevents infections . Breastfeeding also has clear short-term benefits for child survival through reduction of morbidity and mortality from infectious diseases. Breastfeeding also has longterm benefits .Breastfeeding improves cognitive development and emotional interactions between the mother and infant .A previous meta-analysis of 20 studies that compared breastfeeding with formula-feeding reported that breastfeeding is associated with significantly improved cognitive development from infancy to adolescence .The results of a meta-analysis of these studies showed that breastfeeding was associated with an increase of 3•5 points (95% CI 1•9-5•0) on intelligence tests at childhood and adolescence. This beneficial effect of breastfeeding could be due to the presence of long-chain polyunsaturated fatty acids, such as arachidonic acid and docosahexaenoic acid in breast milk . Breastfed infants have higher concentrations of these fatty acids that are positively associated with brain development .
Child cognitive development is influenced by genetic and environmental factors . The child has a genetically determined potential for cognitive development. However environmental factors, such as adequate nutrition and the parents' ability to create a good and stimulating home environment may also have a positive influence on the child's cognitive development .Several studies have shown a positive correlation between breast feeding and cognitive development in children . In this study we measure the mental development of children by the use of Stanford binet intelligence test. It is a cognitive and intelligence test that is used diagnose developmental and intellectual deficiencies in young children .
Other risk factors affecting children's mental development should be taken in consideration like the mothers' age, educational level (lower than high school, high school diploma, college degree, university degree, and higher than a university degree), family income, job status (employed/unemployed), sex of infant, gestational age, and infant birth weight.
- Conditions
- Breast Feeding
- Being tested
- Stanford Binet IQ test
- Keywords
- cognitive functions, IQ, Stanford binet test
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stanford Binet IQ testOther
The Fourth Edition Stanford-Binet test which is based upon a four-factor model of intelligence, and its 15 subtests are partitioned into :
- Verbal ability.
- Abstract/Visual ability.
- Quantaitive potential.
- Short-Term Memory Scales
What is being measured
The primary outcome is the main question the study is designed to answer.
assess the cognitive development in breastefed children by the use of Stanford binet intelligence test and compare it with artificially fed children as well as the duration of breastfeeding.
In this study we measure the mental development of breast fed and artificailly fed preschool children by the use of Stanford binet intelligence test to prove that breastfed children have higher IQ than artificially fed chidren
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start1 Sep 2023 (estimated)
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast FeedingStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Romany Eissa Atya Eissa, Assiut University
- Investigators
- Emad EL-Deen Mahmoud Hammad, prof, Principal investigator, Assiut UniversityAmr Mohamed Kotb, lecturer, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05846828
- Sponsor's protocol ID
- breastfeeding and IQ
- Status last verified
- Jul 2023
- First submitted
- 31 Mar 2023
- Last updated
- 19 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Golding J, Rogers IS, Emmett PM. Association between breast feeding, child development and behaviour. Early Hum Dev. 1997 Oct 29;49 Suppl:S175-84. doi: 10.1016/s0378-3782(97)00062-5.
PubMed 9363425Fergusson DM, Beautrais AL, Silva PA. Breast-feeding and cognitive development in the first seven years of life. Soc Sci Med. 1982;16(19):1705-8. doi: 10.1016/0277-9536(82)90096-x.
PubMed 7178917Lee H, Park H, Ha E, Hong YC, Ha M, Park H, Kim BN, Lee B, Lee SJ, Lee KY, Kim JH, Jeong KS, Kim Y. Effect of Breastfeeding Duration on Cognitive Development in Infants: 3-Year Follow-up Study. J Korean Med Sci. 2016 Apr;31(4):579-84. doi: 10.3346/jkms.2016.31.4.579. Epub 2016 Feb 22.
PubMed 27051242
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assesment of Cognitive Functions in Breastfed Preschool Children In Assiut Governorate, Egypt
- ClinicalTrials.gov ID
- NCT05846828
- Acronym / sponsor ID
- breastfeeding and IQ
- Conditions
- Breast Feeding
- Keywords
- cognitive functions, IQ, Stanford binet test
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current work aims to assess of the cognitive development in breastefed children and compare it with artificially fed children as well as the duration of breastfeeding.
