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

Primary Purpose

Abnormal Renal Function, Malnutrition

Status
Completed
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
use amine acids parenteral 3.5g
use amine acids parenteral 4g
Sponsored by
Coordinación de Investigación en Salud, Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Abnormal Renal Function focused on measuring amino acids, renal function, extreme premature

Eligibility Criteria

1 Day - 4 Weeks (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Instituto Mexicano del Seguro Social

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

use amine acids parenteral 3.5g

use amine acids parenteral 4g

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
May 31, 2015
Last Updated
June 18, 2015
Sponsor
Coordinación de Investigación en Salud, Mexico
Collaborators
Instituto Mexicano del Seguro Social, Universidad de Guanajuato
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1. Study Identification

Unique Protocol Identification Number
NCT02478086
Brief Title
Effects of High vs. Standard Protein Intake in Newborn Extreme Premature
Acronym
experimental
Official Title
Effects of High vs. Standard Protein Intake in the Weight Gain and Renal Function Security in Newborn Extreme Premature
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Coordinación de Investigación en Salud, Mexico
Collaborators
Instituto Mexicano del Seguro Social, Universidad de Guanajuato

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
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 Preterm infant with severe congenital malformation Patients with acute kidney failure. Inform consent form not signed. Methodology For the accomplishment of the present trial all premature patients weighting less than 1500g and less than 32 weeks of age were included, and also the patients referred by the other units in less than 24h after birth. Randomization was carried out using closed envelopes with the assigned amino acid doses, constituting two groups: group A with an initial doses of 2.5 g/kg/day with daily increments of 0.5 g/kg/day until reaching 3.5 g/kg/day; 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. The amino acids administered are from Pisa Laboratory (Levamin Nomo 10%, ®), with the following composition in every 100 ml: 511 mg of L-isoleucine, 725mg of L-leucine, 934 mg of L-licina, 396 mg of L-methionine, 724 mg of L-phenylalanine, 514 of L-threonine, 180mg of L-tryptophan, 668 mg of L-valine, 1025 mg of L-arginine, 443 mg of L-histidine, 1469 mg of L-alanine, 40 mg of L-Sistine, 1198 mg of Glycine, 590 mg of L-proline, 500 mg of L-serine, 235 mg of L-aspartic acid, 309 mg of L-glutamine acid and 36mg of L-tyrosine. 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. The presence of sepsis was diagnosed using clinical signs of systemic inflammatory response and a positive blood culture, necrotizing enterocolitis was diagnosed using Bell's criteria and permeable artery duct was defined by a connection between the aorta and the pulmonary artery with a left to right shunt; death was also evaluated. Sample Size The sample size was calculated for 24 patients in each group as necessary to detect a delta of 15% in the weight variable (beta error of 20 % and alpha error of 5%). 10% losses were assumed, resulting in a total of 28 needed patients per group. Statistical analysis Central tendency measures were used for all variables and also chi square test for qualitative variables were applied, T-student test for continuous variables ad for multiple measurements ANOVA Test was applied. The software used was NCSS v. 8.0 (Kaysville, Utah USA)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abnormal Renal Function, Malnutrition
Keywords
amino acids, renal function, extreme premature

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
use amine acids parenteral 3.5g
Arm Type
Experimental
Arm Description
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.
Arm Title
use amine acids parenteral 4g
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
use amine acids parenteral 3.5g
Other Intervention Name(s)
Levamin Nomo 10% 3.5g / kg / day
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
use amine acids parenteral 4g
Other Intervention Name(s)
Levamin Nomo 10% 4g / kg / day
Intervention Description
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.
Primary Outcome Measure Information:
Title
Renal function: urea, creatinina and urea nitrogen
Description
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).
Time Frame
at 48h - 28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
4 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 1. Preterm infant of less than 32 gestational weeks and weighting less than 1500g Exclusion Criteria: Preterm infant with severe congenital malformations. Patients with acute kidney failure. Inform consent form not signed.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victor Godinez, Director
Organizational Affiliation
Instituto Mexicano del Seguro Social
Official's Role
Study Director
Facility Information:
Facility Name
Instituto Mexicano del Seguro Social
City
León
State/Province
Guanajuato
ZIP/Postal Code
37200
Country
Mexico

12. IPD Sharing Statement

Citations:
PubMed Identifier
24556755
Citation
Moltu SJ, Blakstad EW, Strommen K, Almaas AN, Nakstad B, Ronnestad A, Braekke K, Veierod 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 Mar;58(3):344-51. doi: 10.1097/MPG.0000000000000220.
Results Reference
result
PubMed Identifier
17024139
Citation
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. doi: 10.1038/sj.jp.7211611. Epub 2006 Oct 5.
Results Reference
result

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

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