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NCT02372136 · ClinicalTrials.gov registry record · NA

Optimizing Individual Nutrition in Preterm Very Low Birth Weight Infants

A NA study, sponsored by University of Texas Southwestern Medical Center.

Completed
Registry status
NA
Development phase
120
Enrollment target

NCT02372136: Completed NA study, sponsored by University of Texas Southwestern Medical Center.

NCT02372136 is a NA study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 120 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02372136, a NA study, has completed, sponsored by University of Texas Southwestern Medical Center.

COMPLETED
Registry status
NA
Development phase
120 participants
Enrollment target

Study Summary

In preterm infants fed human milk, milk needs to be fortified to meet nutrient recommendations. Fortification can be 1) standard, 2) individualized (adjusted based on daily human milk nutrient analysis and milk volume), or 3) optimized (adjusted based on growth rate and serum analyses). The first specific aim will determine whether individualized and optimized nutrition during hospitalization results in improved growth in the neonatal intensive care unit (NICU) in extremely low gestational age (GA) neonates (ELGANs, \<29 weeks) and in small for GA (SGA, birth weight \<10th percentile for GA) preterm infants compared with optimized nutrition. The second specific aim will determine whether individualized and optimized nutrition in the NICU improves neurodevelopmental outcomes (acquisition of development milestones) and reduces the risk of disproportionate growth (i.e., excess fat) in the NICU and findings suggestive of metabolic syndrome in the first 3 years of life.

Primary Outcome

Rate of weight gain \[g x kg-1 x day-1\] and length velocity \[cm x week-1\]

Interventions

  • DIETARY_SUPPLEMENT Individualized Nutrition
  • DIETARY_SUPPLEMENT Optimized nutrition

Trial Details

FieldValue
Enrollment Target 120 participants
Start Date 2016-01
Est. Completion 2023-12-31
Phase NA

What the finished NCT02372136 record still lists

NCT02372136 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower).

The record links to 0 conditions, and to 2 interventions - of which Individualized Nutrition is the first listed.

NCT02372136 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02372136 about?

NCT02372136 is a clinical study titled "Optimizing Individual Nutrition in Preterm Very Low Birth Weight Infants". In preterm infants fed human milk, milk needs to be fortified to meet nutrient recommendations. Fortification can be 1) standard, 2) individualized (adjusted based on daily human milk nutrient analysis and milk volume), or 3) optimized (adjusted based on growth rate and serum analyses). The first s...

What is the current status of trial NCT02372136?

This trial is currently completed. It is a NA study. The enrollment target is 120 participants. The study started on 2016-01. Estimated completion is 2023-12-31.

What interventions are being tested in trial NCT02372136?

The interventions under investigation include: Individualized Nutrition (DIETARY_SUPPLEMENT), Optimized nutrition (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT02372136?

This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02372136's enrollment target sits among peer trials

120 762nd of 2000 higher than 1,198 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02372136, the US trial registry maintained by the National Library of Medicine. NCT02372136 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.