Cow's Milk Protein Allergy Protein Intolerance Failure to Thrive
Conditions
Keywords
Amino Acid-Based Formula Infant Nutrition Growth Assessment Food Allergy Nutritional Evaluation
Brief summary
This study aims to evaluate the growth parameters and nutritional status of infants who are receiving amino acid-based formula due to cow's milk protein allergy or other medical indications.
Detailed description
This prospective observational study will assess infants who are exclusively fed amino acid-based formula. Participants will be followed over a period of 6 months, and anthropometric measurements (weight, length, head circumference) will be recorded monthly. Growth velocity and nutritional status will be analyzed and compared with WHO growth standards.
Interventions
None listed
Sponsors
Assiut University
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
1 Months to 12 Months
Healthy volunteers
No
Inclusion criteria
1. Infants aged 1 to 12 months at the time of enrollment. 2. Infants who are exclusevel or predominantly fed amino acid-based formula (AAF) in addition to elimination diet for at least 12 consecutive weeks. 3. Infants who are diagnosed as CMPA by CoMiSS score ≥ 10 and confirmed by OFC test. 4. Infants with informed parental or guardian consent to participate in the study.
Exclusion criteria
* 1- Infants with congenital anomalies or syndromes affecting growth and development (e.g., trisomy 21, major cardiac defects). 2- Infants with chronic systemic illnesses unrelated to feeding (e.g., cystic fibrosis, chronic kidney disease). 3- Infants receiving additional specialized nutrition support (e.g., parenteral nutrition or tube feeding not involving AAF). 4- Infants with incomplete or insufficient medical records at the time of assessment.5- Infants who have been on AAF for less than 4 weeks or whose feeding regimen is not stable. 6- Infants whose parents or legal guardians decline or withdraw informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean anthropometric z-scores (WAZ, LAZ, WLZ) | Single assessment at enrollment. | Mean weight-for-age, length-for-age, and weight-for-length z-scores for the study population compared to WHO reference. |
| Weight-for-Age Z-score (WAZ) - prevalence of underweight | Single assessment at enrollment. | Prevalence of underweight (weight-for-age z-score \< -2) among infants receiving amino acid-based formula, calculated according to WHO growth standards. |
| Nutritional Status (Weight-for-Age Z-sco | At the time of enrollment (single assessment). | Assessment of weight-for-age z-score in infants receiving amino acid-based formula compared to WHO growth standards. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length-for-Age Z-score | At the time of enrollment. | Measurement of length-for-age z-score according to WHO growth standards. |
| Head Circumference-for-Age Z-score | At the time of enrollment. | Measurement of head circumference-for-age z-score according to WHO growth standards. |
| Gastrointestinal Symptoms | At the time of enrollment (parental report). | Assessment of gastrointestinal tolerance including vomiting, diarrhea, and constipation |
Countries
Egypt
Contacts
Primary ContactMerna Emeel Fahmy, MBBCh, Pediatric Resident
Backup ContactOsama Mahmoud Elasheer, prof
Outcome results
None listed