Amino Acid and Acylcarnitine Profiles in Premature Neonates

Prematurity Clinical Trial

Official title:

How Illness and Nutritional Support Influence Amino Acid and Acylcarnitine Profiles in Premature Neonates

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00865150
• Other study ID #: PDX-001-08
• Status: Completed
• Phase: N/A
• First received: March 18, 2009
• Last updated: February 28, 2012
• Start date: April 2009
• Est. completion date: February 2012

Study information

• Verified date: February 2012
• Source: Mednax Center for Research, Education and Quality
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical 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 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1003
• Est. completion date: February 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 23 Weeks to 31 Weeks

Eligibility

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Neonatal Screening
• Parenteral Nutrition
• Premature Birth
• Prematurity

Locations

Country	Name	City	State
United States	McLeod Regional Medical Center	Florence	South Carolina
United States	Memorial Hospital South Bend	South Bend	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Mednax Center for Research, Education and Quality

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		42 Days of Life	No
Secondary	Occurrence of any of the following: death, cholestatic liver disease, positive blood or CSF culture, NEC, IVH, or respiratory support at 36 weeks PMA.		42 Days of Life	No