Prospective Observational Study for Nutritional Evaluation of Infants Receiving Amino Acid-Based Formula at Assiut University Children's Hospital
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Mean anthropometric z-scores (WAZ, LAZ, WLZ)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 1 Month 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants aged 1 to 12 months at the time of enrollment.
- •Infants who are exclusevel or predominantly fed amino acid-based formula (AAF) in addition to elimination diet for at least 12 consecutive weeks.
- •Infants who are diagnosed as CMPA by CoMiSS score ≥ 10 and confirmed by OFC test.
- •Infants with informed parental or guardian consent to participate in the study.
排除标准
- •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.
结局指标
主要结局
Mean anthropometric z-scores (WAZ, LAZ, WLZ)
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Length-for-Age Z-score(At the time of enrollment.)
- Head Circumference-for-Age Z-score(At the time of enrollment.)
- Gastrointestinal Symptoms(At the time of enrollment (parental report).)
研究者
Merna Emeel Fahmy Abd Elmalak
Pediatric Resident
Assiut University