Breast Milk CollectionNCT05989009
Analysis of Lipids in Human Milk At Different Gestational Ages
An observational study of Breast Milk Collection, run by Ospedale Buon Consiglio Fatebenefratelli at 2 sites in Italy.
Trial summary
Various studies have shown that the milk of a preterm infant differs from that of a term infant in the composition of micronutrients, vitamins, macronutrients, carbohydrates and proteins. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Breast Milk Collection
- What is being tested?
- Breastfeeding
- How many people
- 66 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Mar 2022to 1 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: They were enrolled mothers that delivered at Buon Consiglio Fatebenefratelli Hospital, Napoli
Who may be able to join
- Mothers who have given birth in hospital at any gestational age
- Written informed consent
- BMI 18.50-24.99 Kg/m2
- Varied and balanced maternal diet without restrictions
- Weight gain during pregnancy up to 12kg
Who cannot join
- Food intolerance
- Celiac disease
- Vegan or vegetarian diet
- Diet with the exclusion of milk and derivatives
- Diagnosis of metabolic diseases
- Taking medicines during pregnancy
- Withdrawal of informed consent
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Department of Woman and Child, Buon Consiglio Fatebenefratelli Hospital
Naples, Napoli, 80123
Department of Pharmacy, University of Salerno
Salerno, Naples, 84084
About this study
Official title: Essential Long-chain Polyunsaturated Fatty Acids Quantitation in Breast Milk Samples At Different Gestational Ages
Various studies have shown that the milk of a preterm infant differs from that of a term infant in the composition of micronutrients, vitamins, macronutrients, carbohydrates and proteins. The study of lipidomic is of particular interest because the role of fatty acids is known both as essential constituents of cell membranes and as molecules actively involved in energy metabolism. The study of human milk would offer the advantage of offering the best type of nutrition for the newborn at each specific period of life, in the event of a lack of mother's milk.
Read the detailed description
Mother's milk is the best food for the newborn as it is the only one capable of providing species-specific nutrition, guaranteeing everything necessary for the growth and maturation of a child. Mother's milk has the property of satisfying metabolic needs by changes in the composition of nutrients, which are different at each stage of life. Various studies have shown that the milk of a preterm infant differs from that of a term infant in the composition of micronutrients, such as vitamins, macronutrients, carbohydrates and proteins. The metabolomic study of human milk would offer the advantage of offering the best type of nutrition for the newborn at each specific period of life, in the event of a lack of mother's milk. This is particularly important in a Neonatal Intensive Care Unit, where it is essential to ensure timely adequate enteral nutrition. This is possible if a bank of donated human milk is available. The study of lipidomics is of particular interest, as the role of fatty acids is known both as essential constituents of cell membranes and as molecules actively involved in energy metabolism. Therefore, the benefit deriving from an adequate dietary intake in a constantly evolving organism such as that of a newborn is extremely important.
- Conditions
- Breast Milk Collection
- Being tested
- Breastfeeding
- Keywords
- newborn, breast milk, fatty acid, gestational age
- Medical subject headings
- Breast Milk Expression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BreastfeedingOther
Mothers will breastfeed their newborns
| Study group | Role | What they receive |
|---|---|---|
| Women < 32 weeks of gestational age | Women that delivered before 32 weeks of gestational age Receives: Other: Breastfeeding | |
| Women between 32 and 36,6 weeks of gestational age | Women that delivered between 32 and 36,6 weeks of gestational age Receives: Other: Breastfeeding | |
| Women > 37 weeks of gestational age | Women that delivered after 37 weeks of gestational age Receives: Other: Breastfeeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of essential long-chain polyunsaturated fatty acids in human milk
To assess the concentrations of α-Linoleic acid (µg/mL) in human milk
Measured: 7 days after delivery
Quantification of essential long-chain polyunsaturated fatty acids in human milk
To assess the concentrations of Eicosapentaenoic acid (µg/mL) in human milk
Measured: 7 days after delivery
Quantification of essential long-chain polyunsaturated fatty acids in human milk
To assess the concentrations of Docosahexaenoic acid (µg/mL) in human milk
Measured: 7 days after delivery
Quantification of essential long-chain polyunsaturated fatty acids in human milk
To assess the concentrations of Arachidonic acid (µg/mL) in human milk
Measured: 7 days after delivery
Quantification of essential long-chain polyunsaturated fatty acids in human milk
To assess the concentrations of Linoleic acid (µg/mL) in human milk
Measured: 7 days after delivery
Secondary outcomes (5)
Quantification of essential long-chain polyunsaturated fatty acids in human milk
To assess the concentrations of α-Linoleic acid (µg/mL) in human milk
Measured: 1 month after delivery
Quantification of essential long-chain polyunsaturated fatty acids in human milk
To assess the concentrations of Eicosapentaenoic acid (µg/mL) in human milk
Measured: 1 month after delivery
Quantification of essential long-chain polyunsaturated fatty acids in human milk
To assess the concentrations of Docosahexaenoic acid (µg/mL) in human milk
Measured: 1 month after delivery
Quantification of essential long-chain polyunsaturated fatty acids in human milk
To assess the concentrations of Arachidonic acid (µg/mL) in human milk
Measured: 1 month after delivery
Quantification of essential long-chain polyunsaturated fatty acids in human milk
To assess the concentrations of Linoleic acid (µg/mL) in human milk
Measured: 1 month after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start1 Mar 2022
- Primary completion1 Oct 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Milk CollectionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale Buon Consiglio Fatebenefratelli
- Sponsor type
- University, hospital or other
- Collaborators
- University of Salerno
- Responsible party
- Principal investigator, Giuseppe De Bernardo, Ospedale Buon Consiglio Fatebenefratelli
- Investigators
- Giuseppe De Bernardo, MD, Principal investigator, Ospedale Buon Consiglio Fatebenefratelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05989009
- Sponsor's protocol ID
- 1669/CE Lazio 1
- Status last verified
- Aug 2023
- First submitted
- 3 Aug 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Essential Long-chain Polyunsaturated Fatty Acids Quantitation in Breast Milk Samples At Different Gestational Ages
- ClinicalTrials.gov ID
- NCT05989009
- Acronym / sponsor ID
- 1669/CE Lazio 1
- Conditions
- Breast Milk Collection
- Keywords
- newborn, breast milk, fatty acid, gestational age
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Ospedale Buon Consiglio FatebenefratelliUniversity, hospital or other
- Collaborators
- University of Salerno
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 14 Aug 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.
