PrematurityNCT05675397
Preterm Donor Human Milk Supplementation of Mother's Own Milk in VLBW Infants
A study testing donor human milk in people with Prematurity, run by National and Kapodistrian University of Athens at 2 sites in Greece.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 day to 3 weeks
- Conditions the study is for
- Prematurity
- What is being tested?
- donor human milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesGreece
- Study dates
- 1 Dec 2022to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 3 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Congenital anomalies
- Chromosomal disorders
- Metabolic diseases
- Feeding with formula at any point during the first 3 weeks of life (donor milk period)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Greece2 sites, 2 recruiting
- Recruiting
Neonatal Intensive Care Unit, "Elena Venizelou" General and Maternal Hospital
Athens, 11521
Giannoula Gialeli, MD, +30 2109758491, giannoula.g@gmail.com
Anastasia Kapetanaki, MD, +302132051000, nancykap@icloud.com
- Not yet recruiting
First Department of Pediatrics, National and Kapodistrian University of Athens
Athens, 11527
Tania Siahanidou, MD, PhD, +30 2132013517, siahan@med.uoa.gr
About this study
Official title: Supplementation of Mother's Own Milk With Preterm Donor Human Milk: Impact on Morbidity and Growth in Very Low Birth Weight Infants
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.
Read the detailed description
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.
- Conditions
- Prematurity
- Being tested
- donor human milk
- Keywords
- preterm infants, nutrition, donor milk, breast milk
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
donor human milkDietary 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
| Study group | Role | What they receive |
|---|---|---|
| MOM supplemented with PDM (group A) | Experimental | VLBW Infants fed with mother's own milk (MOM) supplemented with preterm donor milk (PDM) Receives: Dietary Supplement: donor human milk |
| MOM supplemented with TDM (group B) | Active comparator | VLBW infants fed with mother's own milk (MOM) supplemented with term donor milk (TDM) Receives: Dietary Supplement: donor human milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of infants' growth
Infants' weight gain during hospitalization (grams per day) will be assessed and compared between group A and group B.
Measured: 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.
Measured: 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.
Measured: From randomization to discharge, up to 40 weeks of postconceptional age (term equivalent age)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start1 Dec 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PrematurityStudies of the same condition, open and under way.
- More trials run by National and Kapodistrian University of AthensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soultana (Tania) Siahanidou, National and Kapodistrian University of Athens
- Investigators
- George Liosis, MD, PhD, Study chair, Neonatal Intensive Care Unit, "Elena Venizelou" General and Maternal Hospital, Athens, 11521, GreeceGiannoula Gialeli, Principal investigator, Neonatal Intensive Care Unit, "Elena Venizelou" General and Maternal Hospital, Athens, 11521, GreeceTania Siahanidou, Study director, First Department of Pediatrics, School of Medicine, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05675397
- Sponsor's protocol ID
- 6116
- Status last verified
- Dec 2022
- First submitted
- 14 Dec 2022
- Last updated
- 9 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36771273
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supplementation of Mother's Own Milk With Preterm Donor Human Milk: Impact on Morbidity and Growth in Very Low Birth Weight Infants
- ClinicalTrials.gov ID
- NCT05675397
- Acronym / sponsor ID
- 6116
- Conditions
- Prematurity
- Keywords
- preterm infants, nutrition, donor milk, breast milk
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 9 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MOM supplemented with PDM (group A) | Experimental | Dietary Supplement: donor human milkVLBW Infants fed with mother's own milk (MOM) supplemented with preterm donor milk (PDM) |
| MOM supplemented with TDM (group B) | Active comparator | Dietary Supplement: donor human milkVLBW infants fed with mother's own milk (MOM) supplemented with term donor milk (TDM) |
Who may qualify
- Ages
- 1 day to 3 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (4 listed)
- Congenital anomalies
- Chromosomal disorders
- Metabolic diseases
- Feeding with formula at any point during the first 3 weeks of life (donor milk period)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| donor human milkPasteurized 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 | Dietary supplement | MOM supplemented with PDM (group A), MOM supplemented with TDM (group B) |
Primary outcome
Assessment of infants' growth
Time frame: From randomization to discharge, up to 40 weeks of postconceptional age (term equivalent age)
Infants' weight gain during hospitalization (grams per day) will be assessed and compared between group A and group B.
Assessment of protein intake
Time frame: From randomization to discharge, up to 40 weeks of postconceptional age (term equivalent age)
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.
Assessment of morbidity
Time frame: From randomization to discharge, up to 40 weeks of postconceptional age (term equivalent age)
Culture positive sepsis in study participants during hospitalization will be assessed and compared between group A and group B.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2023.
- Derived from this study: PubMed 36771273Gialeli 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.
- Individual participant dataSharing planned: No
Related trials for Prematurity
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
George Liosis, MD, PhD study chair
Neonatal Intensive Care Unit, "Elena Venizelou" General and Maternal Hospital, Athens, 11521, Greece
Giannoula Gialeli principal investigator
Neonatal Intensive Care Unit, "Elena Venizelou" General and Maternal Hospital, Athens, 11521, Greece
Tania Siahanidou study director
First Department of Pediatrics, School of Medicine, National and Kapodistrian University of Athens
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing donor human milk in people with Prematurity, run by National and Kapodistrian University of Athens at 2 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tania Siahanidou, MD, PhD (+30 2132013517, siahan@med.uoa.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of infants' growth (time frame: From randomization to discharge, up to 40 weeks of postconceptional age (term equivalent age)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05675397, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2023.