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"Two year outcomes after dextrose gel prophylaxis for neonatal hypoglycaemia"

“用葡萄糖凝胶预防新生儿低血糖后的两年结果”

基本信息

批准号：
10319972
负责人：
Jane Harding
金额：
$ 38.44万
依托单位：
UNIVERSITY OF AUCKLAND
依托单位国家：
美国
项目类别：
财政年份：
2018
资助国家：
美国
起止时间：
2018-01-12 至 2023-12-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10319972
关键词：
2 year old Admission activity Adverse effects Age Birth Blood Glucose Blood Tests Brain Injuries Breast Feeding Cheek structure Child Childhood Clinical assessments Cognitive Consensus Data Development Economics Environment Executive Dysfunction Exposure to Family Follow-Up Studies Formula supplementation Funding Gel Glucose Growth Guidelines Health Hour Hypersensitivity Hypoglycemia Impairment Infant Infant formula Infection Intervention Intravenous Language Lead Life Light Mothers Motion Motor Neonatal Neonatal Hypoglycemia Neonatal Intensive Care Neonatal Intensive Care Units Neurological status Newborn Infant Obesity Oral Outcome Overweight Painless Placebos Prevention Preventive measure Prophylactic treatment Randomized Randomized Controlled Trials Reporting Research Design Risk Safety Stress Testing Vision Visual Perception adverse outcome clinical examination clinical practice cost disability dosage effective therapy executive function experience feeding follow-up improved improved outcome neurodevelopment neurosensory prevent primary outcome prophylactic randomized trial routine care routine screening standardize measure visual processing

项目摘要

Abstract Hypoglycemia (low blood glucose concentration) is common, and the only readily preventable cause of brain damage in newborn babies. Approximately 1.2 million babies a year in the US are born at risk of hypoglycemia and require regular blood tests to detect this problem. If hypoglycemia does occur, it is usually treated with additional feeding, and if necessary admission to a newborn intensive care unit (NICU) for intravenous glucose. Admission to NICU separates mothers and babies, interfering with the establishment of breast- feeding, and is expensive. Dextrose gel, rubbed inside the baby's cheek, is a simple, safe, inexpensive and effective treatment to reverse neonatal hypoglycemia. A randomized trial of 2,129 babies is currently under way to determine whether dextrose gel can be used to prevent hypoglycemia. Babies at risk of neonatal hypoglycemia are randomized to dextrose or placebo gel prophylaxis. The primary outcome is admission to NICU. If gel is effective in preventing hypoglycemia and admission to NICU, it may also prevent brain damage and enhance breast-feeding. However, it is important to determine whether these effects, if they do eventuate, have any beneficial effects on later developmental, health and growth outcomes. It is also important to be sure that using gel for prevention is safe, in view of observational data that a rapid rise in blood glucose after birth may be associated with poorer developmental outcomes. This application is to follow up babies from the trial to determine if there are any benefits or adverse effects at two years' corrected age. Assessments will include standardized measures of neurological status, developmental status, executive function, vision and visual processing, physical size, general health, and family environment. Approximately 30% of babies are born at risk of hypoglycemia and hence may be eligible for dextrose gel prophylaxis if it proves effective. This follow-up study will provide crucial evidence of longer term efficacy and safety that will be essential before introduction into clinical practice.

摘要低血糖（低血糖浓度）是常见的，并且是脑缺血的唯一容易预防的原因。对新生儿的伤害。美国每年约有120万婴儿出生时有低血糖的风险需要定期验血来检测这个问题。如果确实发生低血糖，通常用以下药物治疗：额外喂养，必要时进入新生儿重症监护室（NICU）进行静脉注射葡萄糖新生儿重症监护室的入院将母亲和婴儿分开，干扰了乳房的建立- 喂养，而且很贵。葡萄糖凝胶，擦在婴儿的脸颊内，是一种简单，安全，廉价和有效的治疗逆转新生儿低血糖目前正在对2,129名婴儿进行随机试验，以确定是否葡萄糖凝胶可用于预防低血糖。有新生儿低血糖风险的婴儿被随机分配至葡萄糖或安慰剂凝胶预防。主要结局是入住NICU。如果凝胶能有效预防低血糖和进入NICU，它也可以预防脑损伤，加强母乳喂养。然而，重要的是要确定这些影响，如果它们确实发生，对以后的发育、健康和生长结果有任何有益的影响。同样重要的是，使用凝胶预防是安全的，鉴于观察数据，出生后血糖迅速上升，可能与较差的发育结果有关。此应用程序是从试验中随访婴儿，以确定是否有任何好处或不利影响， 2岁的矫正年龄评估将包括神经系统状态的标准化测量，发育状况、执行功能、视力和视觉处理、身体大小、一般健康状况，以及家庭环境。大约30%的婴儿出生时有低血糖的风险，因此可能适合使用葡萄糖凝胶预防措施，如果有效。这项后续研究将提供长期疗效的关键证据，安全性在引入临床实践之前至关重要。

项目成果

期刊论文数量（23）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Cost Analysis of Cot-Side Screening Methods for Neonatal Hypoglycaemia.

DOI：
10.1159/000489080
发表时间：
2018
期刊：
Neonatology
影响因子：
2.5
作者：
Glasgow MJ;Harding JE;Edlin R;for the CHYLD Study Team
通讯作者：
for the CHYLD Study Team

Early Feeding for the Prevention of Neonatal Hypoglycaemia: A Systematic Review and Meta-Analysis.

早期喂养预防新生儿低血糖：系统评价和荟萃分析。

DOI：
10.1159/000535503
发表时间：
2024
期刊：
Neonatology
影响因子：
2.5
作者：
Roberts,LilyF;Harding,JaneE;Crowther,CarolineA;Watson,Estelle;Wang,Zeke;Lin,Luling
通讯作者：
Lin,Luling

Strategies to improve neurodevelopmental outcomes in babies at risk of neonatal hypoglycaemia.