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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03522558
Other study ID # HSC-MS-18-0276
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 1, 2018
Est. completion date June 1, 2019

Study information

Verified date May 2018
Source The University of Texas Health Science Center, Houston
Contact Candice R Poland, MS, RD, LD
Phone 713-486-6961
Email Candice.R.Poland@uth.tmc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 200
Est. completion date June 1, 2019
Est. primary completion date June 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 2 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
United States The University of Texas Health Science Center at Houston Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants with a 20% improvement in growth velocity at 1 year corrected gestational age (CGA) 4 months corrected gestational age (CGA)
Primary Number of participants with a 20% improvement in growth velocity at 1 year corrected gestational age (CGA) 8 months corrected gestational age (CGA)
Primary Number of participants with a 20% improvement in growth velocity at 1 year corrected gestational age (CGA) 12 months corrected gestational age (CGA)
Primary Number of participants with a 20% improvement in growth velocity at 1 year corrected gestational age (CGA) 1 year corrected gestational age (CGA)
Secondary Number of participants with growth failure Growth failure ("Failure to Thrive") is defined as crossing 2 growth percentiles in a downward trajectory in the first year of life per child. 1 year corrected gestational age (CGA)
Secondary Number of participants who are malnourished The Academy of Nutrition and Dietetics/American Society for Parenteral and Enteral Nutrition (AND/ASPEN) criteria are used for diagnosing pediatric malnutrition. 1 year corrected gestational age (CGA)
Secondary Severity of malnutrition as assessed by the AND/ASPEN criteria 1 year corrected gestational age (CGA)
Secondary Number of emergency department visits 1 year corrected gestational age (CGA)
Secondary Number of hospitalizations 1 year corrected gestational age (CGA)
Secondary Length of stay number of hospital days about 3 to 7 days
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