Complementary FeedingNCT03206424
Patterns of Complementary Feeding in Infancy
An observational study of Complementary Feeding, run by Assiut University.
Trial summary
WHO and UNICEF recommend exclusive breastfeeding for six months and addition of complementary foods (CF) at six months of age with continued breastfeeding till two years But WHO estimates that 2 out of 5 children are stunted in low-income countries, so CF should be timely, adequate and prepared and given in a safe… Read more about this study
- Who is it for?
- Ages Up to 2 years
- Conditions the study is for
- Complementary Feeding
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2018to 30 Jun 2019
- 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 Up to 2 years
- All sexes
- Child
Study population: collecting data through face-to-face interviews with mothers in the health centers for good history and assessment of the infant growth and development.The index cases visiting our hospital and other local public health centers for various reasons such routine check-ups, vaccinations or illness are recruited in the study.
Who may be able to join
- Infants (Age < 2 years).
- Full Term and Appropriate for Gestational Age (AGA).
- Infants with successful breastfeeding.
Who cannot join
- 1-Children (Age> 2 years). 2. Preterm infants, Small for Gestational Age (SGA) or Intrauterine Growth Retardation (IUGR).
- 3. Infants with chronic illness, intrauterine infection and major congenital anomalies.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Pattern of Complementary Feeding and Its Impact on Growth Parameters of Infants Under the Age of 2 Years in Assiut Governorate
WHO and UNICEF recommend exclusive breastfeeding for six months and addition of complementary foods (CF) at six months of age with continued breastfeeding till two years But WHO estimates that 2 out of 5 children are stunted in low-income countries, so CF should be timely, adequate and prepared and given in a safe manner.
Read the detailed description
World Health Organization (WHO) and United Nations Children's Fund (UNICEF) recommend exclusive breastfeeding (EBF) for six months, i.e. 180 days and addition of complementary foods at six months of age with continued breastfeeding till at least two years.
When breast milk is no longer enough to meet the nutritional needs of the infant, complementary foods should be added to the diet of the child. The transition from exclusive breastfeeding to family foods, referred to as complementary feeding, typically covers the period from 6 to 18-24 months of age, and is a very vulnerable period.
It is the time when malnutrition starts in many infants, contributing significantly to the high prevalence of malnutrition in children less than five years of age world-wide. WHO estimates that 2 out of 5 children are stunted in low-income countries.
Complementary feeding should be timely, meaning that all infants should start receiving foods in addition to breast milk from 6 months onwards.
It should be adequate, meaning that the complementary foods should be given in amounts, frequency and consistency and using a variety of foods to cover the nutritional needs of the growing child while maintaining breastfeeding.
Foods should be prepared and given in a safe manner, meaning that measures are taken to minimize the risk of contamination with pathogens. And they should be given in a way that is appropriate, meaning that foods are of appropriate texture for the age of the child and applying responsive feeding following the principles of psycho-social care.
Breastfeeding is common in developing countries, but exclusive breastfeeding is rare, and complementary foods are introduced at an early age. Poorer nutritional status was significantly associated with earlier complementary feeding. The results suggest that exclusive breastfeeding, (together with promotion of weaning education and growth monitoring) should be vigorously promoted in these developing countries.
Child development experts advise parents not to introduce solid foods, such as baby cereal, into an infant's diet until the infant is at least 4 to 6 months old. The researchers also found that formula-fed infants were much more likely to be given solid foods too early than were breast-fed infants. Health authorities do advise parents to wait until after 4 months because infants aren't developmentally ready to eat solid foods before. There are a number of other reasons why experts don't recommend early feeding. One is that the early introduction of solid foods has been linked to a shorter duration of breast-feeding. Early solid food consumption has also been linked to the development of chronic conditions, such as childhood obesity, celiac disease, diabetes and eczema.
So that we will do this study in our government region to evaluate Complementary feeding practices and their impact on the health status of our infants, we will recruit a cross sectional sample from those who visit our hospital clinics for various reasons such routine check-ups, vaccinations or illness.
- Conditions
- Complementary Feeding
What is being measured
The primary outcome is the main question the study is designed to answer.
A questionnaire developed following the guidelines of WHO for CF practices, is used for collecting data through face-to-face interviews with mothers in the health centers.
Specific values taken by good history from mother of the index infant including:
- When and why did the mother start complementary feeding?
- What is the type of food?
- How much food taken in one meal and How many meals are taken within the day?
- How does she prepare and give this food?
- What the effect of this food on breastfeeding demand or frequency?
- Ask about incidence and frequency of problems related to beginning of complementary food such as attacks of Acute gastroenteritis, Constipation or Acute chest infection.
- Information about the index infant: name, age, sex, his/her order in the family, height and weight of child at birth.
- General information about the parents such as name, age, place of residence, educational level, occupational status, socioeconomic level, self-hygiene and number of children of the family.
Data will be processed and analyzed using ( Statistical Package for the Social Sciences ) software, version 17
Measured: 16 months
Growth parameters
- Weight for age percentile.
- Height / Length for age percentile.
