Analysis of Lipids in Human Milk At Different Gestational Ages (NCT05989009) | Clinical Trial Compass
CompletedNot Applicable
Analysis of Lipids in Human Milk At Different Gestational Ages
Italy66 participantsStarted 2022-03-01
Plain-language 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. 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Quantification of essential long-chain polyunsaturated fatty acids in human milk
Timeframe: 7 days after delivery
2
Quantification of essential long-chain polyunsaturated fatty acids in human milk
Timeframe: 7 days after delivery
3
Quantification of essential long-chain polyunsaturated fatty acids in human milk
Timeframe: 7 days after delivery
4
Quantification of essential long-chain polyunsaturated fatty acids in human milk
Timeframe: 7 days after delivery
5
Quantification of essential long-chain polyunsaturated fatty acids in human milk