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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

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.

Condition or disease Intervention/treatment Phase
Growth Failure in Medically Complex Infants Growth Failure Malnutrition in Medically Complex Infants Malnutrition Nutrition in Medically Complex Infants Nutrition Nutrition Disorder, Infant Behavioral: Standardized Medical Nutrition Therapy Behavioral: Usual Care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Medical Nutrition Therapy for Medically Complex Infants in the Pediatric Outpatient Setting. A Quality Improvement Project
Estimated Study Start Date : July 1, 2018
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.

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.
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.




Primary Outcome Measures :
  1. 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) ]
  2. 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) ]
  3. 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) ]
  4. 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) ]

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Severity of malnutrition as assessed by the AND/ASPEN criteria [ Time Frame: 1 year corrected gestational age (CGA) ]
  4. Number of emergency department visits [ Time Frame: 1 year corrected gestational age (CGA) ]
  5. Number of hospitalizations [ Time Frame: 1 year corrected gestational age (CGA) ]
  6. Length of stay [ Time Frame: about 3 to 7 days ]
    number of hospital days



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03522558


Contacts
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Contact: Candice R Poland, MS, RD, LD 713-486-6961 Candice.R.Poland@uth.tmc.edu

Locations
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United States, Texas
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Contact: Candice R Poland, MS, RD, LD    713-486-6961    Candice.R.Poland@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: Candice R Poland, MS, RD, LD The University of Texas Health Science Center, Houston
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Responsible Party: Candice Rachel Poland, Registered Dietitian, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT03522558    
Other Study ID Numbers: HSC-MS-18-0276
First Posted: May 11, 2018    Key Record Dates
Last Update Posted: May 16, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders
Infant Nutrition Disorders
Failure to Thrive