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临床试验/CTRI/2025/08/093864
CTRI/2025/08/093864尚未招募不适用

Comparison of protein intake in preterm infants: milk analysis versus nutrition audit – A prospective observational study.

Jawaharlal Institute of Post Graduate Medical Education and Research(JIPMER)1 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2025年9月15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
125
试验地点
1
主要终点
To assess the agreement between protein intake using breast milk analyser measurements and the fixed protein content as per unit nutrition audit during week 4 (22 to 25 days) of life.

研究概览

简要总结

The study will be conducted at the tertiary neonatal care unit, JIPMER, Puducherry for a period of 2 years. Preterm infants delivered before 31 weeks of gestation will be enrolled after getting informed written consent from the parents after 10 days of life. Data on mother’s details and perinatal details will be collected. Data on neonatal course will be prospectively collected till discharge. 5ml breast milk will be collected on Day 10-14, Day 22-25 and analysis for macronutrient composition will be done using  breastmilk analyser. This data will be compared with the standard content used for routine nutrition audit at postnatal weeks 2 and 4.

研究设计

研究类型
Observational

入排标准

年龄范围
10.00 Day(s) 至 24.00 Day(s)(—)
性别
All

入选标准

  • Preterm neonates born less than 31 + 0 weeks of gestation who are on full feeds and predominantly on mothers’ own milk and their mothers.

排除标准

  • Preterm neonates who expired before 2 weeks of life.

结局指标

主要结局

To assess the agreement between protein intake using breast milk analyser measurements and the fixed protein content as per unit nutrition audit during week 4 (22 to 25 days) of life.

时间窗: Week 4(22-25 days)

次要结局

  • To analyze the protein, fat, carbohydrate, and energy content by a milk analyser in week 2 (10 to 14 days) of life(Week 2(10-14 days))
  • To compare protein, fat, carbohydrate, and energy composition of the milk samples between mothers with and without any co-morbidities(Week 2(10-14 days))
  • To study the average calorie and protein intake per day from second week till discharge from the unit nutrition chart (updated weekly)(Week 2 till discharge)
  • To correlate weight delta z score from birth to discharge and the milk energy and protein content at around second week and fourth week of life(Week 2(10-14 days))

研究者

发起方
Jawaharlal Institute of Post Graduate Medical Education and Research(JIPMER)
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Merin Mathew

Jawaharlal Institute of Post Graduate Medical Education and Research(JIPMER)

研究点 (1)

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