Interdisciplinary Pharmaceutical Analysis: Artificial Milk Effects on Children and Postnatal Women's Health

NCT ID: NCT06653309

Last Updated: 2024-10-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2024-08-30

Brief Summary

Artificial milk, also known as infant formula, is a manufactured product designed to mimic the nutritional profile of human breast milk. Its biochemical composition is carefully crafted to provide a balanced mix of macronutrients, micronutrients, and other essential components that support the growth and development of infants . The primary macronutrients in artificial milk include carbohydrates, proteins, and fats, which are typically sourced from a combination of cow's milk, whey, and vegetable oils . Carbohydrates such as lactose and maltodextrins provide a quick source of energy, while proteins like whey protein and casein help to build and repair tissues. Fats like vegetable oils and medium-chain triglycerides (MCTs) provide essential fatty acids and help to support brain development .

In addition to these macronutrients, artificial milk also contains a range of micronutrients and other essential components that are important for infant health . These include vitamins like vitamin A, D, E, K, and C, as well as minerals like calcium, phosphorus, magnesium, and iron. Artificial milk may also contain added ingredients like DHA (docosahexaenoic acid) and ARA (arachidonic acid), which are important for brain and eye development . The exact composition of artificial milk can vary depending on the brand and type of formula, but most products are designed to meet the nutritional requirements established by organizations like the World Health Organization (WHO) and the American Academy of Pediatrics (AAP) . However, it is worth noting that the biochemical composition of artificial milk may not be identical to that of human breast milk, which is a complex mixture of nutrients and bioactive compounds that can provide unique benefits to infants .

Detailed Description

This study will employ a comparative observational design, involving a sample size of 200 children and their corresponding postnatal women. This design is a study in which the researcher is primary interested in describing relationships among variables, without seeking to establish a causal connection will utilize to conduct this study . The sample will be divided into two groups: a natural breastfeeding group and an artificial milk feeding group.

Conditions

Breast Feeding

Study Design

• Observational Model Type: FAMILY_BASED
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

a natural breastfeeding and their corresponding postnatal women group

100 a natural breastfeeding children, aged from 1 month to 1 year, and their corresponding postnatal women .

No interventions assigned to this group

artificial milk feeding group and their corresponding postnatal women group

100 children, aged from 1 month to 1 year, and their corresponding postnatal women . children in this group is depending on artificial milk consumption .

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Children aged between 1 month and 1 year.
• Postnatal women who have given birth to a healthy neonate
• Postnatal women who are willing to participate in the study

Exclusion Criteria

• • Children with major congenital anomalies or genetic disorders

• Postnatal women with a history of breast surgery or trauma that may affect lactation
• Postnatal women with a history of lactation insufficiency or nipple soreness

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 1 Year
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Delta University for Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Basma Wageah Mohamed Mohamed Elrefay

Lecturer of obstetrics and gynaecology Nursing, Faculty of nursing- Delta University for Science and Technology, Egypt

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Basma Wageah Mohamed Mohamed Elrefay

Al Manşūrah, Al Dakahlya, Egypt

Countries

Egypt

Other Identifiers

Artificial Milk postnatal

Identifier Type: -

Identifier Source: org_study_id