Malnutrition Clinical Trial
— experimentalOfficial title:
Effects of High vs. Standard Protein Intake in the Weight Gain and Renal Function Security in Newborn Extreme Premature
Verified date | June 2015 |
Source | Coordinación de Investigación en Salud, Mexico |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 52 |
Est. completion date | February 2013 |
Est. primary completion date | January 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A to 4 Weeks |
Eligibility |
Inclusion Criteria: 1. Preterm infant of less than 32 gestational weeks and weighting less than 1500g Exclusion Criteria: 1. Preterm infant with severe congenital malformations. 2. Patients with acute kidney failure. 3. Inform consent form not signed. |
Country | Name | City | State |
---|---|---|---|
Mexico | Instituto Mexicano del Seguro Social | León | Guanajuato |
Lead Sponsor | Collaborator |
---|---|
Coordinación de Investigación en Salud, Mexico | Instituto Mexicano del Seguro Social, Universidad de Guanajuato |
Mexico,
Kotsopoulos K, Benadiba-Torch A, Cuddy A, Shah PS. Safety and efficacy of early amino acids in preterm <28 weeks gestation: prospective observational comparison. J Perinatol. 2006 Dec;26(12):749-54. Epub 2006 Oct 5. — View Citation
Moltu SJ, Blakstad EW, Strømmen K, Almaas AN, Nakstad B, Rønnestad A, Brække K, Veierød MB, Drevon CA, Iversen PO, Westerberg AC. Enhanced feeding and diminished postnatal growth failure in very-low-birth-weight infants. J Pediatr Gastroenterol Nutr. 2014 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Renal function: urea, creatinina and urea nitrogen | 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). | at 48h - 28 days |
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