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

NCT06653309 | Completed

• 1 other identifier: Artificial Milk postnatal
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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 .

Conditions

Breast Feeding

Keywords

Postnatal - Artificial Milk

Outcome Measures

Primary Outcomes (1)

• increase global awareness about assessments of breast feeding and its difficulties

  Nurses most often use a subjective "well/fair/poor" system to assess and document breastfeeding. LATCH is a breastfeeding charting system that provides a systematic method for gathering information about individual breastfeeding sessions. The system assigns a numerical score, 0, 1, or 2, to five key components of breastfeeding. Each letter of the acronym LATCH denotes an area of assessment. "L" is for how well the infant latches onto the breast. "A" is for the amount of audible swallowing noted. "T" is for the mother's nipple type. "C" is for the mother's level of comfort. "H" is for the amount of help the mother needs to hold her infant to the breast. The system is visually represented in the same form as the Apgar scoring grid, and the numbers are handled in the same way. With the LA TCH system, the nurse can assess maternal and infant variables, define areas of needed intervention, and determine priorities in providing patient care and teaching

  3 months

Secondary Outcomes (1)

• raising awareness about the burden of depressive symptoms many women experience in postnatal women care

  3 months

Study Arms (2)

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 .

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 .

Eligibility Criteria

• Age: 1 Month - 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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%.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Delta University for Science and Technology: lead

Study Sites (1)

Basma Wageah Mohamed Mohamed Elrefay

Al Manşūrah, Al Dakahlya, 35111, Egypt

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of obstetrics and gynaecology Nursing, Faculty of nursing- Delta University for Science and Technology, Egypt

Study Record Dates

• First Submitted: October 14, 2024
• First Posted: October 22, 2024
• Study Start: February 1, 2023
• Primary Completion: August 15, 2024
• Study Completion: August 30, 2024
• Last Updated: October 22, 2024

Record last verified: 2024-10

Locations

EG (1)