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

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

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 Overview

• Status: Unknown
• Conditions: Malnutrition; Growth Failure; Nutrition; Nutrition Disorder, Infant; Growth Failure in Medically Complex Infants; Malnutrition in Medically Complex Infants; Nutrition in Medically Complex Infants
• Intervention / Treatment: Behavioral: Standardized Medical Nutrition Therapy; Behavioral: Usual Care

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Behavioral: 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.
ACTIVE_COMPARATOR: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome 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)
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

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Candice R Poland, MS, RD, LD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 1, 2018
• Primary Completion (ANTICIPATED): June 1, 2019
• Study Completion (ANTICIPATED): June 1, 2019

Study Registration Dates

• First Submitted: April 30, 2018
• First Submitted That Met QC Criteria: May 10, 2018
• First Posted (ACTUAL): May 11, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 16, 2018
• Last Update Submitted That Met QC Criteria: May 10, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Malnutrition; Nutrition Disorders; Failure to Thrive; Infant Nutrition Disorders
• Other Study ID Numbers: HSC-MS-18-0276

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No