Detailed description
Breastfeeding provides nutritional and immunological benefits to infants and also prevents infections . Breastfeeding also has clear short-term benefits for child survival through reduction of morbidity and mortality from infectious diseases. Breastfeeding also has longterm benefits .Breastfeeding improves cognitive development and emotional interactions between the mother and infant .A previous meta-analysis of 20 studies that compared breastfeeding with formula-feeding reported that breastfeeding is associated with significantly improved cognitive development from infancy to adolescence .The results of a meta-analysis of these studies showed that breastfeeding was associated with an increase of 3•5 points (95% CI 1•9-5•0) on intelligence tests at childhood and adolescence. This beneficial effect of breastfeeding could be due to the presence of long-chain polyunsaturated fatty acids, such as arachidonic acid and docosahexaenoic acid in breast milk . Breastfed infants have higher concentrations of these fatty acids that are positively associated with brain development .
Child cognitive development is influenced by genetic and environmental factors . The child has a genetically determined potential for cognitive development. However environmental factors, such as adequate nutrition and the parents' ability to create a good and stimulating home environment may also have a positive influence on the child's cognitive development .Several studies have shown a positive correlation between breast feeding and cognitive development in children . In this study we measure the mental development of children by the use of Stanford binet intelligence test. It is a cognitive and intelligence test that is used diagnose developmental and intellectual deficiencies in young children .
Other risk factors affecting children's mental development should be taken in consideration like the mothers' age, educational level (lower than high school, high school diploma, college degree, university degree, and higher than a university degree), family income, job status (employed/unemployed), sex of infant, gestational age, and infant birth weight.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Age groups
- Child
- Study population
- preschool children aged from 3 to 5 years
Key inclusion criteria (1 listed)
- Children more than 3 years and till age of 5 years that present to Assiut University Hospital with acute diseases.
Key exclusion criteria (3 listed)
- Children known to have chronic disease.
- Chidren with History of birth anoxia, birth trauma, kernictrus, epilepsy, metabolic diseases.
- Positive family history of mental retardation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stanford Binet IQ testThe Fourth Edition Stanford-Binet test which is based upon a four-factor model of intelligence, and its 15 subtests are partitioned into : 1. Verbal ability. 2. Abstract/Visual ability. 3. Quantaitive potential. 4. Short-Term Memory Scales | Other | – |
Primary outcome
assess the cognitive development in breastefed children by the use of Stanford binet intelligence test and compare it with artificially fed children as well as the duration of breastfeeding.
Time frame: Baseline
In this study we measure the mental development of breast fed and artificailly fed preschool children by the use of Stanford binet intelligence test to prove that breastfed children have higher IQ than artificially fed chidren
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
- Background: PubMed 9363425Golding J, Rogers IS, Emmett PM. Association between breast feeding, child development and behaviour. Early Hum Dev. 1997 Oct 29;49 Suppl:S175-84. doi: 10.1016/s0378-3782(97)00062-5.
- Background: PubMed 7178917Fergusson DM, Beautrais AL, Silva PA. Breast-feeding and cognitive development in the first seven years of life. Soc Sci Med. 1982;16(19):1705-8. doi: 10.1016/0277-9536(82)90096-x.
- Background: PubMed 27051242Lee H, Park H, Ha E, Hong YC, Ha M, Park H, Kim BN, Lee B, Lee SJ, Lee KY, Kim JH, Jeong KS, Kim Y. Effect of Breastfeeding Duration on Cognitive Development in Infants: 3-Year Follow-up Study. J Korean Med Sci. 2016 Apr;31(4):579-84. doi: 10.3346/jkms.2016.31.4.579. Epub 2016 Feb 22.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emad EL-Deen Mahmoud Hammad, prof principal investigator
Assiut University
Amr Mohamed Kotb, lecturer principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Feeding, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Romany Eissa Atya (01221695657, romany.eissa@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assess the cognitive development in breastefed children by the use of Stanford binet intelligence test and compare it with artificially fed children as well as the duration of breastfeeding. (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05846828, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2023.