Weight Gain in Extremely Premature Infant With Targeted Versus Adjusted Fortification

Not Applicable

Completed

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

• Registration Number: NCT04982133
• Lead Sponsor: Hospital Universitario La Paz

Brief 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.

Detailed Description

1. Study design This is an interventional, randomized, controlled study.

2. Description of the study The very premature newborn will be identified by daily evaluation of the infants admitted for consultation in the income book.

Informed consent will be requested from the infant´s father, mother or legal guardian between the fifth and tenth day of life.

Fortification will be done according to the randomization group.

3. Outline of the study design

* Excel calculation sheet of individualized supplementation according to the composition of breast milk in the target fortification group. Methodology of analysis of breast milk in FOSS analyzer.

* In the adjusted fortification group, urea concentration levels will be kept between 19-30 mg / dL

* Fenton curves or https://www.growthcalculator.org/ will be used for Z-scores calculation.

* Growth speed calculation: Weight gain: (1000x ln \[Final weight / Initial weight\]) / number of days.

4 Duration of the study for each participant The duration of participation in the study and the fortification intervention period will be a maximum of 132 days.

Study Timeline

• Study Start: 2021-04-19
• Study First Submitted: 2021-07-05
• Study First Submitted QC: 2021-07-19
• Study First Posted: 2021-07-29
• Primary Completion: 2022-04-30
• Study Completion: 2023-04-30
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-20
• Last Update Posted: 2024-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

1. Preterm infants born <1000 g of birth weight that are fed with breast milk or donated milk.
2. Written informed consent signed by the mother, father or legal guardian.
3. To tolerate enteral feeding, at least 100mL / kg / day.

Exclusion Criteria

1. Non-premature or premature patients weighing ≥ 1000 gr.
2. Patients with major malformations.
3. Patients with diagnosed chromosomal diseases or of high diagnostic suspicion.
4. Patients with short bowel syndrome or any surgery on the gastrointestinal tract.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Growth rate 28 days after the start of fortification and birth	28 days	To investigate the effect on weight gain during admission of individualized fortification, according to milk analysis, versus fortification adjusted according to urea level.

Secondary Outcome Measures

Name	Time	Method
Mineralization differences between both fortication methods	Until 36 weeks of postmenstrual age (EPM) or at discharge	Difference in phosphate and alkaline phosphatase values

Trial Locations

Locations (1)

University Hospital La Paz; 🇪🇸 Madrid, Spain