Abnormal Renal FunctionPhase 2experimentalNCT02478086
Effects of High vs. Standard Protein Intake in Newborn Extreme Premature
A Phase 2 study testing use amine acids parenteral 3.5g and use amine acids parenteral 4g in people with Abnormal Renal Function and Malnutrition, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 4 weeksHealthy volunteers can take part
- Conditions the study is for
- Abnormal Renal Function, Malnutrition
- What is being tested?
- use amine acids parenteral 3.5g and use amine acids parenteral 4g
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteMexico
- Study dates
- Aug 2012to Feb 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 4 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 1. Preterm infant of less than 32 gestational weeks and weighting less than 1500g
Who cannot join
- Preterm infant with severe congenital malformations.
- Patients with acute kidney failure.
- Inform consent form not signed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of High vs. Standard Protein Intake in the Weight Gain and Renal Function Security in Newborn Extreme Premature
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.
Read more
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.
Read the 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
- 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)
- Conditions
- Abnormal Renal Function, Malnutrition
- Being tested
- use amine acids parenteral 3.5g, use amine acids parenteral 4g
- Keywords
- amino acids, renal function, extreme premature
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
use amine acids parenteral 3.5gDietary supplement
Also called Levamin Nomo 10% 3.5g / kg / day
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.
use amine acids parenteral 4gDietary supplement
Also called Levamin Nomo 10% 4g / kg / day
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: use amine acids parenteral 3.5g |
| 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. Receives: Dietary Supplement: use amine acids parenteral 4g |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: at 48h - 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2015 (estimated)
- Study startAug 2012
- Primary completionJan 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Abnormal Renal FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coordinación de Investigación en Salud, Mexico
- Sponsor type
- Other government
- Collaborators
- Instituto Mexicano del Seguro Social, Universidad de Guanajuato
- Responsible party
- Principal investigator, Guadalupe Gómez Rodríguez, Coordinación de Investigación en Salud, Mexico
- Investigators
- Victor Godinez, Director, Study director, Instituto Mexicano del Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02478086
- Sponsor's protocol ID
- R-2012-1002-63
- Acronym
- experimental
- Status last verified
- Jun 2015
- First submitted
- 31 May 2015
- Last updated
- 23 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24556755Kotsopoulos 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.
PubMed 17024139
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High vs. Standard Protein Intake in the Weight Gain and Renal Function Security in Newborn Extreme Premature
- ClinicalTrials.gov ID
- NCT02478086
- Acronym / sponsor ID
- experimental / R-2012-1002-63
- Conditions
- Abnormal Renal Function, Malnutrition
- Keywords
- amino acids, renal function, extreme premature
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Coordinación de Investigación en Salud, MexicoOther government
- Collaborators
- Instituto Mexicano del Seguro Social, Universidad de Guanajuato
- Study start
- Aug 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 23 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| use amine acids parenteral 3.5g | Experimental | Dietary Supplement: use amine acids parenteral 3.5gAmino 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. |
| use amine acids parenteral 4g | Experimental | Dietary Supplement: use amine acids parenteral 4gGroup 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. |
Who may qualify
- Ages
- 1 day to 4 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 1. Preterm infant of less than 32 gestational weeks and weighting less than 1500g
Key exclusion criteria (3 listed)
- Preterm infant with severe congenital malformations.
- Patients with acute kidney failure.
- Inform consent form not signed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| use amine acids parenteral 3.5gAlso: Levamin Nomo 10% 3.5g / kg / dayGroup 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 3.5g |
| use amine acids parenteral 4gAlso: Levamin Nomo 10% 4g / kg / dayGroup 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. | Dietary supplement | use amine acids parenteral 4g |
Primary outcome
Renal function: urea, creatinina and urea nitrogen
Time frame: 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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2015.
- Results publication: PubMed 24556755Moltu 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 publication: PubMed 17024139Kotsopoulos 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victor Godinez, Director study director
Instituto Mexicano del Seguro Social
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing use amine acids parenteral 3.5g and use amine acids parenteral 4g in people with Abnormal Renal Function and Malnutrition, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal function: urea, creatinina and urea nitrogen (time frame: at 48h - 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02478086, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2015.