- Weight for Height percentile.
- Head Circumference for age percentile.
Data will be processed and analyzed using ( Statistical Package for the Social Sciences ) software, version 17
Measured: 16 months
Motor development parameters
Motor development milestones will be measured according to the infant actual age:
- Head support.
- Sitting.
- Standing.
- Walking.
- Running.
Data will be processed and analyzed using ( Statistical Package for the Social Sciences ) software, version 17
Measured: 16 months
Mental development parameters
Mental development milestones will be measured according to the infant actual age:
- Follows moving objects and light.
- Laughs loudly and prefers social content.
- Recognizes and prefers mother.
- Says "Mama, Dada".
- Speaks first real word.
- Speaks 10-15 words.
- Speaks 2- 3 word sentences.
Data will be processed and analyzed using ( Statistical Package for the Social Sciences ) software, version 17
Measured: 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start1 Feb 2018 (estimated)
- Primary completion30 Jun 2019 (estimated)
- Study completion30 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Complementary 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed maher, Assiut University
- Investigators
- Hanaa M Abdellatif, professor, Study chair, Assuit University- pediatric hospitalOsama M Al-asheer, professor, Study director, Assuit University - pediatric hospitalAhmed M Abdullah, resident, Principal investigator, Assuit University - pediatric hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03206424
- Sponsor's protocol ID
- Complementary feeding
- Status last verified
- Jan 2018
- First submitted
- 27 Jun 2017
- Last updated
- 10 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Saleh F, Ara F, Hoque MA, Alam MS. Complementary feeding practices among mothers in selected slums of Dhaka city: a descriptive study. J Health Popul Nutr. 2014 Mar;32(1):89-96.
PubMed 24847597Batal M, Boulghourjian C, Akik C. Complementary feeding patterns in a developing country: a cross-sectional study across Lebanon. East Mediterr Health J. 2010 Feb;16(2):180-6.
PubMed 20799572WHO Multicentre Growth Reference Study Group. Complementary feeding in the WHO Multicentre Growth Reference Study. Acta Paediatr Suppl. 2006 Apr;450:27-37. doi: 10.1111/j.1651-2227.2006.tb02373.x.
PubMed 16817676Davies-Adetugbo AA, Adetugbo K. Effect of early complementary feeding on nutritional status in term infants in rural Nigeria. Nutr Health. 1997;12(1):25-31. doi: 10.1177/026010609701200103.
PubMed 9403879
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pattern of Complementary Feeding and Its Impact on Growth Parameters of Infants Under the Age of 2 Years in Assiut Governorate
- ClinicalTrials.gov ID
- NCT03206424
- Acronym / sponsor ID
- Complementary feeding
- Conditions
- Complementary Feeding
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Feb 2018 (estimated)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 2 Jul 2017 (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.
WHO and UNICEF recommend exclusive breastfeeding for six months and addition of complementary foods (CF) at six months of age with continued breastfeeding till two years But WHO estimates that 2 out of 5 children are stunted in low-income countries, so CF should be timely, adequate and prepared and given in a safe manner.
Detailed description
World Health Organization (WHO) and United Nations Children's Fund (UNICEF) recommend exclusive breastfeeding (EBF) for six months, i.e. 180 days and addition of complementary foods at six months of age with continued breastfeeding till at least two years.
When breast milk is no longer enough to meet the nutritional needs of the infant, complementary foods should be added to the diet of the child. The transition from exclusive breastfeeding to family foods, referred to as complementary feeding, typically covers the period from 6 to 18-24 months of age, and is a very vulnerable period.
It is the time when malnutrition starts in many infants, contributing significantly to the high prevalence of malnutrition in children less than five years of age world-wide. WHO estimates that 2 out of 5 children are stunted in low-income countries.
Complementary feeding should be timely, meaning that all infants should start receiving foods in addition to breast milk from 6 months onwards.
It should be adequate, meaning that the complementary foods should be given in amounts, frequency and consistency and using a variety of foods to cover the nutritional needs of the growing child while maintaining breastfeeding.
Foods should be prepared and given in a safe manner, meaning that measures are taken to minimize the risk of contamination with pathogens. And they should be given in a way that is appropriate, meaning that foods are of appropriate texture for the age of the child and applying responsive feeding following the principles of psycho-social care.
Breastfeeding is common in developing countries, but exclusive breastfeeding is rare, and complementary foods are introduced at an early age. Poorer nutritional status was significantly associated with earlier complementary feeding. The results suggest that exclusive breastfeeding, (together with promotion of weaning education and growth monitoring) should be vigorously promoted in these developing countries.
Child development experts advise parents not to introduce solid foods, such as baby cereal, into an infant's diet until the infant is at least 4 to 6 months old. The researchers also found that formula-fed infants were much more likely to be given solid foods too early than were breast-fed infants. Health authorities do advise parents to wait until after 4 months because infants aren't developmentally ready to eat solid foods before. There are a number of other reasons why experts don't recommend early feeding. One is that the early introduction of solid foods has been linked to a shorter duration of breast-feeding. Early solid food consumption has also been linked to the development of chronic conditions, such as childhood obesity, celiac disease, diabetes and eczema.
