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Randomized Clinical Trial of High vs. Standard-Calorie Formula for Methadone-Expo

美沙酮博览会高热量配方奶粉与标准热量配方奶粉的随机临床试验

基本信息

批准号：
8049612
负责人：
DEBRA L BOGEN
金额：
$ 18.43万
依托单位：
UNIVERSITY OF PITTSBURGH AT PITTSBURGH
依托单位国家：
美国
项目类别：
财政年份：
2010
资助国家：
美国
起止时间：
2010-04-01 至 2013-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8049612
关键词：
Address Age Birth Birth Weight Body Weight decreased Calories Crying Data Development Diarrhea Dietary Intervention Dose Double-Blind Method Energy Intake Enrollment Etiology Feasibility Studies Funding Hospitalization Hour Infant Infant formula Intervention Lead Length of Stay Life Low Birth Weight Infant Measures Metabolic Methadone Methods Morphine Mothers Muscle Hypertonia Muscle Tonus NIH Program Announcements National Institute of Drug Abuse Neonatal Abstinence Syndrome Newborn Infant Opiates Outcome Outpatients Pattern Performance Pharmaceutical Preparations Pilot Projects Postpartum Women Pregnancy Preventive Protocols documentation Randomized Randomized Clinical Trials Recruitment Activity Severities Sleep Substance-Related Disorders Sweat Sweating Symptoms Time Uterus Visit Vomiting Weight Weight Gain Woman design experience feeding high risk infant improved in utero infant outcome neonate pregnant pressure prevent primary outcome public health relevance standard of care sucking therapy development

项目摘要

DESCRIPTION (provided by applicant): Background: Infants exposed to methadone during pregnancy experience high rates of neonatal abstinence syndrome (NAS). Common NAS symptoms (tremulousness, increased muscle tone, sweating, excessive crying, vomiting and diarrhea) increase infants' metabolic needs. Another frequent NAS symptom, weak and uncoordinated suckling, impairs infants' ability to take in adequate calories. These combined problems compromise infant weight gain. The current standard of care for opiate-exposed infants requires evidence of poor weight gain or excessive weight loss before initiating high-calorie formula. We hypothesize that inadequate caloric intake among methadone exposed infants may result in excessive weight loss, slow weight regain and exacerbation of NAS. These factors lead to the newborn's requirement for higher morphine doses and longer duration of hospitalization. Therefore, methadone exposed infants may benefit from early caloric enhancement. A nutritional intervention for opiate-exposed infants has not been previously evaluated. This application will provide data on adequacy of recruitment, protocol feasibility, performance of selected measures, and preliminary estimates of efficacy for a comprehensive R01 submission. Specific Aims: 1. For methadone exposed infants, compare infants randomized to high (24 kcal/oz) versus standard (20 kcal/oz) formula for the following outcomes: Weight loss and gain patterns. The primary dependent measure will be days until the infant returns to birth weight. Secondary measures will be maximum percent weight loss and days to weight nadir. NAS severity measured by: a) total length of hospital stay for NAS; b) duration of NAS treatment; c) mean Finnegan scores on days 2-10; d) maximum concentration of morphine used to treat NAS. 2. Describe the suck quality at 4-6 days of age among methadone exposed infants. Evaluate the association between the infant suck quality and infant weight loss and gain patterns and measures of NAS severity. Design: Women on methadone will be recruited during pregnancy and will attend a single brief visit late in pregnancy. After delivery, infants will be randomized in a double blind trial of either high-calorie or standard- calorie formula which will be started at 72 hours after birth and be continued through 21 days of age. Infants will be weighed daily and will have outpatient study visits at 1 and 3 months. For this pilot study, up to 70 mothers will be enrolled over 18 months. This pilot study is needed to establish the feasibility of the study methods and to better estimate differences that can be observed between the groups. For the primary outcome variable, days until the infant returns to birth weight, discrete survival methods will be used. Potential Impact: Early caloric enhancement for methadone-exposed infants is inexpensive, readily available, easy to implement and could improve outcomes of these high-risk infants. High-calorie formula could result in a more normal pattern of weight loss and gain, less severe NAS symptoms and shorter hospital stays. PUBLIC HEALTH RELEVANCE: Neonatal abstinence syndrome (NAS) symptoms contribute to poor infant weight gain. Early caloric enhancement for infants exposed to methadone is inexpensive, readily available, easy to implement and could improve early outcomes for these high-risk infants. We will conduct a preliminary randomized clinical trial of high-calorie vs. standard-calorie formula for methadone exposed infants to evaluate the adequacy of recruitment, protocol feasibility and estimates of whether high-calorie formula results in more normal patterns of weight loss and gain, less severe NAS symptoms and shorter hospital stays.

