Premature BirthPhase 3TPNACNCT01062724
Total Parenteral Nutrition Associated Cholestasis (TPNAC) and Plasma Amino Acid Levels in Neonates
A Phase 3 study testing Primene 10 % from Baxter in people with Premature Birth, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
Trial summary
The purpose of this study is to analyze if the infants who received Primene solution, have lower serum levels of methionine and cysteine and higher serum levels of taurine, we also analyze if the infants who received Primene solution develop TPN-associated cholestasis in a smaller proportion than those who received… Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Premature Birth
- What is being tested?
- Primene 10 % from Baxter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteMexico
- Study dates
- May 2011to Jul 2016
- Phase
- Phase 3
- 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 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Newborns greater than 1500 g who enter the Intensive Care Unit and their pathology requiring total parenteral nutritional support (necrotizing enterocolitis, intestinal atresia, short bowel syndrome).
- Gestational age greater than 30 weeks
- Patients with normal liver function tests for their age, prior to the initiation of total parenteral nutrition.
- Authorization from both parents or legal guardian for recruiting of the child into the study with consent signed form after the purpose and procedures have been explained
Who cannot join
- Patients with acute renal failure
- Congenital liver disease, end-stage liver disease
- Patients with liver damage secondary to viral or bacterial infection
- Patients with liver damage secondary to drugs
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Intensive Care Unit and Nutrition Parenteral Department, Pediatric Hospital , Instituto Mexicano del Seguro Social
Mexico City, Mexico City, 06720
About this study
Official title: Effect of Two Amino Acid Solutions on Blood Amino Acid Levels and Frequency of Cholestasis in Neonates
The purpose of this study is to analyze if the infants who received Primene solution, have lower serum levels of methionine and cysteine and higher serum levels of taurine, we also analyze if the infants who received Primene solution develop TPN-associated cholestasis in a smaller proportion than those who received Trophamine solution.
Read the detailed description
Total parenteral nutrition is an essential component of the care of premature and ill infants. Prolonged parenteral nutrition is associated with complications affecting the hepatobiliary system, such as cholelithiasis, cholestasis, and steatosis. The most common of these is total parenteral nutrition-associated cholestasis (TPNAC), that occurs because of reduced bile flow from the liver into the duodenum. Cholestasis causes liver damage and in some cases, death. Infant and neonate are at particular risk for this complication. The incidence of TPNAC ranges from 7.4 to 84%.
Animal studies have implicated amino acids in the production of cholestasis; whereas studies in human neonates suggest a direct effect of amino acid infusions on the hepatocyte canalicular membrane. An appropriate amino acid solution might compensate for the metabolic immaturity of infants and perhaps reduce total parenteral nutrition associated complications such as cholestasis. Therefore, is important to compare the frequency of cholestasis and blood amino acid concentration during Primene and Trophamine use.
- Conditions
- Premature Birth
- Being tested
- Primene 10 % from Baxter
- Keywords
- Cholestasis, TPN, Neonates, Primene, Trophamine, Methionine, Cysteine, Taurine, Total Parenteral Nutrition
- Medical subject headings
- Premature Birth, Cholestasis, Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primene 10 % from BaxterOther
Also called PRIMENE 10%, code IMSS 2512 01 01
Primene solution will be calculated in g/kg/day and administered in ml/day Active Comparator: Trophamine This group of neonates will be receive the Trophamine amino acid solution from Pisa laboratories and the other arm will be receive a Primene amino acid solution (10 %) from Baxter laboratories. For infants identified, daily intakes (g/kg/d) of parenteral protein, carbohydrate and fat and daily enteral intake (ml/kg/d) of breast milk or formula will be record.
| Study group | Role | What they receive |
|---|---|---|
| Trophamine | No intervention | This group of neonates will be receive the Trophamine amino acids solution from Pisa laboratories as an active comparator with Primene. The infants in this group will receive, daily intakes (g/kg/d) of parenteral protein, carbohydrate and fat or daily enteral intake (ml/kg/d). Besides, the intake of breast milk or formula will be record, during the first 28 days of total parenteral nutrition. |
| Primene 10% from Baxter | Experimental | This group of neonates will be receive the Primene amino acids solution (10 %) from Baxter laboratories as other active comparator with Trophamine. The infants in this group will receive, daily intakes (g/kg/d) of parenteral protein, carbohydrate and fat or daily enteral intake (ml/kg/d). Besides, the intake of breast milk or formula will be record, during the first 28 days of total parenteral nutrition. Receives: Other: Primene 10 % from Baxter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Amino Acid levels and Frequency of Cholestasis in Neonates
Measured: At baseline, day 7, 14, 21 and 28 of the administration of total parenteral nutrition (TPN
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2010 (estimated)
- Study startMay 2011
- Primary completionNov 2015
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premature BirthStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coordinación de Investigación en Salud, Mexico
- Sponsor type
- Other government
- Collaborators
- Instituto Mexicano del Seguro Social
- Responsible party
- Principal investigator, María de Lourdes Barbosa Cortés, Coordinación de Investigación en Salud, Mexico
- Investigators
- Maria de Lourdes Barbosa-Cortés, MSc, Principal investigator, Instituto Mexicano del Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01062724
- Sponsor's protocol ID
- 2009-785-080
- Acronym
- TPNAC
- Status last verified
- Feb 2016
- First submitted
- 3 Feb 2010
- Last updated
- 9 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD012273. doi: 10.1002/14651858.CD012273.pub2.
