Growth Failure, Growth Failure in Medically Complex Infants, Malnutrition, Malnutrition in Medically Complex Infants, Nutrition, Nutrition Disorder, Infant, Nutrition in Medically Complex Infants
Conditions
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.
Interventions
BEHAVIORALStandardized 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.
BEHAVIORALUsual 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.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 2 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who are malnourished | 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. |
| Severity of malnutrition as assessed by the AND/ASPEN criteria | 1 year corrected gestational age (CGA) | — |
| Number of participants with growth failure | 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. |
| Number of hospitalizations | 1 year corrected gestational age (CGA) | — |
| Length of stay | about 3 to 7 days | number of hospital days |
| Number of emergency department visits | 1 year corrected gestational age (CGA) | — |
Countries
United States
Contacts
Primary ContactCandice R Poland, MS, RD, LD
Outcome results
None listed