Malnutrition Clinical Trial
Official title:
Medical Nutrition Therapy for Medically Complex Infants in the Pediatric Outpatient Setting. A Quality Improvement Project
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | The University of Texas Health Science Center at Houston | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
The University of Texas Health Science Center, Houston |
United States,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
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