PrematurityNCT00865150
Amino Acid and Acylcarnitine Profiles in Premature Neonates
An observational study of Prematurity and Neonatal Screening, run by Pediatrix at 2 sites in United States.
Trial summary
Primary Hypotheses of the study include: Metabolic profiles are influenced by gestational age, chronological age, type and degree of nutritional support and illness Metabolic profiles differ between neonates who receive commercial formula and neonates who receive primarily human breast milk Neonates who develop… Read more about this study
- Who is it for?
- Ages 23 to 31 weeksHealthy volunteers can take part
- Conditions the study is for
- Prematurity, Neonatal Screening, Parenteral Nutrition
- How many people
- 1,003 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2009to Feb 2012
- Phase
- Observational
- 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 23 to 31 weeks
- All sexes
- Healthy volunteers accepted
- Child
Study population: Hospital
Who may be able to join
- Documentation of informed consent
- Inborn
- Less than or equal to twenty four (24) hours of age
- Gestational age between twenty three (23) weeks and 0/7 days and thirty one (31) weeks and 0/7 days as per the best estimate by the neonatologist
- If subject is transferred to another hospital, the ability to obtain follow-up data on outcomes
- No known major anomalies (inborn error of metabolism, chromosomal abnormalities, cyanotic congenital heart disease, gastroschisis, omphalocele, diaphragmatic hernia or other major gastrointestinal anomalies, major neurological injury or anomaly, and multiple congenital anomalies)
Who cannot join
- Outborn (transferred for intensive care from another hospital)
- Greater than twenty four (24) hours of age
- Gestational age < 23 weeks or > 31 weeks
- Any known major congenital anomalies
Trial locations and contacts
2 sites in 1 country.
United States2 sites
McLeod Regional Medical Center
Florence, South Carolina, 29506
Memorial Hospital South Bend
South Bend, Indiana, 46601
About this study
Official title: How Illness and Nutritional Support Influence Amino Acid and Acylcarnitine Profiles in Premature Neonates
Primary Hypotheses of the study include:
- Metabolic profiles are influenced by gestational age, chronological age, type and degree of nutritional support and illness
- Metabolic profiles differ between neonates who receive commercial formula and neonates who receive primarily human breast milk
- Neonates who develop parenteral associated cholestasis have metabolic markers that identify at risk patients (high serum urea nitrogen, citrulline, histidine, methionine, and succinyl carnitine and low thyroxine, serine and glutamate)
- Neonates that have hypothyroidism have abnormal metabolic profiles (low tyrosine levels)
Read the detailed description
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. Aggressive administration of parenteral amino acids to improve protein accretion rates in very preterm neonates has been supported in the literature. Although tolerance of high dose amino acids has been described, researchers acknowledge that sensitive tests to monitor amino acid toxicity are not readily available in the clinical setting.
The goals of this study are:
- To better define normal amino acid and acylcarnitine values and how they change in premature neonates
- To measure the effect nutritional support has (human breastmilk vs. formula) on amino acid and acylcarnitines profiles
- To measure the effect of illness (parenteral nutrition associated cholestasis) on amino acid and acylcarnitine profiles
- To better define abnormal metabolic profiles (low tyrosine levels) in neonates that have hypothyroidism.
- Conditions
- Prematurity, Neonatal Screening, Parenteral Nutrition
- Keywords
- Prematurity, Neonatal screening, Parenteral nutrition, Amino acids, Acylcarnitine
- Medical subject headings
- Premature Birth, Hyperphagia
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic Profile - Serum amino acid, acylcarnitine and thyroxine levels. Day of birth, (first 24 hours), Day 7, (parenteral nutrition effect), Day 28, (enteral nutrition effect), Day 42, or discharge (established enteral feeding and growth)
Measured: 42 Days of Life
Secondary outcomes (1)
Occurrence of any of the following: death, cholestatic liver disease, positive blood or CSF culture, NEC, IVH, or respiratory support at 36 weeks PMA.
Measured: 42 Days 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 Mar 2009 (estimated)
- Study startApr 2009
- Primary completionAug 2011
- Study completionFeb 2012
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 PrematurityStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,003 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pediatrix
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Reese Clark, MD, Principal investigator, Pediatrix Medical Group, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00865150
- Sponsor's protocol ID
- PDX-001-08
- Status last verified
- Feb 2012
- First submitted
- 18 Mar 2009
- Last updated
- 1 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Clark RH, Chace DH, Spitzer AR. Impact of l-carnitine supplementation on metabolic profiles in premature infants. J Perinatol. 2017 May;37(5):566-571. doi: 10.1038/jp.2016.253. Epub 2017 Jan 12.
