MalnutritionPhase 3NCT00120926
Dose Comparison of Amino Acids on Growth in Premature Neonates
A Phase 3 study testing Parenteral Nutrition in people with Malnutrition, run by Pediatrix at 1 site in United States.
Trial summary
Malnutrition is a common problem in the neonatal intensive care unit. Recent studies indicate that prematurely born neonates commonly develop a severe nutritional deficit during the first weeks after birth, referred to as extrauterine growth restriction. Read more about this study
- Who is it for?
- Ages 0 years to 48 hours
- Conditions the study is for
- Malnutrition
- What is being tested?
- Parenteral Nutrition
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Jun 2006
- 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 0 years to 48 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Documentation of informed consent
- Inborn
- Gestational age between 23 weeks and 0/7 days and 29 weeks and 6/7 days
- If subject is transferred to another hospital, the ability to obtain follow-up data on outcomes
- No major anomalies
- Ability to begin parenteral nutrition within the first 48 hours after birth
Who cannot join
- Outborn
- Gestational age < 23 weeks or >= 30 weeks
- Any major congenital anomalies
Trial locations and contacts
1 site in 1 country.
United States1 site
McLeod Regional Medical Center
Florence, South Carolina, 29506
About this study
Official title: Randomized Control Trial Evaluating the Effect of Two Different Doses of Amino Acids on Growth and Serum Amino Acids in Premature Neonates Admitted to the NICU
Malnutrition is a common problem in the neonatal intensive care unit. Recent studies indicate that prematurely born neonates commonly develop a severe nutritional deficit during the first weeks after birth, referred to as extrauterine growth restriction. Despite an increase in growth during the second month of hospitalization, many neonates are ultimately discharged home having grown inadequately. The early nutritional deficit affects weight gain as well as growth in length and head circumference.
Growth measurements such as weight, length, and head circumference, however, are macroscopic measures of nutritional status and underestimate the physiologic consequences of prolonged nutritional deprivation. Energy and micronutrient deficiencies alter growth at a cellular and tissue level before macroscopic measures are altered. In the brain, for instance, energy is required for cell division and neuronal growth, glial cell function, and myelination. Energy deprivation may consequently alter neuronal function and growth, resulting in adverse neurodevelopmental outcomes.
Read more
Immunocompetence also appears to be sensitive to the untoward effects of energy and nutritional deficiency. Malnourished neonates often exhibit immune deficiencies related to inadequate protein intake that compound an already immature immune system. Such immunodeficiency results in susceptibility to infectious agents that creates substantial morbidity and mortality to the course of intensive care for premature infants.
A recent study suggests that postnatal malnutrition and growth restriction are inevitable if current recommended dietary intakes are followed. Multicenter studies show that variation in dietary intake accounts for 45% of the variation in growth. Hence, efforts have focused on determining whether nutritional deficiency and the observed growth restriction of premature infants can be prevented through the use of more optimal nutritional intake. In addition, inadequate protein support may be a primary cause for growth failure.
Based on animal studies showing high in utero amino acid flux observed during the latter phase of gestation, Thureen et al have suggested the use of higher doses of amino acid supplementation in order to minimize growth restriction and improve outcomes of premature infants. However there are no large human trials that demonstrate that this approach promotes better growth or that it is safe. While small doses of amino acids may be inadequate to promote normal growth, high doses may lead to elevated serum amino acid levels and increase the occurrence of toxicity. Through the implementation of a multicenter, randomized trial and tandem mass spectrometry, the investigators propose to evaluate the effects of two distinct strategies of amino acid supplementation on serum amino acid profiles and growth of premature infants during the first 28 days of life.
- Conditions
- Malnutrition
- Being tested
- Parenteral Nutrition
- Keywords
- Premature neonate, Parenteral nutrition, Growth, Amino Acids, Nutrition
- Medical subject headings
- Malnutrition, Premature Birth, Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parenteral NutritionDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is growth velocity for first 28 days of life calculated as: weight gain, head circumference, length
Secondary outcomes (1)
Secondary outcomes include serum amino acid profiles measured on: day 7 of life, day 28 of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2005 (estimated)
- Study startAug 2005
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 150 participants
Sponsor and investigators
- Lead sponsor
- Pediatrix
- Sponsor type
- University, hospital or other
- Investigators
- Reese Clark, MD, Principal investigator, Pediatrix Medical Group, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00120926
- Sponsor's protocol ID
- PDX05-001
- Status last verified
- Sep 2006
- First submitted
- 11 Jul 2005
- Last updated
- 28 Sep 2006
- Results posted
- No
Publications
Thureen PJ, Melara D, Fennessey PV, Hay WW Jr. Effect of low versus high intravenous amino acid intake on very low birth weight infants in the early neonatal period. Pediatr Res. 2003 Jan;53(1):24-32. doi: 10.1203/00006450-200301000-00008.
PubMed 12508078Amari 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 33006765Kelleher AS, Clark RH, Steinbach M, Chace DH, Spitzer AR; Pediatrix Amino-Acid Study Group. The influence of amino-acid supplementation, gestational age and time on thyroxine levels in premature neonates. J Perinatol. 2008 Apr;28(4):270-4. doi: 10.1038/jp.2008.5. Epub 2008 Feb 21.
PubMed 18288119Steinbach M, Clark RH, Kelleher AS, Flores C, White R, Chace DH, Spitzer AR; Pediatrix Amino-Acid Study Group. Demographic and nutritional factors associated with prolonged cholestatic jaundice in the premature infant. J Perinatol. 2008 Feb;28(2):129-35. doi: 10.1038/sj.jp.7211889. Epub 2007 Dec 6.
