Nutritional Evaluation of Infants Receiving Amino Acid-Based Formula

N/ANot Yet RecruitingNCT07174999

Assiut University160 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

160

Conditions

Cow's Milk Protein Allergy Protein Intolerance Failure to Thrive

Eligibility

Sex: ALLMin age: 1 MonthMax age: 12 Months

Medical Language ↔ Plain English

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.

Locations (1)

Assiut University

Asyut, Egypt

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: At the time of enrollment (single assessment).

Secondary Outcomes

Length-for-Age Z-score

Measurement of length-for-age z-score according to WHO growth standards.

Time frame: At the time of enrollment.

Head Circumference-for-Age Z-score

Measurement of head circumference-for-age z-score according to WHO growth standards.

Time frame: At the time of enrollment.

Gastrointestinal Symptoms

Assessment of gastrointestinal tolerance including vomiting, diarrhea, and constipation

Time frame: At the time of enrollment (parental report).

Central Contacts

Merna Emeel Fahmy, MBBCh, Pediatric Resident

CONTACT

01202626579 Merna.17289584@med.aun.edu.eg

Osama Mahmoud Elasheer, prof

CONTACT

01001348864 asheer1970@aun.edu.eg

Data from ClinicalTrials.gov

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