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临床试验/NCT02182973
NCT02182973已完成不适用

Donor Human Milk for Infants With Neonatal Abstinence Syndrome

Neolac Inc dba Medolac Laboratories1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2014年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
12
试验地点
1
主要终点
Percentage of Infants Achieving a GI Subscore >2 Over the Study Period

研究概览

简要总结

This study is designed to develop pilot data on the acceptability and benefit of donor human milk for infants undergoing pharmacologic treatment for NAS. Specifically, gastrointestinal (GI) sub-scores, as well as total scores, will be compared between infants historically fed formula and those enrolled in a 2-week donor human milk study period.

Purpose of study: to test the following null hypothesis:

Infants with a diagnosis of neonatal abstinence syndrome (NAS) due to in-utero exposure to opiates, fed donor human milk, will have similar GI/feeding sub-scores of the Finnegan scoring tool when compared to (historic) infants fed formula.

A rejection of the null hypothesis will be used to design a randomized trial of donor human milk in infants with NAS.

详细描述

Background

Neonatal Abstinence Syndrome (NAS) is a drug withdrawal syndrome that occurs primarily after antenatal exposure to opiates. Symptoms may be present at birth, but often peak at 48-72 after delivery. The onset of symptoms is affected by the half-life of the opiate used during pregnancy in combination with maternal and infant metabolism. The incidence of NAS has increased substantially since 2000 both nationally and in the Commonwealth of Kentucky, leading to a significant increase in healthcare resource utilization and (Figure 1).

The 2012 National Survey on Drug Use and Health found that illicit drug abuse affected ~130,000 pregnancies in the United States from 2011-2012 and that approximately 20% of those pregnancies (26,000) involved opiates. (SAMSA Center for Behavioral Health Statistics and Quality, National Survey on Drug Use and Health, 2009-2012). Patrick et al. utilized the Kids' Inpatient Database (KID) from the Agency for Health Care Research and Quality to evaluate the incidence of maternal opiate use during pregnancy (1). He and his team noted a substantial increase in the number of mothers using opiates - 1.19 per 1000 hospital births in 2000 to 5.63 per 1000 hospital births in 2009. As a result, there was an increased diagnosis of NAS from 1.20 per 1000 hospital births in 2000 to 3.39 per 1000 hospital births in 2009. This is a 2.8-fold increase which means that every hour of every day, 1 neonate in the United States undergoes drug withdrawal.

The Kentucky Injury Prevention and Research Center reported that 824 infants in the state of Kentucky were hospitalized for neonatal withdrawal after exposure to opiates in 2012. This represents an 18% increase from 2011 and a 4.5 fold increase from 2005. (Kentucky Injury Prevention and Research Center. Data for 2010-2012). NAS is an issue of epidemic proportions both for Kentucky and the nation. It results in prolonged hospitalizations and increased healthcare costs. In 2009, the total charges for NAS treatment were noted to be approximately $720 million nationally, up from approximately $190 million in 2000 (1). Kentucky data from 2012 report a $40 million dollar cost for neonatal drug withdrawal treatment, which has increased from $200,000 in 2000. (Kentucky Injury Prevention and Research Center. Data for 2010-2012). The majority of these costs (75-80%) are paid by the state Medicaid program (Figure 2).

Precipitous removal of exogenous opiates at the time of delivery results in unopposed stimulation by cyclic adenosine monophosphate (cAMP) and which increases norepinephrine levels and results in clinical symptoms of drug withdrawal in the neonate (2). Symptoms include central nervous system (CNS) signs (seizures, irritability, tremors), autonomic disturbances (sweating, yawning, nasal stuffiness, low grade fever, mottling) and gastrointestinal (GI) dysfunction (diarrhea, vomiting, poor feeding, and regurgitation). The cohort of withdrawal symptoms is dictated by the location of µ opioid receptors, which are concentrated in the brain but are also found in sensory nerves, mast cells and in the GI tract(3).

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
38 Weeks 至 42 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Term infants (>37 completed weeks) with a diagnosis of NAS, due to maternal use of opiates (only)
  • Infants will have had moderate to severe NAS symptoms (Finnegan scores >8) that required pharmacologic therapy but have been stabilized (captured) on oral morphine (Finnegan scores less than 8 for 24 hours)
  • Breastfeeding is contraindicated or the mother has chosen formula feeding for her baby

排除标准

  • Preterm infants (<37 completed weeks at birth)
  • Infants with intrauterine growth restriction (BW <10th percentile for gestational age)
  • Mother is providing her own milk

结局指标

主要结局

Percentage of Infants Achieving a GI Subscore >2 Over the Study Period

时间窗: 2 weeks

Minimum score:0; Maximum score 13. Higher scores mean more GI distress

次要结局

  • Weight Change at 2 Weeks(2 weeks)
  • Head Circumference Change at 2 Weeks(2 weeks)

研究者

发起方
Neolac Inc dba Medolac Laboratories
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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