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

The University of Texas Health Science Center, Houston200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

200

Conditions

Growth Failure in Medically Complex Infants Growth Failure Malnutrition in Medically Complex Infants Malnutrition Nutrition in Medically Complex Infants

Interventions

Standardized Medical Nutrition TherapyBEHAVIORAL

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 CareBEHAVIORAL

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.

Eligibility

Sex: ALLMax age: 2 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of participants with a 20% improvement in growth velocity at 1 year corrected gestational age (CGA)

Time frame: 4 months corrected gestational age (CGA)

Number of participants with a 20% improvement in growth velocity at 1 year corrected gestational age (CGA)

Time frame: 8 months corrected gestational age (CGA)

Number of participants with a 20% improvement in growth velocity at 1 year corrected gestational age (CGA)

Time frame: 12 months corrected gestational age (CGA)

Number of participants with a 20% improvement in growth velocity at 1 year corrected gestational age (CGA)