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

Malnutrition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03522558
• Other study ID #: HSC-MS-18-0276
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: June 1, 2019

Study information

• Verified date: May 2018
• Source: The University of Texas Health Science Center, Houston
• Contact: Candice R Poland, MS, RD, LD
• Phone: 713-486-6961
• Email: Candice.R.Poland[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: June 1, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 2 Years

Eligibility

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

Related Conditions & MeSH terms

• Failure to Thrive
• Growth Failure
• Growth Failure in Medically Complex Infants
• Infant Nutrition Disorders
• Malnutrition
• Malnutrition in Medically Complex Infants
• Nutrition
• Nutrition Disorder, Infant
• Nutrition Disorders
• Nutrition in Medically Complex Infants

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with a 20% improvement in growth velocity at 1 year corrected gestational age (CGA)		4 months corrected gestational age (CGA)
Primary	Number of participants with a 20% improvement in growth velocity at 1 year corrected gestational age (CGA)		8 months corrected gestational age (CGA)
Primary	Number of participants with a 20% improvement in growth velocity at 1 year corrected gestational age (CGA)		12 months corrected gestational age (CGA)
Primary	Number of participants with a 20% improvement in growth velocity at 1 year corrected gestational age (CGA)		1 year corrected gestational age (CGA)
Secondary	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)
Secondary	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)
Secondary	Severity of malnutrition as assessed by the AND/ASPEN criteria		1 year corrected gestational age (CGA)
Secondary	Number of emergency department visits		1 year corrected gestational age (CGA)
Secondary	Number of hospitalizations		1 year corrected gestational age (CGA)
Secondary	Length of stay	number of hospital days	about 3 to 7 days