Growth Failure in Medically Complex InfantsNCT03522558
Medical Nutrition Therapy for Medically Complex Infants in the Pediatric Outpatient Setting
A study testing Standardized Medical Nutrition Therapy in people with Growth Failure in Medically Complex Infants and Growth Failure, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 2 yearsHealthy volunteers can take part
- Conditions the study is for
- Growth Failure in Medically Complex Infants, Growth Failure, Malnutrition in Medically Complex Infants
- What is being tested?
- Standardized Medical Nutrition Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2018to 1 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 2 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
Who cannot join
- short bowel syndrome,
- requiring parenteral nutrition (PN)
- active cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Candice R Poland, MS, RD, LD, 713-486-6961, Candice.R.Poland@uth.tmc.edu
About this study
Official title: 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.
- Conditions
- Growth Failure in Medically Complex Infants, Growth Failure, Malnutrition in Medically Complex Infants, Malnutrition, Nutrition in Medically Complex Infants, Nutrition
- Being tested
- Standardized Medical Nutrition Therapy, Usual Care
- Medical subject headings
- Failure to Thrive, Malnutrition, Infant Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized Medical Nutrition TherapyBehavioural
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 CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Standardized Medical Nutrition Therapy | Experimental | 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. Receives: Behavioral: Standardized Medical Nutrition Therapy |
| Usual Care | Active comparator | 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. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with a 20% improvement in growth velocity at 1 year corrected gestational age (CGA)
Measured: 4 months corrected gestational age (CGA)
Number of participants with a 20% improvement in growth velocity at 1 year corrected gestational age (CGA)
Measured: 8 months corrected gestational age (CGA)
Number of participants with a 20% improvement in growth velocity at 1 year corrected gestational age (CGA)
Measured: 12 months corrected gestational age (CGA)
Number of participants with a 20% improvement in growth velocity at 1 year corrected gestational age (CGA)
Measured: 1 year corrected gestational age (CGA)
Secondary outcomes (6)
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.
Measured: 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.
Measured: 1 year corrected gestational age (CGA)
Severity of malnutrition as assessed by the AND/ASPEN criteria
Measured: 1 year corrected gestational age (CGA)
Number of emergency department visits
Measured: 1 year corrected gestational age (CGA)
Number of hospitalizations
Measured: 1 year corrected gestational age (CGA)
Length of stay
number of hospital days
Measured: about 3 to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start1 Jul 2018 (estimated)
- Primary completion1 Jun 2019 (estimated)
- Study completion1 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth Failure in Medically Complex InfantsStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Candice Rachel Poland, The University of Texas Health Science Center, Houston
- Investigators
- Candice R Poland, MS, RD, LD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03522558
- Sponsor's protocol ID
- HSC-MS-18-0276
- Status last verified
- May 2018
- First submitted
- 30 Apr 2018
- Last updated
- 16 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Nutrition Therapy for Medically Complex Infants in the Pediatric Outpatient Setting. A Quality Improvement Project
- ClinicalTrials.gov ID
- NCT03522558
- Acronym / sponsor ID
- HSC-MS-18-0276
- Conditions
- Growth Failure in Medically Complex Infants, Growth Failure, Malnutrition in Medically Complex Infants, Malnutrition, Nutrition in Medically Complex Infants, Nutrition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 1 Jul 2018 (estimated)
- Primary completion
- 1 Jun 2019 (estimated)
- Study completion
- 1 Jun 2019 (estimated)
- First posted
- 11 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standardized Medical Nutrition Therapy | Experimental | Behavioral: Standardized Medical Nutrition TherapyStandardized 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 | Active comparator | Behavioral: Usual CareAt 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. |
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (3 listed)
- short bowel syndrome,
- requiring parenteral nutrition (PN)
- active cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized Medical Nutrition TherapyStandardized 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. | Behavioural | Standardized Medical Nutrition Therapy |
| Usual CareAt 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. | Behavioural | Usual Care |
Primary outcome
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)
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)
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)
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)
6 secondary outcomes
Number of participants with growth failure
Time frame: 1 year corrected gestational age (CGA)
Number of participants who are malnourished
Time frame: 1 year corrected gestational age (CGA)
Severity of malnutrition as assessed by the AND/ASPEN criteria
Time frame: 1 year corrected gestational age (CGA)
Number of emergency department visits
Time frame: 1 year corrected gestational age (CGA)
Number of hospitalizations
Time frame: 1 year corrected gestational age (CGA)
Length of stay
Time frame: about 3 to 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Candice R Poland, MS, RD, LD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized Medical Nutrition Therapy in people with Growth Failure in Medically Complex Infants and Growth Failure, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Candice R Poland, MS, RD, LD (713-486-6961, Candice.R.Poland@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2018.