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This prospective randomized controlled trial aims to investigate whether feeding very low birth weight (VLBW) infants with Mother's own milk (MOM) supplemented with either preterm (PDM) or term donor milk (TDM), when MOM is insufficient, has a positive impact on infants' protein intake, growth and morbidity.
Mother's own milk (MOM) is the optimal nutrition for preterm infants. When MOM is not sufficient, pasteurized donor milk (DM) is the best alternative according to current recommendations. Donor milk is primarily derived from mothers of term-born infants for the first six months of lactation. However, this term milk presents significant differences compared to preterm human milk which has higher protein concentration and more caloric energy.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MOM supplemented with PDM (group A) | Experimental | VLBW Infants fed with mother's own milk (MOM) supplemented with preterm donor milk (PDM) |
|
| MOM supplemented with TDM (group B) | Active Comparator | VLBW infants fed with mother's own milk (MOM) supplemented with term donor milk (TDM) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| donor human milk | Dietary Supplement | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of infants' growth | Infants' weight gain during hospitalization (grams per day) will be assessed and compared between group A and group B. | From randomization to discharge, up to 40 weeks of postconceptional age (term equivalent age) |
| Assessment of protein intake | Protein intake by the study participants during hospitalization (grams per Kg of body weight per day) will be assessed and compared between group A and group B. | From randomization to discharge, up to 40 weeks of postconceptional age (term equivalent age) |
| Assessment of morbidity | Culture positive sepsis in study participants during hospitalization will be assessed and compared between group A and group B. | From randomization to discharge, up to 40 weeks of postconceptional age (term equivalent age) |
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Inclusion Criteria:
• VLBW infants with birth weight <1500g born to mothers who agree to provide donor milk for the first three weeks of life (donor milk period) if their own milk quantity is insufficient
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tania Siahanidou, MD, PhD | Contact | +30 2132013517 | siahan@med.uoa.gr | |
| Giannoula Gialeli, MD | Contact | +30 2109758491 | giannoula.g@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| George Liosis, MD, PhD | Neonatal Intensive Care Unit, "Elena Venizelou" General and Maternal Hospital, Athens, 11521, Greece | Study Chair |
| Giannoula Gialeli | Neonatal Intensive Care Unit, "Elena Venizelou" General and Maternal Hospital, Athens, 11521, Greece |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neonatal Intensive Care Unit, "Elena Venizelou" General and Maternal Hospital | Recruiting | Athens | 11521 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36771273 | Derived | 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. |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Tania Siahanidou | First Department of Pediatrics, School of Medicine, National and Kapodistrian University of Athens | Study Director |
| First Department of Pediatrics, National and Kapodistrian University of Athens | Not yet recruiting | Athens | 11527 | Greece |
|
| D000091642 | Urogenital Diseases |