Clinical trial NCT06653309: Interdisciplinary Pharmaceutical Analysis: Artificial Milk Effects on Children and Postnatal Women's Health
Official title: Interdisciplinary Pharmaceutical Analysis: Artificial Milk Effects on Neonates and Postnatal Women's Health
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Feeding
Keywords: Postnatal - Artificial Milk
Lead sponsor: Delta University for Science and Technology
Sponsor class: OTHER
First posted: 2024-10-22
Enrollment: 200
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 200 children, aged from 1 month to 1 year, and their corresponding postnatal women will provide sufficient power to detect statistically significant differences between the two groups, with a minimum of 100 participants in each group. Sample size was calculated using Open Epi I program at confidence interval 95% and power of 80%.

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.

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

Primary outcomes:
measure: increase global awareness about assessments of breast feeding and its difficulties
timeFrame: 3 months
Secondary outcomes:
measure: raising awareness about the burden of depressive symptoms many women experience in postnatal women care
timeFrame: 3 months
Other outcomes:
Locations:
city: Al Manşūrah
country: Egypt
facility: Basma Wageah Mohamed Mohamed Elrefay
state: Al Dakahlya
Study officials:
References: