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

Study Overview
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Brief Summary
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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.

Official Title
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Medical Nutrition Therapy for Medically Complex Infants in the Pediatric Outpatient Setting. A Quality Improvement Project

Conditions
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Malnutrition, Growth Failure in Medically Complex Infants, Malnutrition in Medically Complex Infants, Nutrition in Medically Complex Infants, Nutrition, Nutrition Disorder, Infant, Growth Failure

Intervention / Treatment
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* Behavioral: Standardized Medical Nutrition Therapy
* Behavioral: Usual Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standardized Medical Nutrition Therapy<br>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<br>* 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.<br>|
| Active Comparator: Usual Care<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with a 20% improvement in growth velocity at 1 year corrected gestational age (CGA) |  | 4 months corrected gestational age (CGA) | 
| Number of participants with a 20% improvement in growth velocity at 1 year corrected gestational age (CGA) |  | 8 months corrected gestational age (CGA) | 
| Number of participants with a 20% improvement in growth velocity at 1 year corrected gestational age (CGA) |  | 12 months corrected gestational age (CGA) | 
| Number of participants with a 20% improvement in growth velocity at 1 year corrected gestational age (CGA) |  | 1 year corrected gestational age (CGA) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| Severity of malnutrition as assessed by the AND/ASPEN criteria |  | 1 year corrected gestational age (CGA) | 
| Number of emergency department visits |  | 1 year corrected gestational age (CGA) | 
| Number of hospitalizations |  | 1 year corrected gestational age (CGA) | 
| Length of stay | number of hospital days | about 3 to 7 days |