Amino Acid and Acylcarnitine Profiles in Premature Neonates
How Illness and Nutritional Support Influence Amino Acid and Acylcarnitine Profiles in Premature Neonates
Primary Hypotheses of the study include:
- Metabolic profiles are influenced by gestational age, chronological age, type and degree of nutritional support and illness
- Metabolic profiles differ between neonates who receive commercial formula and neonates who receive primarily human breast milk
- Neonates who develop parenteral associated cholestasis have metabolic markers that identify at risk patients (high serum urea nitrogen, citrulline, histidine, methionine, and succinyl carnitine and low thyroxine, serine and glutamate)
- Neonates that have hypothyroidism have abnormal metabolic profiles (low tyrosine levels)
研究概览
详细说明
Malnutrition is a common problem in the neonatal intensive care unit. Recent studies indicate that prematurely born neonates commonly develop a severe nutritional deficit during the first weeks after birth, referred to as extrauterine growth restriction. Despite an increase in growth during the second month of hospitalization, many neonates are ultimately discharged home having grown inadequately. The early nutritional deficit affects weight gain as well as growth in length and head circumference. Aggressive administration of parenteral amino acids to improve protein accretion rates in very preterm neonates has been supported in the literature. Although tolerance of high dose amino acids has been described, researchers acknowledge that sensitive tests to monitor amino acid toxicity are not readily available in the clinical setting.
The goals of this study are:
- To better define normal amino acid and acylcarnitine values and how they change in premature neonates
- To measure the effect nutritional support has (human breastmilk vs. formula) on amino acid and acylcarnitines profiles
- To measure the effect of illness (parenteral nutrition associated cholestasis) on amino acid and acylcarnitine profiles
- To better define abnormal metabolic profiles (low tyrosine levels) in neonates that have hypothyroidism.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Indiana
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South Bend、Indiana、美国、46601
- Memorial Hospital South Bend
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South Carolina
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Florence、South Carolina、美国、29506
- McLeod Regional Medical Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria
- Documentation of informed consent
- Inborn
- Less than or equal to twenty four (24) hours of age
- Gestational age between twenty three (23) weeks and 0/7 days and thirty one (31) weeks and 0/7 days as per the best estimate by the neonatologist
- If subject is transferred to another hospital, the ability to obtain follow-up data on outcomes
- No known major anomalies (inborn error of metabolism, chromosomal abnormalities, cyanotic congenital heart disease, gastroschisis, omphalocele, diaphragmatic hernia or other major gastrointestinal anomalies, major neurological injury or anomaly, and multiple congenital anomalies)
Exclusion Criteria
- Outborn (transferred for intensive care from another hospital)
- Greater than twenty four (24) hours of age
- Gestational age < 23 weeks or > 31 weeks
- Any known major congenital anomalies
学习计划
研究是如何设计的?
设计细节
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Metabolic Profile - Serum amino acid, acylcarnitine and thyroxine levels. Day of birth, (first 24 hours), Day 7, (parenteral nutrition effect), Day 28, (enteral nutrition effect), Day 42, or discharge (established enteral feeding and growth)
大体时间:42 Days of Life
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42 Days of Life
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Occurrence of any of the following: death, cholestatic liver disease, positive blood or CSF culture, NEC, IVH, or respiratory support at 36 weeks PMA.
大体时间:42 Days of Life
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42 Days of Life
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合作者和调查者
赞助
调查人员
- 首席研究员:Reese Clark, MD、Pediatrix Medical Group, Inc.
出版物和有用的链接
一般刊物
- Clark RH, Chace DH, Spitzer AR. Impact of l-carnitine supplementation on metabolic profiles in premature infants. J Perinatol. 2017 May;37(5):566-571. doi: 10.1038/jp.2016.253. Epub 2017 Jan 12.
- Jacob J, Kamitsuka M, Clark RH, Kelleher AS, Spitzer AR. Etiologies of NICU deaths. Pediatrics. 2015 Jan;135(1):e59-65. doi: 10.1542/peds.2014-2967. Epub 2014 Dec 8. Erratum In: Pediatrics. 2015 Apr;135(4):775-7.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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