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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Population | Infants receiving amino acid-based formula who are evaluated at the Nutrition and Gastroenterology Departments, Assiut University Children's Hospital. |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean anthropometric z-scores (WAZ, LAZ, WLZ) | Mean weight-for-age, length-for-age, and weight-for-length z-scores for the study population compared to WHO reference. | Single assessment at enrollment. |
| Weight-for-Age Z-score (WAZ) - prevalence of underweight | Prevalence of underweight (weight-for-age z-score < -2) among infants receiving amino acid-based formula, calculated according to WHO growth standards. | Single assessment at enrollment. |
| Nutritional Status (Weight-for-Age Z-sco | Assessment of weight-for-age z-score in infants receiving amino acid-based formula compared to WHO growth standards. | At the time of enrollment (single assessment). |
| Measure | Description | Time Frame |
|---|---|---|
| Length-for-Age Z-score | Measurement of length-for-age z-score according to WHO growth standards. | At the time of enrollment. |
| Head Circumference-for-Age Z-score | Measurement of head circumference-for-age z-score according to WHO growth standards. |
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Inclusion Criteria:
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.
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The study population will include infants aged 1 to 12 months who are exclusively or predominantly receiving amino acid-based formula (AAF) as part of their routine medical care due to established clinical indications.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Merna Emeel Fahmy, MBBCh, Pediatric Resident | Contact | 01202626579 | Merna.17289584@med.aun.edu.eg | |
| Osama Mahmoud Elasheer, prof | Contact | 01001348864 | asheer1970@aun.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Rehab Ibrahim Hassan, prof | Assiut University | Principal Investigator |
| Osama Mahmoud Elasheer, prof | Assiut University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assiut University | Asyut | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23268426 | Result | Fiocchi A, Brozek J, Schunemann H, Bahna SL, von Berg A, Beyer K, Bozzola M, Bradsher J, Compalati E, Ebisawa M, Guzman MA, Li H, Heine RG, Keith P, Lack G, Landi M, Martelli A, Rance F, Sampson H, Stein A, Terracciano L, Vieths S. World Allergy Organization (WAO) Diagnosis and Rationale for Action against Cow's Milk Allergy (DRACMA) Guidelines. World Allergy Organ J. 2010 Apr;3(4):57-161. doi: 10.1097/WOX.0b013e3181defeb9. Epub 2010 Apr 23. No abstract available. | |
| 22569527 |
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| At the time of enrollment. |
| Gastrointestinal Symptoms | Assessment of gastrointestinal tolerance including vomiting, diarrhea, and constipation | At the time of enrollment (parental report). |
| Result |
| Koletzko S, Niggemann B, Arato A, Dias JA, Heuschkel R, Husby S, Mearin ML, Papadopoulou A, Ruemmele FM, Staiano A, Schappi MG, Vandenplas Y; European Society of Pediatric Gastroenterology, Hepatology, and Nutrition. Diagnostic approach and management of cow's-milk protein allergy in infants and children: ESPGHAN GI Committee practical guidelines. J Pediatr Gastroenterol Nutr. 2012 Aug;55(2):221-9. doi: 10.1097/MPG.0b013e31825c9482. |