Weight Gain in Extremely Premature Infant With Targeted Versus Adjusted Fortification

NCT04982133 | Completed DMC

• 1 other identifier: HULP5704
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

preterm; nutrition; human milk fortified

Outcome Measures

Primary Outcomes (1)

• Growth rate 28 days after the start of fortification and birth

  To investigate the effect on weight gain during admission of individualized fortification, according to milk analysis, versus fortification adjusted according to urea level.

  28 days

Secondary Outcomes (1)

• Mineralization differences between both fortication methods

  Until 36 weeks of postmenstrual age (EPM) or at discharge

Study Arms (2)

Fortification adjusted according to urea

ACTIVE COMPARATOR

Fortification adjusted according to urea with FM 85 at 4% and oligopeptides. In this arm, fortification at 4% is started, and according to plasma urea control every 15 days the fortification is modified.

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

Individualized fortification according to the nutritional characteristics of breast milk

EXPERIMENTAL

Individualized fortification according to the nutritional characteristics of the mother's own milk or pasteurized milk taken by the premature infant. In this arm, fortification is adjusted based on the macronutrient analysis of breast milk or donated twice weekly.

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

Interventions

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

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.

Also known as: Macronutrient supplementation based on human milk analysis

Fortification adjusted according to urea; Individualized fortification according to the nutritional characteristics of breast milk

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Universitario La Paz: lead

Study Sites (1)

University Hospital La Paz

Madrid, 28046, Spain

Location

MeSH Terms

Conditions

Premature Birth; Breast Feeding

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Feeding Behavior; Behavior

Study Officials

• MARTA CABRERA

  La Paz University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-investigator

Study Record Dates

• First Submitted: July 5, 2021
• First Posted: July 29, 2021
• Study Start: April 19, 2021
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2023
• Last Updated: January 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be available 3 months to 5 years after publication of the article.
• Access Criteria: Researchers submitting a methodologically sound proposal should contact miguel.saenz@salud.madrid.org. In order to access, requesters will need to sign a data access agreement.

Locations

ES (1)