Clinical trial NCT03206424: Patterns of Complementary Feeding in Infancy
Official title: Pattern of Complementary Feeding and Its Impact on Growth Parameters of Infants Under the Age of 2 Years in Assiut Governorate
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Complementary Feeding
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-07-02
Enrollment: 1000
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

Brief 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 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.

Eligibility criteria: 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.

Primary outcomes:
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.
timeFrame: 16 months
measure: Growth parameters
timeFrame: 16 months
measure: Motor development parameters
timeFrame: 16 months
measure: Mental development parameters
timeFrame: 16 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assuit University- pediatric hospital
name: Hanaa M Abdellatif, professor
role: STUDY_CHAIR
affiliation: Assuit University - pediatric hospital
name: Osama M Al-asheer, professor
role: STUDY_DIRECTOR
affiliation: Assuit University - pediatric hospital
name: Ahmed M Abdullah, resident
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Batal 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.
citation: WHO 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.
citation: Davies-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.