So that we will do this study in our government region to evaluate Complementary feeding practices and their impact on the health status of our infants, we will recruit a cross sectional sample from those who visit our hospital clinics for various reasons such routine check-ups, vaccinations or illness.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Age groups
- Child
- Study population
- collecting data through face-to-face interviews with mothers in the health centers for good history and assessment of the infant growth and development.The index cases visiting our hospital and other local public health centers for various reasons such routine check-ups, vaccinations or illness are recruited in the study.
Key inclusion criteria (3 listed)
- Infants (Age < 2 years).
- Full Term and Appropriate for Gestational Age (AGA).
- Infants with successful breastfeeding.
Key exclusion criteria (2 listed)
- 1-Children (Age> 2 years). 2. Preterm infants, Small for Gestational Age (SGA) or Intrauterine Growth Retardation (IUGR).
- 3. Infants with chronic illness, intrauterine infection and major congenital anomalies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
A questionnaire developed following the guidelines of WHO for CF practices, is used for collecting data through face-to-face interviews with mothers in the health centers.
Time frame: 16 months
Specific values taken by good history from mother of the index infant including: 1. When and why did the mother start complementary feeding? 2. What is the type of food? 3. How much food taken in one meal and How many meals are taken within the day? 4. How does she prepare and give this food? 5. What the effect of this food on breastfeeding demand or frequency? 6. Ask about incidence and frequency of problems related to beginning of complementary food such as attacks of Acute gastroenteritis, Constipation or Acute chest infection. 7. Information about the index infant: name, age, sex, his/her order in the family, height and weight of child at birth. 8. General information about the parents such as name, age, place of residence, educational level, occupational status, socioeconomic level, self-hygiene and number of children of the family. Data will be processed and analyzed using ( Statistical Package for the Social Sciences ) software, version 17
Growth parameters
Time frame: 16 months
1. Weight for age percentile. 2. Height / Length for age percentile. 3. Weight for Height percentile. 4. Head Circumference for age percentile. Data will be processed and analyzed using ( Statistical Package for the Social Sciences ) software, version 17
Motor development parameters
Time frame: 16 months
Motor development milestones will be measured according to the infant actual age: 1. Head support. 2. Sitting. 3. Standing. 4. Walking. 5. Running. Data will be processed and analyzed using ( Statistical Package for the Social Sciences ) software, version 17
Mental development parameters
Time frame: 16 months
Mental development milestones will be measured according to the infant actual age: 1. Follows moving objects and light. 2. Laughs loudly and prefers social content. 3. Recognizes and prefers mother. 4. Says "Mama, Dada". 5. Speaks first real word. 6. Speaks 10-15 words. 7. Speaks 2- 3 word sentences. Data will be processed and analyzed using ( Statistical Package for the Social Sciences ) software, version 17
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2018.
- Results publication: PubMed 24847597Saleh F, Ara F, Hoque MA, Alam MS. Complementary feeding practices among mothers in selected slums of Dhaka city: a descriptive study. J Health Popul Nutr. 2014 Mar;32(1):89-96.
- Results publication: PubMed 20799572Batal M, Boulghourjian C, Akik C. Complementary feeding patterns in a developing country: a cross-sectional study across Lebanon. East Mediterr Health J. 2010 Feb;16(2):180-6.
- Results publication: PubMed 16817676WHO Multicentre Growth Reference Study Group. Complementary feeding in the WHO Multicentre Growth Reference Study. Acta Paediatr Suppl. 2006 Apr;450:27-37. doi: 10.1111/j.1651-2227.2006.tb02373.x.
- Results publication: PubMed 9403879Davies-Adetugbo AA, Adetugbo K. Effect of early complementary feeding on nutritional status in term infants in rural Nigeria. Nutr Health. 1997;12(1):25-31. doi: 10.1177/026010609701200103.
- Complementary feeding practices among mothers in selected slums of Dhaka city: a descriptive studyLink provided by the sponsor.
- Complementary feeding patterns in developing country: a cross-sectional study across LebanonLink provided by the sponsor.
- WHO Multicentre Growth Reference Study Group. Complementary feeding in the WHO Multicentre Growth Reference StudyLink provided by the sponsor.
- . Effect of early complementary feeding on nutritional status in term infants in rural Nigeria. Nutr HealthLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Hanaa M Abdellatif, professor study chair
Assuit University- pediatric hospital
Osama M Al-asheer, professor study director
Assuit University - pediatric hospital
Ahmed M Abdullah, resident principal investigator
Assuit University - pediatric hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Complementary 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 3 inclusion and 2 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 10 Jan 2018. 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 Ahmed maher, resident (0201118416586, www.Dr.clever25@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A questionnaire developed following the guidelines of WHO for CF practices, is used for collecting data through face-to-face interviews with mothers in the health centers. (time frame: 16 months). The study lists 4 primary outcomes in all. 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 NCT03206424, which also lists 4 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 10 Jan 2018.