PubMed 18059467Clark RH, Chace DH, Spitzer AR; Pediatrix Amino Acid Study Group. Effects of two different doses of amino acid supplementation on growth and blood amino acid levels in premature neonates admitted to the neonatal intensive care unit: a randomized, controlled trial. Pediatrics. 2007 Dec;120(6):1286-96. doi: 10.1542/peds.2007-0545.
PubMed 18055678
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial Evaluating the Effect of Two Different Doses of Amino Acids on Growth and Serum Amino Acids in Premature Neonates Admitted to the NICU
- ClinicalTrials.gov ID
- NCT00120926
- Acronym / sponsor ID
- PDX05-001
- Conditions
- Malnutrition
- Keywords
- Premature neonate, Parenteral nutrition, Growth, Amino Acids, Nutrition
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants
- Lead sponsor
- PediatrixUniversity, hospital or other
- Study start
- Aug 2005
- Study completion
- Jun 2006
- First posted
- 19 Jul 2005 (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.
Malnutrition is a common problem in the neonatal intensive care unit. Recent studies indicate that prematurely born neonates commonly develop a severe nutritional deficit during the first weeks after birth, referred to as extrauterine growth restriction. Despite an increase in growth during the second month of hospitalization, many neonates are ultimately discharged home having grown inadequately. The early nutritional deficit affects weight gain as well as growth in length and head circumference.
Growth measurements such as weight, length, and head circumference, however, are macroscopic measures of nutritional status and underestimate the physiologic consequences of prolonged nutritional deprivation. Energy and micronutrient deficiencies alter growth at a cellular and tissue level before macroscopic measures are altered. In the brain, for instance, energy is required for cell division and neuronal growth, glial cell function, and myelination. Energy deprivation may consequently alter neuronal function and growth, resulting in adverse neurodevelopmental outcomes.
Immunocompetence also appears to be sensitive to the untoward effects of energy and nutritional deficiency. Malnourished neonates often exhibit immune deficiencies related to inadequate protein intake that compound an already immature immune system. Such immunodeficiency results in susceptibility to infectious agents that creates substantial morbidity and mortality to the course of intensive care for premature infants.
A recent study suggests that postnatal malnutrition and growth restriction are inevitable if current recommended dietary intakes are followed. Multicenter studies show that variation in dietary intake accounts for 45% of the variation in growth. Hence, efforts have focused on determining whether nutritional deficiency and the observed growth restriction of premature infants can be prevented through the use of more optimal nutritional intake. In addition, inadequate protein support may be a primary cause for growth failure.
Based on animal studies showing high in utero amino acid flux observed during the latter phase of gestation, Thureen et al have suggested the use of higher doses of amino acid supplementation in order to minimize growth restriction and improve outcomes of premature infants. However there are no large human trials that demonstrate that this approach promotes better growth or that it is safe. While small doses of amino acids may be inadequate to promote normal growth, high doses may lead to elevated serum amino acid levels and increase the occurrence of toxicity. Through the implementation of a multicenter, randomized trial and tandem mass spectrometry, the investigators propose to evaluate the effects of two distinct strategies of amino acid supplementation on serum amino acid profiles and growth of premature infants during the first 28 days of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 0 years to 48 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Documentation of informed consent
- Inborn
- Gestational age between 23 weeks and 0/7 days and 29 weeks and 6/7 days
- If subject is transferred to another hospital, the ability to obtain follow-up data on outcomes
- No major anomalies
Key exclusion criteria (3 listed)
- Outborn
- Gestational age < 23 weeks or >= 30 weeks
- Any major congenital anomalies
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 |
|---|---|---|
| Parenteral Nutrition | Drug | – |
Primary outcome
The primary outcome is growth velocity for first 28 days of life calculated as: weight gain, head circumference, length
1 secondary outcome
Secondary outcomes include serum amino acid profiles measured on: day 7 of life, day 28 of life
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 28 Sep 2006.
- Background: PubMed 12508078Thureen PJ, Melara D, Fennessey PV, Hay WW Jr. Effect of low versus high intravenous amino acid intake on very low birth weight infants in the early neonatal period. Pediatr Res. 2003 Jan;53(1):24-32. doi: 10.1203/00006450-200301000-00008.
- 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.
- Derived from this study: PubMed 18288119Kelleher AS, Clark RH, Steinbach M, Chace DH, Spitzer AR; Pediatrix Amino-Acid Study Group. The influence of amino-acid supplementation, gestational age and time on thyroxine levels in premature neonates. J Perinatol. 2008 Apr;28(4):270-4. doi: 10.1038/jp.2008.5. Epub 2008 Feb 21.
- Derived from this study: PubMed 18059467Steinbach M, Clark RH, Kelleher AS, Flores C, White R, Chace DH, Spitzer AR; Pediatrix Amino-Acid Study Group. Demographic and nutritional factors associated with prolonged cholestatic jaundice in the premature infant. J Perinatol. 2008 Feb;28(2):129-35. doi: 10.1038/sj.jp.7211889. Epub 2007 Dec 6.
- Derived from this study: PubMed 18055678Clark RH, Chace DH, Spitzer AR; Pediatrix Amino Acid Study Group. Effects of two different doses of amino acid supplementation on growth and blood amino acid levels in premature neonates admitted to the neonatal intensive care unit: a randomized, controlled trial. Pediatrics. 2007 Dec;120(6):1286-96. doi: 10.1542/peds.2007-0545.
- Related InfoLink provided by the sponsor.
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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.
Reese Clark, MD principal investigator
Pediatrix Medical Group, Inc.
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 Parenteral Nutrition in people with Malnutrition, run by Pediatrix at 1 site in United States.
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 6 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 28 Sep 2006. 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 United States. 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 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?
The primary outcome is growth velocity for first 28 days of life calculated as: weight gain, head circumference, length. 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 NCT00120926, which also lists 5 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 28 Sep 2006.