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Medical Nutrition Therapy for Medically Complex Infants in the Pediatric Outpatient Setting

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03522558
Recruitment Status : Unknown
Verified May 2018 by Candice Rachel Poland, The University of Texas Health Science Center, Houston.
Recruitment status was:  Not yet recruiting
First Posted : May 11, 2018
Last Update Posted : May 16, 2018
Sponsor:
Information provided by (Responsible Party):
Candice Rachel Poland, The University of Texas Health Science Center, Houston

Tracking Information
First Submitted Date  ICMJE April 30, 2018
First Posted Date  ICMJE May 11, 2018
Last Update Posted Date May 16, 2018
Estimated Study Start Date  ICMJE July 1, 2018
Estimated Primary Completion Date June 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 10, 2018)
  • Number of participants with a 20% improvement in growth velocity at 1 year corrected gestational age (CGA) [ Time Frame: 4 months corrected gestational age (CGA) ]
  • Number of participants with a 20% improvement in growth velocity at 1 year corrected gestational age (CGA) [ Time Frame: 8 months corrected gestational age (CGA) ]
  • Number of participants with a 20% improvement in growth velocity at 1 year corrected gestational age (CGA) [ Time Frame: 12 months corrected gestational age (CGA) ]
  • Number of participants with a 20% improvement in growth velocity at 1 year corrected gestational age (CGA) [ Time Frame: 1 year corrected gestational age (CGA) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 10, 2018)
  • Number of participants with growth failure [ Time Frame: 1 year corrected gestational age (CGA) ]
    Growth failure ("Failure to Thrive") is defined as crossing 2 growth percentiles in a downward trajectory in the first year of life per child.
  • Number of participants who are malnourished [ Time Frame: 1 year corrected gestational age (CGA) ]
    The Academy of Nutrition and Dietetics/American Society for Parenteral and Enteral Nutrition (AND/ASPEN) criteria are used for diagnosing pediatric malnutrition.
  • Severity of malnutrition as assessed by the AND/ASPEN criteria [ Time Frame: 1 year corrected gestational age (CGA) ]
  • Number of emergency department visits [ Time Frame: 1 year corrected gestational age (CGA) ]
  • Number of hospitalizations [ Time Frame: 1 year corrected gestational age (CGA) ]
  • Length of stay [ Time Frame: about 3 to 7 days ]
    number of hospital days
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Medical Nutrition Therapy for Medically Complex Infants in the Pediatric Outpatient Setting
Official Title  ICMJE Medical Nutrition Therapy for Medically Complex Infants in the Pediatric Outpatient Setting. A Quality Improvement Project
Brief Summary The purpose of this study is to compare standardized nutrition therapy provided by a registered dietitian (RD) at regularly scheduled intervals to usual care in terms of the ability to improve growth parameters in medically complex infants in the pediatric outpatient setting.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Growth Failure in Medically Complex Infants
  • Growth Failure
  • Malnutrition in Medically Complex Infants
  • Malnutrition
  • Nutrition in Medically Complex Infants
  • Nutrition
  • Nutrition Disorder, Infant
Intervention  ICMJE
  • Behavioral: Standardized Medical Nutrition Therapy
    Standardized Medical Nutrition Therapy will include nutrition assessment provided by a registered dietitian (RD) at initial clinic visit or first Well Child Check (WCC) and regularly scheduled nutrition follow-up at each WCC visit thereafter.
  • Behavioral: Usual Care
    At the primary care provider's discretion, a nutrition consult can be requested for the RD to perform nutrition assessment or discuss the patient's plan without full nutrition assessment, as is current practice. Currently in the Neonatal High-Risk Clinic (NHRC) and High Risk Children's Clinic (HRCC) at UTHealth, providers consult the RD as deemed appropriate with no established criteria for when to include the RD in patient care. Usual care will not be modified by the study protocol.
Study Arms  ICMJE
  • Experimental: Standardized Medical Nutrition Therapy
    Standardized Medical Nutrition Therapy will include nutrition assessment provided by a registered dietitian (RD) at initial clinic visit or first Well Child Check (WCC) and regularly scheduled nutrition follow-up at each WCC visit thereafter.
    Intervention: Behavioral: Standardized Medical Nutrition Therapy
  • Active Comparator: Usual Care
    At the primary care provider's discretion, a nutrition consult can be requested for the RD to perform nutrition assessment or discuss the patient's plan without full nutrition assessment, as is current practice. Currently in the Neonatal High-Risk Clinic (NHRC) and High Risk Children's Clinic (HRCC) at UTHealth, providers consult the RD as deemed appropriate with no established criteria for when to include the RD in patient care. Usual care will not be modified by the study protocol.
    Intervention: Behavioral: Usual Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 10, 2018)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2019
Estimated Primary Completion Date June 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients who are admitted between July, 2018 and June, 2019 to the Neonatal High-Risk Clinic (NHRC) and High Risk Children's Clinic (HRCC) at UT Health from a neonatal intensive care unit (NICU)

Exclusion Criteria:

  • short bowel syndrome,
  • requiring parenteral nutrition (PN)
  • active cancer
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 2 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03522558
Other Study ID Numbers  ICMJE HSC-MS-18-0276
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Candice Rachel Poland, The University of Texas Health Science Center, Houston
Study Sponsor  ICMJE The University of Texas Health Science Center, Houston
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Candice R Poland, MS, RD, LD The University of Texas Health Science Center, Houston
PRS Account The University of Texas Health Science Center, Houston
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP