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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standardized Medical Nutrition Therapy | Experimental | 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. |
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| Usual Care | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standardized Medical Nutrition Therapy | Behavioral | 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. |
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Candice R Poland, MS, RD, LD | Contact | 713-486-6961 | Candice.R.Poland@uth.tmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Candice R Poland, MS, RD, LD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
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|
| Usual Care | Behavioral | 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. |
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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 |
| ID | Term |
|---|---|
| D005183 | Failure to Thrive |
| D044342 | Malnutrition |
| D007228 | Infant Nutrition Disorders |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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