Patterns of Complementary Feeding in Infancy

January 9, 2018 updated by: Ahmed maher, Assiut University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 2 years (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  1. Infants (Age < 2 years).
  2. Full Term and Appropriate for Gestational Age (AGA).
  3. Infants with successful breastfeeding.

Exclusion Criteria:

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.

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: Case-Only
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
16 months
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
16 months
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
16 months
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
16 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Hanaa M Abdellatif, professor, Assuit University- pediatric hospital
  • Study Director: Osama M Al-asheer, professor, Assuit University - pediatric hospital
  • Principal Investigator: Ahmed M Abdullah, resident, Assuit University - pediatric hospital

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

Helpful Links

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 (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 27, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 2, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 10, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Complementary feeding

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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