Infant, Premature, DiseasesADiLLNCT01626508
Prospective Evaluation in Older Premature, Untreated Breast Milk and Milk Processed by the Breast-milk Bank
An observational study of Infant, Premature, Diseases and Fatty Acid Deficiency, run by Centre Hospitalier Universitaire Dijon at 2 sites in France.
Trial summary
The purpose of this study is to evaluate the impact of the enteral nutrition type (untreated breast milk, or breast milk processed by the breast-milk bank) on the longitudinal evolution of the total content and plasma profile of essential fatty acids (EFA) in a population of premature infants. Read more about this study
- Who is it for?
- Ages 1 minute to 12 hours
- Conditions the study is for
- Infant, Premature, Diseases, Fatty Acid Deficiency
- How many people
- 9 participants
- Where
- 2 sitesFrance
- Study dates
- Jun 2012to Jun 2013
- 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 1 minute to 12 hours
- All sexes
- No healthy volunteers
- Child
Study population: for both groups, the gestational age at birth must be less than 33 weeks gestation and at the time of inclusion the child must be hospitalized in neonatal resuscitation
Who may be able to join
- Parent's written informed consent
- Gestational age less than 33 weeks of amenorrhea
- Hospitalisation in an NICU at the time of inclusion
- Intended enteral nutrition with breast milk
Who cannot join
- Persons not covered by the French social security system
- Major congenital malformation
- Participation in other biomedical study protocols
- Babies that are likely to be transferred to another hospital during the study period
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre Hospitalier Universitaire
Dijon, Bourgogne-Franche-Comté, 21000
Centre Hospitalier Regional
Saint-Pierre, LA Reunion, 97448
About this study
Official title: Directed Donation of Untreated Milk or Milk Processed by the Breast-milk : Prospective Evaluation in Older Premature
The purpose of this study is to evaluate the impact of the enteral nutrition type (untreated breast milk, or breast milk processed by the breast-milk bank) on the longitudinal evolution of the total content and plasma profile of essential fatty acids (EFA) in a population of premature infants.
- Conditions
- Infant, Premature, Diseases, Fatty Acid Deficiency
- Keywords
- breast milk, breast-milk bank, plasma profile, essential fatty acids
- Medical subject headings
- Infant, Premature, Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| breast-milk bank | breast milk collected and processed by the breast-milk bank before being used | |
| breast milk | breast milk used without any treatment, directly by children |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the effects of the milk-treatment process at the milk bank on the composition of the milk in terms of FA
- Level of total FA and composition of FA on samples of untreated breast milk immediately after the milk has been expressed
- Level of total FA and composition of FA on samples of breast milk provided by the milk bank just before being given to the infant
Measured: 3 weeks after the establishment of enteral nutrition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, Premature, DiseasesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire Saint Pierre
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01626508
- Sponsor's protocol ID
- IACOBELLI PHRC IR 2011
- Acronym
- ADiLL
- Status last verified
- Feb 2024
- First submitted
- 18 Jun 2012
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Directed Donation of Untreated Milk or Milk Processed by the Breast-milk : Prospective Evaluation in Older Premature
- ClinicalTrials.gov ID
- NCT01626508
- Acronym / sponsor ID
- ADiLL / IACOBELLI PHRC IR 2011
- Conditions
- Infant, Premature, Diseases, Fatty Acid Deficiency
- Keywords
- breast milk, breast-milk bank, plasma profile, essential fatty acids
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire Saint Pierre
- Study start
- Jun 2012 (actual)
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 22 Jun 2012 (estimated)
- 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.
The purpose of this study is to evaluate the impact of the enteral nutrition type (untreated breast milk, or breast milk processed by the breast-milk bank) on the longitudinal evolution of the total content and plasma profile of essential fatty acids (EFA) in a population of premature infants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| breast-milk bank | – | –breast milk collected and processed by the breast-milk bank before being used |
| breast milk | – | –breast milk used without any treatment, directly by children |
Who may qualify
- Ages
- 1 minute to 12 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- for both groups, the gestational age at birth must be less than 33 weeks gestation and at the time of inclusion the child must be hospitalized in neonatal resuscitation
Key inclusion criteria (4 listed)
- Parent's written informed consent
- Gestational age less than 33 weeks of amenorrhea
- Hospitalisation in an NICU at the time of inclusion
- Intended enteral nutrition with breast milk
Key exclusion criteria (4 listed)
- Persons not covered by the French social security system
- Major congenital malformation
- Participation in other biomedical study protocols
- Babies that are likely to be transferred to another hospital during the study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measurement of the effects of the milk-treatment process at the milk bank on the composition of the milk in terms of FA
Time frame: 3 weeks after the establishment of enteral nutrition
* Level of total FA and composition of FA on samples of untreated breast milk immediately after the milk has been expressed * Level of total FA and composition of FA on samples of breast milk provided by the milk bank just before being given to the infant
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 28 Feb 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Infant, Premature, Diseases and Fatty Acid Deficiency, run by Centre Hospitalier Universitaire Dijon at 2 sites in France.
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 4 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: finished, as of the sponsor's last update on 28 Feb 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 France. 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?
Measurement of the effects of the milk-treatment process at the milk bank on the composition of the milk in terms of FA (time frame: 3 weeks after the establishment of enteral nutrition). 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 28 Feb 2024.