Effects of High vs. Standard Protein Intake in Newborn Extreme Premature

Summary

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.

Conditions

• Abnormal Renal Function
• Malnutrition

Interventions

DIETARY_SUPPLEMENT

use amine acids parenteral 3.5g

Group A we administered standard doses of amino acids was administered (3.5gr) 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.

DIETARY_SUPPLEMENT

use amine acids parenteral 4g

Group B we administered high doses of amino acids was administered (4 gr) 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.

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social

  collaborator OTHER_GOV

• Universidad de Guanajuato

  collaborator OTHER

• Coordinación de Investigación en Salud, Mexico

  lead OTHER_GOV

Principal Investigators

• Victor Godinez, Director · Instituto Mexicano del Seguro Social

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

1 Day

Max Age

4 Weeks

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2012-08-31

Primary Completion

2013-01-31

Completion

2013-02-28

Countries

• Mexico

Study Locations