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Dietary Supplement

Nutrition Fortification for Preterm Infants (THRIVE Trial)

N/A

Recruiting

Research Sponsored by Children's National Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Postnatal age ≤4 weeks at time of enrollment

Maternal age > 18 years old

Must not have

Dysmorphic features or congenital anomalies suggestive of a genetic syndrome, metabolic disorder, chromosomal abnormality, or congenital infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 60 months (5 years) of age

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare different methods of fortifying human milk for preterm infants to see which one helps them grow better and develop their brains. The current standard method of fortification does not always meet the

Who is the study for?

This trial is for preterm infants with low birth weight, including those born very prematurely. It aims to optimize their growth and brain development by testing different ways of fortifying the milk they receive.

What is being tested?

The study compares three methods of human milk fortification: standardized (the usual way), adjustable (based on protein needs), and targeted (customized to the milk's nutrients). Infants will be randomly assigned to one method until they reach term age or go home.

What are the potential side effects?

While specific side effects are not detailed, all fortification methods aim to be safe for infants. The focus is on improving growth without causing harm, monitored through advanced brain imaging and long-term developmental follow-up.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My baby is 4 weeks old or younger.

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I am over 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have physical features or birth defects that suggest a genetic condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 60 months (5 years) of age

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~60 months (5 years) of age

This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 months (5 years) of age for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Differential Abilities Scale (2nd edition)-(DAS-II)

Head Circumference Growth Velocity

Length Growth Velocity

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: TargetedExperimental Treatment2 Interventions

Targeted fortification will begin 1 week after tolerating goal feeds of standardized fortification. Additional supplementation with liquid protein and/or MCT oil will be provided based on twice weekly milk analysis using a mid-infrared human milk analyzer in order to meet macronutrient (carbohydrate, protein, lipid) and energy intake goals per pediatric nutrition guidelines (protein 4-4.5g/kg/day, fat 6-8g/kg/day, energy 120-130kcal/kg/day). Growth failure is defined as a decline in weight-for-age z-score by \>1 SD beginning 1 week after receiving macronutrient and energy intake within goal range from targeted fortification. For infants with growth failure, total energy intake will be increased with additional protein and/or MCT oil supplementation. Energy intake may be increased weekly as needed.

Group II: AdjustableExperimental Treatment2 Interventions

Adjustable fortification will begin 1 week after tolerating goal feeds of standardized fortification. Blood urea nitrogen (BUN) level as a marker of protein metabolism will be measured weekly, and supplementation with liquid protein will be adjusted as necessary to maintain a goal BUN level between 9-14mmol/dL, up to a maximum assumed protein intake of 4.5 g/kg/day. Liquid protein supplementation will be modified as follows: * BUN Level \<9 mmol/dL: Increase by 0.5g/kg/day * BUN Level 9-14 mmol/dL: No change * BUN Level \>14 mmol/dL: Decrease by 0.25g/kg/day * BUN Level \>20 mmol/dL: Hold for 1 week and re-assess Growth failure is defined as a decline in weight-for-age z-score by \>1 SD beginning 1 week after achieving BUN within goal range from adjustable fortification. For infants who demonstrate growth failure, MCT oil will be added and increased weekly as needed.

Group III: Standardized FortificationActive Control1 Intervention

All study participants will undergo feed advancement and fortification with liquid, bovine-based human milk fortifier (HMF) to an assumed human milk content of 24kcal/oz per the Children's National Hospital NICU standardized clinical feeding protocol. The same milk fortification recipes are utilized for mother's own milk (MOM) and donor human milk (DHM). Each infant's growth trajectory is monitored (weight, length, and head circumference) with dietary modifications performed as needed based on growth parameters. Growth failure is defined as a decline in weight-for-age z-score by greater than 1 standard deviation (\>1 SD) beginning 1 week after reaching goal fortified feeds. For infants who demonstrate growth failure, Step 1 will be to add medium chain triglyceride (MCT) oil. If growth remains sub-optimal, Step 2 will be to add liquid protein.

0 / 3Eligibility criteria met