PubMed 28079870Jacob J, Kamitsuka M, Clark RH, Kelleher AS, Spitzer AR. Etiologies of NICU deaths. Pediatrics. 2015 Jan;135(1):e59-65. doi: 10.1542/peds.2014-2967. Epub 2014 Dec 8.
PubMed 25489010
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Illness and Nutritional Support Influence Amino Acid and Acylcarnitine Profiles in Premature Neonates
- ClinicalTrials.gov ID
- NCT00865150
- Acronym / sponsor ID
- PDX-001-08
- Conditions
- Prematurity, Neonatal Screening, Parenteral Nutrition
- Keywords
- Prematurity, Neonatal screening, Parenteral nutrition, Amino acids, Acylcarnitine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,003 participants (actual)
- Lead sponsor
- PediatrixUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 19 Mar 2009 (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.
Primary Hypotheses of the study include:
- Metabolic profiles are influenced by gestational age, chronological age, type and degree of nutritional support and illness
- Metabolic profiles differ between neonates who receive commercial formula and neonates who receive primarily human breast milk
- Neonates who develop parenteral associated cholestasis have metabolic markers that identify at risk patients (high serum urea nitrogen, citrulline, histidine, methionine, and succinyl carnitine and low thyroxine, serine and glutamate)
- Neonates that have hypothyroidism have abnormal metabolic profiles (low tyrosine levels)
Detailed description
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. Aggressive administration of parenteral amino acids to improve protein accretion rates in very preterm neonates has been supported in the literature. Although tolerance of high dose amino acids has been described, researchers acknowledge that sensitive tests to monitor amino acid toxicity are not readily available in the clinical setting.
The goals of this study are:
- To better define normal amino acid and acylcarnitine values and how they change in premature neonates
- To measure the effect nutritional support has (human breastmilk vs. formula) on amino acid and acylcarnitines profiles
- To measure the effect of illness (parenteral nutrition associated cholestasis) on amino acid and acylcarnitine profiles
- To better define abnormal metabolic profiles (low tyrosine levels) in neonates that have hypothyroidism.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 23 to 31 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Hospital
Key inclusion criteria (6 listed)
- Documentation of informed consent
- Inborn
- Less than or equal to twenty four (24) hours of age
- Gestational age between twenty three (23) weeks and 0/7 days and thirty one (31) weeks and 0/7 days as per the best estimate by the neonatologist
- If subject is transferred to another hospital, the ability to obtain follow-up data on outcomes
Key exclusion criteria (4 listed)
- Outborn (transferred for intensive care from another hospital)
- Greater than twenty four (24) hours of age
- Gestational age < 23 weeks or > 31 weeks
- Any known 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.
Primary outcome
Metabolic Profile - Serum amino acid, acylcarnitine and thyroxine levels. Day of birth, (first 24 hours), Day 7, (parenteral nutrition effect), Day 28, (enteral nutrition effect), Day 42, or discharge (established enteral feeding and growth)
Time frame: 42 Days of Life
1 secondary outcome
Occurrence of any of the following: death, cholestatic liver disease, positive blood or CSF culture, NEC, IVH, or respiratory support at 36 weeks PMA.
Time frame: 42 Days 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 1 Mar 2012.
- Derived from this study: PubMed 28079870Clark RH, Chace DH, Spitzer AR. Impact of l-carnitine supplementation on metabolic profiles in premature infants. J Perinatol. 2017 May;37(5):566-571. doi: 10.1038/jp.2016.253. Epub 2017 Jan 12.
- Derived from this study: PubMed 25489010Jacob J, Kamitsuka M, Clark RH, Kelleher AS, Spitzer AR. Etiologies of NICU deaths. Pediatrics. 2015 Jan;135(1):e59-65. doi: 10.1542/peds.2014-2967. Epub 2014 Dec 8.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prematurity and Neonatal Screening, run by Pediatrix at 2 sites 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 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: finished, as of the sponsor's last update on 1 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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?
Metabolic Profile - Serum amino acid, acylcarnitine and thyroxine levels. Day of birth, (first 24 hours), Day 7, (parenteral nutrition effect), Day 28, (enteral nutrition effect), Day 42, or discharge (established enteral feeding and growth) (time frame: 42 Days of Life). 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 NCT00865150, 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 1 Mar 2012.