Breast FeedingPostnatalNCT06653309
Interdisciplinary Pharmaceutical Analysis: Artificial Milk Effects on Children and Postnatal Women's Health
An observational study of Breast Feeding, run by Delta University for Science and Technology at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 month to 1 year
- Conditions the study is for
- Breast Feeding
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2023to 30 Aug 2024
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 1 year
- All sexes
- No healthy volunteers
- Child
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%.
Who may be able to join
- 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
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Basma Wageah Mohamed Mohamed Elrefay
Al Manşūrah, Al Dakahlya, 35111
About this study
Official title: Interdisciplinary Pharmaceutical Analysis: Artificial Milk Effects on Neonates and Postnatal Women's Health
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 .
Read the 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
- Keywords
- Postnatal - Artificial Milk
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 . |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (1)
raising awareness about the burden of depressive symptoms many women experience in postnatal women care
This tool was developed by Cox et al. (1996) (Cox et al., 1996). A standardized scale will be used to assess postnatal depression symptoms in postnatal women. The EPDS is a 10-item self-report scale assessing the common symptoms of depression.
Scoring system Each item is scored on a 4-point scale (O-3), the minimum and maximum total score ranging from 0-30, respectively.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start1 Feb 2023
- Primary completion15 Aug 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast FeedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Delta University for Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Basma Wageah Mohamed Mohamed Elrefay, Delta University for Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06653309
- Sponsor's protocol ID
- Artificial Milk postnatal
- Acronym
- Postnatal
- Status last verified
- Oct 2024
- First submitted
- 14 Oct 2024
- Last updated
- 22 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interdisciplinary Pharmaceutical Analysis: Artificial Milk Effects on Neonates and Postnatal Women's Health
- ClinicalTrials.gov ID
- NCT06653309
- Acronym / sponsor ID
- Postnatal / Artificial Milk postnatal
- Conditions
- Breast Feeding
- Keywords
- Postnatal - Artificial Milk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Delta University for Science and TechnologyUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 15 Aug 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 22 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 . |
Who may qualify
- Ages
- 1 month to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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%.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- • Children with major congenital anomalies or genetic disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
increase global awareness about assessments of breast feeding and its difficulties
Time frame: 3 months
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
1 secondary outcome
raising awareness about the burden of depressive symptoms many women experience in postnatal women care
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Feeding, run by Delta University for Science and Technology at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
increase global awareness about assessments of breast feeding and its difficulties (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2024.