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

Not Applicable

• Conditions: Growth Failure in Medically Complex Infants; Nutrition; Malnutrition in Medically Complex Infants; Malnutrition; Growth Failure; Nutrition in Medically Complex Infants; Nutrition Disorder, Infant
• Interventions: Behavioral: Standardized Medical Nutrition Therapy; Behavioral: Usual Care

• Registration Number: NCT03522558
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-30
• Status Verified: 2018-05
• Study First Submitted QC: 2018-05-10
• Last Update Submitted: 2018-05-10
• Study First Posted: 2018-05-11
• Last Update Posted: 2018-05-16
• Study Start: 2018-07-01
• Primary Completion: 2019-06-01
• Study Completion: 2019-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standardized Medical Nutrition Therapy	Standardized 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.
Usual Care	Usual 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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Number of hospitalizations	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.
Severity of malnutrition as assessed by the AND/ASPEN criteria	1 year corrected gestational age (CGA)
Length of stay	about 3 to 7 days	number of hospital days
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.
Number of emergency department visits	1 year corrected gestational age (CGA)

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States