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Weight Gain in Extremely Premature Infant With Targeted Versus Adjusted Fortification

NCT04982133 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2024-01-23

No results posted yet for this study

Summary

Investigation about the effect on weight gain in extremely low birth weight preterm with individualized fortification, according to human milk analysis versus fortification adjusted according to urea serum concentration.

Conditions

  • Preterm
  • Very Low Birth Weight Infant
  • Feeding, Breast
  • Food, Fortified

Interventions

DIETARY_SUPPLEMENT

Protein supplementation based on plasma urea concentration every other week or human milk analysis on experiment

At the time that the doctor decides to start fortification, it will be done according to urea levels in active comparator arm or human milk analysis on experimental group. In Group A, fortification at 4% is started, and according to plasma urea control every 15 days the fortification is modified. In Group B, fortification is adjusted based on the macronutrient analysis of breast or donated milk.

Sponsors & Collaborators

  • Hospital Universitario La Paz

    lead OTHER

Principal Investigators

  • MARTA CABRERA · La Paz University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-19
Primary Completion
2022-04-30
Completion
2023-04-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04982133 on ClinicalTrials.gov