Assiut University
Asyut, Egypt
NCT Number: NCT07174999
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.
Trial opening soon.
Get Notified1 month–12 month
All sexes
Observational
Asyut, Egypt
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At the time of enrollment.
Measurement of length-for-age z-score according to WHO growth standards.
Time frame: At the time of enrollment.
Measurement of head circumference-for-age z-score according to WHO growth standards.
Time frame: At the time of enrollment (parental report).
Assessment of gastrointestinal tolerance including vomiting, diarrhea, and constipation
Contact information is provided by the study sponsor or research team.
Merna Emeel Fahmy, MBBCh, Pediatric Resident
CONTACT
Osama Mahmoud Elasheer, prof
CONTACT
Assiut University
Other
Prospective Observational Study for Nutritional Evaluation of Infants Receiving Amino Acid-Based Formula at Assiut University Children's Hospital
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.