Various studies have shown that the milk of a preterm infant differs from that of a term infant in the composition of micronutrients, vitamins, macronutrients, carbohydrates and proteins. The study of lipidomic is of particular interest because the role of fatty acids is known both as essential constituents of cell membranes and as molecules actively involved in energy metabolism. The study of human milk would offer the advantage of offering the best type of nutrition for the newborn at each specific period of life, in the event of a lack of mother's milk.
Detailed description
Mother's milk is the best food for the newborn as it is the only one capable of providing species-specific nutrition, guaranteeing everything necessary for the growth and maturation of a child. Mother's milk has the property of satisfying metabolic needs by changes in the composition of nutrients, which are different at each stage of life. Various studies have shown that the milk of a preterm infant differs from that of a term infant in the composition of micronutrients, such as vitamins, macronutrients, carbohydrates and proteins. The metabolomic study of human milk would offer the advantage of offering the best type of nutrition for the newborn at each specific period of life, in the event of a lack of mother's milk. This is particularly important in a Neonatal Intensive Care Unit, where it is essential to ensure timely adequate enteral nutrition. This is possible if a bank of donated human milk is available. The study of lipidomics is of particular interest, as the role of fatty acids is known both as essential constituents of cell membranes and as molecules actively involved in energy metabolism. Therefore, the benefit deriving from an adequate dietary intake in a constantly evolving organism such as that of a newborn is extremely important.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Women < 32 weeks of gestational age | – | Other: BreastfeedingWomen that delivered before 32 weeks of gestational age |
| Women between 32 and 36,6 weeks of gestational age | – | Other: BreastfeedingWomen that delivered between 32 and 36,6 weeks of gestational age |
| Women > 37 weeks of gestational age | – | Other: BreastfeedingWomen that delivered after 37 weeks of gestational age |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- They were enrolled mothers that delivered at Buon Consiglio Fatebenefratelli Hospital, Napoli
Key inclusion criteria (5 listed)
- Mothers who have given birth in hospital at any gestational age
- Written informed consent
- BMI 18.50-24.99 Kg/m2
- Varied and balanced maternal diet without restrictions
- Weight gain during pregnancy up to 12kg
Key exclusion criteria (7 listed)
- Food intolerance
- Celiac disease
- Vegan or vegetarian diet
- Diet with the exclusion of milk and derivatives
- Diagnosis of metabolic diseases
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 |
|---|---|---|
| BreastfeedingMothers will breastfeed their newborns | Other | Women < 32 weeks of gestational age, Women > 37 weeks of gestational age, Women between 32 and 36,6 weeks of gestational age |
Primary outcome
Quantification of essential long-chain polyunsaturated fatty acids in human milk
Time frame: 7 days after delivery
To assess the concentrations of α-Linoleic acid (µg/mL) in human milk
Quantification of essential long-chain polyunsaturated fatty acids in human milk
Time frame: 7 days after delivery
To assess the concentrations of Eicosapentaenoic acid (µg/mL) in human milk
Quantification of essential long-chain polyunsaturated fatty acids in human milk
Time frame: 7 days after delivery
To assess the concentrations of Docosahexaenoic acid (µg/mL) in human milk
Quantification of essential long-chain polyunsaturated fatty acids in human milk
Time frame: 7 days after delivery
To assess the concentrations of Arachidonic acid (µg/mL) in human milk
Quantification of essential long-chain polyunsaturated fatty acids in human milk
Time frame: 7 days after delivery
To assess the concentrations of Linoleic acid (µg/mL) in human milk
5 secondary outcomes
Quantification of essential long-chain polyunsaturated fatty acids in human milk
Time frame: 1 month after delivery
Quantification of essential long-chain polyunsaturated fatty acids in human milk
Time frame: 1 month after delivery
Quantification of essential long-chain polyunsaturated fatty acids in human milk
Time frame: 1 month after delivery
Quantification of essential long-chain polyunsaturated fatty acids in human milk
Time frame: 1 month after delivery
Quantification of essential long-chain polyunsaturated fatty acids in human milk
Time frame: 1 month after delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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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. This study is not recruiting at the moment.
Giuseppe De Bernardo, MD principal investigator
Ospedale Buon Consiglio Fatebenefratelli
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Milk Collection, run by Ospedale Buon Consiglio Fatebenefratelli at 2 sites in Italy.
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 5 inclusion and 7 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: finished, as of the sponsor's last update on 19 Sep 2024. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification of essential long-chain polyunsaturated fatty acids in human milk (time frame: 7 days after delivery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2024.