NCT00865150

Brief 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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,003

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2009

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 19, 2009

Completed
13 days until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

March 1, 2012

Status Verified

February 1, 2012

Enrollment Period

2.3 years

First QC Date

March 18, 2009

Last Update Submit

February 28, 2012

Conditions

PrematurityNeonatal ScreeningParenteral Nutrition

Keywords

PrematurityNeonatal screeningParenteral nutritionAmino acidsAcylcarnitine

Outcome Measures

Primary Outcomes (1)

  • 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

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.

    42 Days of Life

Eligibility Criteria

Age23 Weeks - 31 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Hospital

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Memorial Hospital South Bend

South Bend, Indiana, 46601, United States

Location

McLeod Regional Medical Center

Florence, South Carolina, 29506, United States

Location

Related Publications (2)

  • 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.

    PMID: 28079870DERIVED

  • Jacob 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.

    PMID: 25489010DERIVED

MeSH Terms

Conditions

Premature BirthHyperphagia

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Reese Clark, MD

    Pediatrix Medical Group, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2009

First Posted

March 19, 2009

Study Start

April 1, 2009

Primary Completion

August 1, 2011

Study Completion

February 1, 2012

Last Updated

March 1, 2012

Record last verified: 2012-02

Locations

US(2)