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

Primary Purpose

Growth Failure in Medically Complex Infants, Growth Failure, Malnutrition in Medically Complex Infants

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standardized Medical Nutrition Therapy
Usual Care
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Growth Failure in Medically Complex Infants

Eligibility Criteria

undefined - 2 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The University of Texas Health Science Center at Houston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Standardized Medical Nutrition Therapy

Usual Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
Severity of malnutrition as assessed by the AND/ASPEN criteria
Number of emergency department visits
Number of hospitalizations
Length of stay
number of hospital days

Full Information

First Posted
April 30, 2018
Last Updated
May 10, 2018
Sponsor
The University of Texas Health Science Center, Houston
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1. Study Identification

Unique Protocol Identification Number
NCT03522558
Brief Title
Medical Nutrition Therapy for Medically Complex Infants in the Pediatric Outpatient Setting
Official Title
Medical Nutrition Therapy for Medically Complex Infants in the Pediatric Outpatient Setting. A Quality Improvement Project
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2018 (Anticipated)
Primary Completion Date
June 1, 2019 (Anticipated)
Study Completion Date
June 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Growth Failure in Medically Complex Infants, Growth Failure, Malnutrition in Medically Complex Infants, Malnutrition, Nutrition in Medically Complex Infants, Nutrition, Nutrition Disorder, Infant

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standardized Medical Nutrition Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standardized Medical Nutrition Therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Intervention Description
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 Measure Information:
Title
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)
Title
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)
Title
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)
Title
Number of participants with a 20% improvement in growth velocity at 1 year corrected gestational age (CGA)
Time Frame
1 year corrected gestational age (CGA)
Secondary Outcome Measure Information:
Title
Number of participants with growth failure
Description
Growth failure ("Failure to Thrive") is defined as crossing 2 growth percentiles in a downward trajectory in the first year of life per child.
Time Frame
1 year corrected gestational age (CGA)
Title
Number of participants who are malnourished
Description
The Academy of Nutrition and Dietetics/American Society for Parenteral and Enteral Nutrition (AND/ASPEN) criteria are used for diagnosing pediatric malnutrition.
Time Frame
1 year corrected gestational age (CGA)
Title
Severity of malnutrition as assessed by the AND/ASPEN criteria
Time Frame
1 year corrected gestational age (CGA)
Title
Number of emergency department visits
Time Frame
1 year corrected gestational age (CGA)
Title
Number of hospitalizations
Time Frame
1 year corrected gestational age (CGA)
Title
Length of stay
Description
number of hospital days
Time Frame
about 3 to 7 days

10. Eligibility

Sex
All
Maximum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Candice R Poland, MS, RD, LD
Phone
713-486-6961
Email
Candice.R.Poland@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Candice R Poland, MS, RD, LD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Candice R Poland, MS, RD, LD
Phone
713-486-6961
Email
Candice.R.Poland@uth.tmc.edu

12. IPD Sharing Statement

Learn more about this trial

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

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