描述（由申请人提供）：背景：怀孕期间接触美沙酮的婴儿患新生儿戒断综合征 (NAS) 的几率很高。常见的 NAS 症状（颤抖、肌张力增加、出汗、过度哭泣、呕吐和腹泻）会增加婴儿的代谢需求。另一种常见的 NAS 症状是吸吮无力且不协调，会损害婴儿吸收足够热量的能力。这些综合问题会影响婴儿体重的增加。目前对阿片类药物暴露婴儿的护理标准要求在开始高热量配方奶粉之前有体重增加不良或体重过度减轻的证据。我们假设，接触美沙酮的婴儿热量摄入不足可能会导致体重过度减轻、体重恢复缓慢以及 NAS 恶化。这些因素导致新生儿需要更高的吗啡剂量和更长的住院时间。因此，接触美沙酮的婴儿可能会受益于早期热量增加。此前尚未对阿片类药物暴露婴儿的营养干预进行过评估。该申请将提供有关招募充分性、方案可行性、所选措施的绩效以及综合 R01 提交的功效初步估计的数据。具体目标： 1. 对于接触美沙酮的婴儿，比较随机接受高（24 kcal/oz）配方奶粉与标准（20 kcal/oz）配方奶粉的婴儿的以下结果：体重减轻和增加模式。主要的依赖指标是婴儿恢复出生体重之前的天数。次要衡量标准是最大体重减轻百分比和体重最低点的天数。 NAS 严重程度通过以下指标衡量： a) NAS 住院总时间； b) NAS 治疗持续时间； c) 第 2-10 天的平均 Finnegan 分数； d) 用于治疗 NAS 的吗啡最大浓度。 2. 描述接触美沙酮的婴儿 4-6 天时的吸吮质量。评估婴儿吸吮质量与婴儿体重减轻和增加模式以及 NAS 严重程度测量之间的关联。设计：使用美沙酮的女性将在怀孕期间被招募，并在怀孕后期进行一次简短的访问。分娩后，婴儿将被随机参加高热量或标准热量配方奶粉的双盲试验，该试验将从出生后 72 小时开始，一直持续到 21 天。婴儿将每天称重，并在 1 个月和 3 个月时进行门诊研究访问。在这项试点研究中，多达 70 名母亲将在 18 个月内参与其中。需要进行这项试点研究来确定研究方法的可行性，并更好地估计各组之间可以观察到的差异。对于主要结果变量，即婴儿恢复出生体重之前的天数，将使用离散生存方法。潜在影响：对接触美沙酮的婴儿进行早期热量增加是廉价的、容易获得的、易于实施的，并且可以改善这些高危婴儿的预后。高热量配方奶粉可能会导致更正常的体重减轻和增加模式、减轻严重的 NAS 症状并缩短住院时间。公共卫生相关性：新生儿戒断综合征 (NAS) 症状会导致婴儿体重增加不良。对接触美沙酮的婴儿进行早期热量增加是便宜的、容易获得的、易于实施的，并且可以改善这些高危婴儿的早期结果。我们将对美沙酮暴露婴儿的高热量配方奶粉与标准热量配方奶粉进行初步随机临床试验，以评估招募的充分性、方案可行性，并估计高热量配方奶粉是否会导致更正常的体重减轻和增加模式、减轻严重的 NAS 症状和缩短住院时间。