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临床试验/NCT02478086
NCT02478086已完成2 期

Effects of High vs. Standard Protein Intake in the Weight Gain and Renal Function Security in Newborn Extreme Premature

Coordinación de Investigación en Salud, Mexico1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2012年8月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
52
试验地点
1
主要终点
Renal function: urea, creatinina and urea nitrogen

研究概览

简要总结

Introduction:

The preterm newborn of extremely low birth weight (PNELW), endures adverse nutritional conditions to mimic intrauterine growth. It´s known that amino acids contribute to protein synthesis, but also intervene in weight gain. Most newborns receive amino acids throw parenteral nutrition at a doses of 3.5gr/k/day, that doses its unable to reach the birth weight when discharged, so the weight its below the 10th percentile, which rises the risk for presenting alterations in neurodevelopment.

Objective:

To compare a higher doses of parenteral amino acids vs. standard doses, expecting an increased weight gain in the high amino acid doses group, meanwhile following the renal function security profile

Methods:

A randomize, single blind clinical trial, carried on, in the Neonatology Service of Unidad Medica de Alta Especialidad Numero 48 of the Instituto Mexicano del Seguro Social, in the city of Leon, Mexico. Between the period of 1st August 2012 to 31 January 2013. A standard doses of amino acids was administered (3.5gr) to a control group and a high doses (4gr) to an experimental group. Weight, urea, creatinine and blood urea nitrogen (BUN) were measured weekly. In the study were included all preterm newborns (PN) weighting less than 1500 grs and with less than 32 weeks of gestational age that match all the inclusion criteria. Statics Analysis: descriptive statistics were calculates, also chi2 test and Fisher Exact test were applied to categorical variables, t-student test to continuous variables, and ANOVA in multiple groups.

详细描述

METHODS:

Types of study: randomized single-blinded clinical trial. Time and place of development: Neonatology Service (NICU, Neonatal Ward and Premature Ward) in the Unidad Medica de Alta Especialidad Número 48, of Instituto Mexican del Seguro Social in Leon, Mexico, in the period between 1st of August 2012 and 31st of January 2013. This study was approved by local ethical committees of the hospital and University of Guanajuato. Informed consent was requested in writing to parents to include their children into the study

Inclusion Criteria

  1. Preterm infant of less than 32 gestational weeks and weighting less than 1500g.

Exclusion criteria

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Investigator)

入排标准

年龄范围
1 Day 至 4 Weeks(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Preterm infant of less than 32 gestational weeks and weighting less than 1500g

排除标准

  • •Preterm infant with severe congenital malformations.
  • •Patients with acute kidney failure.
  • •Inform consent form not signed.

研究组 & 干预措施

use amine acids parenteral 3.5g

Experimental

Amino acids parenteral (Levamin Nomo 10% ®) Group A with an initial doses of amino acids until reaching 3.5 g/kg/day during 28 days.For the study of renal function baseline urea, creatinine and BUN were measured within 24 h after birth in order to avoid any alteration cost by mother alter kidney function, afterwards the same markers were measured at the day 7, 14, 21 and 28. These markers were measure using orto-clinical diagnostic series 50-0278 USA.

The anthropometric measurements were assessed weekly by the same person to avoid bias (cephalic perimeter and height); weight was measured weekly using the same scale (SECA model 3741321009, Germany). All anthropometric and lab results were kept in a collection sheet.

干预措施: use amine acids parenteral 3.5g (Dietary Supplement)

use amine acids parenteral 4g

Experimental

Group B with an initial doses of 2.5 g/kg/day with daily increments of 0.5 g/kg/day until reaching 4 g/kg/day during 34 days.Weight, urea, creatinine and blood urea nitrogen (BUN) were measured weeklyFor the study of renal function baseline urea, creatinine and BUN were measured within 24 h after birth in order to avoid any alteration cost by mother alter kidney function, afterwards the same markers were measured at the day 7, 14, 21 and 28. These markers were measure using orto-clinical diagnostic series 50-0278 USA.

The anthropometric measurements were assessed weekly by the same person to avoid bias (cephalic perimeter and height); weight was measured weekly using the same scale (SECA model 3741321009, Germany). All anthropometric and lab results were kept in a collection sheet.

干预措施: use amine acids parenteral 4g (Dietary Supplement)

结局指标

主要结局

Renal function: urea, creatinina and urea nitrogen

时间窗: at 48h - 28 days

Concerning renal function at 48h after birth and in the subsequent measurements in the 7, 14, 21, 28 day of life, the values of urea, creatinine and BUN, no statistical difference was detected. Also any values outside the reference values in the high dose amino acid group was detected (Table 4).

次要结局

未报告次要终点

研究者

发起方
Coordinación de Investigación en Salud, Mexico
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Guadalupe Gómez Rodríguez

Guadalupe Gómez Rodríguez Médico neonatologo

Coordinación de Investigación en Salud, Mexico

研究点 (1)

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