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临床试验/CTRI/2024/06/068470
CTRI/2024/06/068470尚未招募不适用

A STUDY ON THE ASSOCIATION OF HUMAN MILK FEEDING DURING THE NEONATAL HOSPITALIZATION ON NEURODEVELOPMENT OF LBW BABIES OF 18 TO 20 MONTHS OF AGE A ONE YEAR COHORT STUDY

Jawaharlal Nehru Medical College KLE University Belgavi1 个研究点 分布在 1 个国家目标入组 184 人开始时间: 2024年6月14日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
184
试验地点
1
主要终点
To study the association of human milk feeding (mother’s own milk and or donor human milk) during the neonatal hospitalisation on the neurodevelopment of low birth weight babies of 18 to 20 months of age.

研究概览

简要总结

Breast milk serves as the initial nourishment in a child’s life, providing a healthy and nutritious beginning. Mother’s own milk diet in infants has substantial supporting evidence for reducing the occurrence of late onset sepsis, Bronchopulmonary dysplasia, Retinopathy of Prematurity (ROP), and Necrotizing Enterocolitis (NEC). Additionally, it enhances feeding tolerance, shortens hospital stays, and decreases medical costs.

The less developed brain of preterm infants, particularly those with LBW, theoretically could benefit from feeding maternal milk since it contains critical nutrients such as long chain poly- unsaturated fatty acids (LCPUFA) and possibly other neurotrophic factors.

Low-birth-weight infants, being among the most vulnerable in our society, require special attention and a heightened commitment to comprehensive care, particularly in nutritional aspects influencing neurodevelopment.

Numerous studies emphasize the significance of a mother’s own milk, while only a few focus on pasteurized donor human milk. Additionally, there’s a scarcity of Indian research on the link between pasteurized donor human milk and neurodevelopment, prompting the initiation of this study.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Month(s) 至 20.00 Month(s)(—)
性别
All

入选标准

  • Low birth weight babies (less than 2.5kg) 2) Babies who were received donor human milk for ≥ 5 days duration.
  • Parents of babies who give consent and are willing to take part in the study.
  • Babies living within 50 KM from DR.
  • Prabhakar Kore Hospital and Medical Research Centre , Belagavi, Karnataka.

排除标准

  • Babies with congenital or chromosomal anomalies that might contribute to poor developmental outcome.
  • Birth asphyxia .
  • Babies with blindness, hearing and speech disabilities (cranial nerve injuries) 4) Babies with history of feeding difficulties.

结局指标

主要结局

To study the association of human milk feeding (mother’s own milk and or donor human milk) during the neonatal hospitalisation on the neurodevelopment of low birth weight babies of 18 to 20 months of age.

时间窗: The study will be conducted for a span of one year

次要结局

  • To study association of the total duration of human milk feeding (mother’s own milk and/or donor human milk) on the growth of infant at 18-20 months of age.(The study will be conducted for a span of one year)

研究者

发起方
Jawaharlal Nehru Medical College KLE University Belgavi
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Anusha Shridhar

Jawaharlal Nehru Medical College, KLE University.

研究点 (1)

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