Preterm Donor Human Milk Supplementation of Mother's Own Milk in VLBW Infants
NCT ID: NCT05675397
Last Updated: 2023-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
200 participants
INTERVENTIONAL
2022-12-01
2027-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Transition From Donor Milk: a Feasibility Study
NCT06514014
Enrichment of Human Milk With Human and Bovine Milk-based Fortifiers for Very Preterm Infants: a Meta-analysis
NCT06870318
Donor Milk vs. Formula in Extremely Low Birth Weight (ELBW) Infants
NCT01534481
Target Versus Standard Human Milk Fortification in Very Low Birth Weight Preterm Infants
NCT02716337
Effect of Extensively Hydrolyzed Liquid Human Milk Fortifier on Growth and Tolerance in Moderately Premature Infants
NCT02632266
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The investigators hypothesized that feeding VLBW infants with preterm donor milk (PDM) in combination with MOM may positively influence the protein intake and, consequently, the infants' growth. The aim of the current study is to assess whether MOM supplementation with PDM has any beneficial effects on the nutrition, growth and morbidity in VLBW infants.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
MOM supplemented with PDM (group A)
VLBW Infants fed with mother's own milk (MOM) supplemented with preterm donor milk (PDM)
donor human milk
Pasteurized preterm donor milk (PDM) versus term donor milk (TDM) will be provided to the study population following randomization, as supplementary to mother's own milk (MOM) or as alternative feeding
MOM supplemented with TDM (group B)
VLBW infants fed with mother's own milk (MOM) supplemented with term donor milk (TDM)
donor human milk
Pasteurized preterm donor milk (PDM) versus term donor milk (TDM) will be provided to the study population following randomization, as supplementary to mother's own milk (MOM) or as alternative feeding
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
donor human milk
Pasteurized preterm donor milk (PDM) versus term donor milk (TDM) will be provided to the study population following randomization, as supplementary to mother's own milk (MOM) or as alternative feeding
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Chromosomal disorders
* Metabolic diseases
* Feeding with formula at any point during the first 3 weeks of life (donor milk period)
1 Day
3 Weeks
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National and Kapodistrian University of Athens
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Soultana (Tania) Siahanidou
Professor in Pediatrics-Neonatology
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
George Liosis, MD, PhD
Role: STUDY_CHAIR
Neonatal Intensive Care Unit, "Elena Venizelou" General and Maternal Hospital, Athens, 11521, Greece
Giannoula Gialeli
Role: PRINCIPAL_INVESTIGATOR
Neonatal Intensive Care Unit, "Elena Venizelou" General and Maternal Hospital, Athens, 11521, Greece
Tania Siahanidou
Role: STUDY_DIRECTOR
First Department of Pediatrics, School of Medicine, National and Kapodistrian University of Athens
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Neonatal Intensive Care Unit, "Elena Venizelou" General and Maternal Hospital
Athens, , Greece
First Department of Pediatrics, National and Kapodistrian University of Athens
Athens, , Greece
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Gialeli G, Kapetanaki A, Panagopoulou O, Vourna P, Michos A, Kanaka-Gantenbein C, Liosis G, Siahanidou T. Supplementation of Mother's Own Milk with Preterm Donor Human Milk: Impact on Protein Intake and Growth in Very Low Birth Weight Infants-A Randomized Controlled Study. Nutrients. 2023 Jan 21;15(3):566. doi: 10.3390/nu15030566.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
6116
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.