Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03522558
Other study ID # HSC-MS-18-0276
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT04448041 - CRANE Feasibility Study: Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries
Completed NCT03268902 - Early Life Interventions for Childhood Growth and Development In Tanzania Phase 2/Phase 3
Active, not recruiting NCT04746664 - Effects of Nutrition Counselling on Old Age People's Nutritional Status and Quality of Life in Bahir Dar City, North West Ethiopia N/A
Completed NCT04608656 - Livestock for Health Project N/A
Completed NCT06009198 - Nutritional, and WASH Related Education Intervention to Address Malnutrition of Early Adolescents in Pakistan N/A
Recruiting NCT05417672 - Assessment of Relationship Between Preoperative Nutritional Status and Perioperative/Postoperative Conditions in Patients With Lung Cancer Scheduled for Lobectomy
Recruiting NCT05257980 - Evaluation of Four New Ready to Drink Oral Nutritional Supplements: Adult ONS Trial N/A
Completed NCT05015647 - Low Protein Diet in CKD Patients at Risk of Malnutrition N/A
Completed NCT03628196 - A Nutrition-Focused QIP in Outpatient Clinics
Enrolling by invitation NCT04675229 - Extending the Validation of SCREEN to Persons Living With Dementia or in Retirement Homes
Recruiting NCT04627376 - Multimodal Program for Cancer Related Cachexia Prevention N/A
Not yet recruiting NCT06047054 - Incidence Rate and Risk Factors of Malnutrition in ICU
Not yet recruiting NCT05860556 - Sustainable Eating Pattern to Limit Malnutrition in Older Adults
Not yet recruiting NCT04398836 - Preoperative Nutrition for Crohn's Disease Patients Phase 3
Not yet recruiting NCT04183075 - Impact of a Nutritional Supplement on the Recovery of the Nutritional Status of Patients With Spontaneous Hip Fracture N/A
Not yet recruiting NCT03150927 - Clinical Study of Novel Probiotic Microbial Compositeā„¢ to Treat Undernourished Young Children N/A
Recruiting NCT03408067 - Evaluation of the Efficacy of Nutritional Risk Screening Tests, NRS 2002 and SGA, to Identifying Malnourished Patients N/A
Recruiting NCT02833740 - Comparing Performance of Simplified Mid-Upper Arm Circumference Devices ("Click-MUACs") to Detect Acute Malnutrition N/A
Completed NCT02938247 - Tolerance and Compliance of a High Caloric, High Protein Oral Nutritional Supplement - Scheduled Intake N/A
Completed NCT02938234 - Tolerance and Compliance of a High Caloric, High Protein Oral Nutritional Supplement - Free Intake N/A