PubMed 33006765
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Two Amino Acid Solutions on Blood Amino Acid Levels and Frequency of Cholestasis in Neonates
- ClinicalTrials.gov ID
- NCT01062724
- Acronym / sponsor ID
- TPNAC / 2009-785-080
- Conditions
- Premature Birth
- Keywords
- Cholestasis, TPN, Neonates, Primene, Trophamine, Methionine, Cysteine, Taurine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Coordinación de Investigación en Salud, MexicoOther government
- Collaborators
- Instituto Mexicano del Seguro Social
- Study start
- May 2011 (actual)
- Primary completion
- Nov 2015 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 4 Feb 2010 (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.
The purpose of this study is to analyze if the infants who received Primene solution, have lower serum levels of methionine and cysteine and higher serum levels of taurine, we also analyze if the infants who received Primene solution develop TPN-associated cholestasis in a smaller proportion than those who received Trophamine solution.
Detailed description
Total parenteral nutrition is an essential component of the care of premature and ill infants. Prolonged parenteral nutrition is associated with complications affecting the hepatobiliary system, such as cholelithiasis, cholestasis, and steatosis. The most common of these is total parenteral nutrition-associated cholestasis (TPNAC), that occurs because of reduced bile flow from the liver into the duodenum. Cholestasis causes liver damage and in some cases, death. Infant and neonate are at particular risk for this complication. The incidence of TPNAC ranges from 7.4 to 84%.
Animal studies have implicated amino acids in the production of cholestasis; whereas studies in human neonates suggest a direct effect of amino acid infusions on the hepatocyte canalicular membrane. An appropriate amino acid solution might compensate for the metabolic immaturity of infants and perhaps reduce total parenteral nutrition associated complications such as cholestasis. Therefore, is important to compare the frequency of cholestasis and blood amino acid concentration during Primene and Trophamine use.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trophamine | No intervention | –This group of neonates will be receive the Trophamine amino acids solution from Pisa laboratories as an active comparator with Primene. The infants in this group will receive, daily intakes (g/kg/d) of parenteral protein, carbohydrate and fat or daily enteral intake (ml/kg/d). Besides, the intake of breast milk or formula will be record, during the first 28 days of total parenteral nutrition. |
| Primene 10% from Baxter | Experimental | Other: Primene 10 % from BaxterThis group of neonates will be receive the Primene amino acids solution (10 %) from Baxter laboratories as other active comparator with Trophamine. The infants in this group will receive, daily intakes (g/kg/d) of parenteral protein, carbohydrate and fat or daily enteral intake (ml/kg/d). Besides, the intake of breast milk or formula will be record, during the first 28 days of total parenteral nutrition. |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Newborns greater than 1500 g who enter the Intensive Care Unit and their pathology requiring total parenteral nutritional support (necrotizing enterocolitis, intestinal atresia, short bowel syndrome).
- Gestational age greater than 30 weeks
- Patients with normal liver function tests for their age, prior to the initiation of total parenteral nutrition.
- Authorization from both parents or legal guardian for recruiting of the child into the study with consent signed form after the purpose and procedures have been explained
Key exclusion criteria (4 listed)
- Patients with acute renal failure
- Congenital liver disease, end-stage liver disease
- Patients with liver damage secondary to viral or bacterial infection
- Patients with liver damage secondary to drugs
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 |
|---|---|---|
| Primene 10 % from BaxterAlso: PRIMENE 10%, code IMSS 2512 01 01Primene solution will be calculated in g/kg/day and administered in ml/day Active Comparator: Trophamine This group of neonates will be receive the Trophamine amino acid solution from Pisa laboratories and the other arm will be receive a Primene amino acid solution (10 %) from Baxter laboratories. For infants identified, daily intakes (g/kg/d) of parenteral protein, carbohydrate and fat and daily enteral intake (ml/kg/d) of breast milk or formula will be record. | Other | Primene 10% from Baxter |
Primary outcome
Blood Amino Acid levels and Frequency of Cholestasis in Neonates
Time frame: At baseline, day 7, 14, 21 and 28 of the administration of total parenteral nutrition (TPN
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2017.
- Derived from this study: PubMed 33006765Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD012273. doi: 10.1002/14651858.CD012273.pub2.
- Individual participant dataSharing planned: Undecided
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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.
Maria de Lourdes Barbosa-Cortés, MSc principal investigator
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 3 study testing Primene 10 % from Baxter in people with Premature Birth, 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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 9 Jun 2017. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early. Results are not available in the source record.
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?
Blood Amino Acid levels and Frequency of Cholestasis in Neonates (time frame: At baseline, day 7, 14, 21 and 28 of the administration of total parenteral nutrition (TPN). 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 NCT01062724, which also lists 1 linked publication.
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 9 Jun 2017.