Prematurity of FetusNCT01493063
LACTACOL 01 - Impact of Breast Milk on the Neurodevelopment of Preterm Newborns
An observational study of Prematurity of Fetus, run by Nantes University Hospital at 1 site in France.
Trial summary
The aim of the study is to estimate the impact of the protein content of breastmilk at the end of hospitalization of the preterm newborn, on the neurodevelopment at 2 years old. The investigators expect a difference of at least 5 points of Development Quotient (DQ) when comparing extreme terciles of the protein… Read more about this study
- Who is it for?
- Ages 28 to 34 weeks
- Conditions the study is for
- Prematurity of Fetus
- What is being tested?
- Physiopathology
- How many people
- 160 participants
- Where
- 1 siteFrance
- Study dates
- 25 Oct 2011to Sep 2025
- 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 28 to 34 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Preterm newborn
Who may be able to join
- Maternal decision of breastfeeding
- Born between 28 and 34 weeks of amenorrhea
- No important congenital pathology except prematurity
- Efficiency of the breastfeeding compatible with the research by the investigator
- Information and authorization of the parents or the parental authority
Who cannot join
- Maternal decision of not breastfeeding
- Born before 28 weeks of amenorrhoea or after or at 34 weeks of amenorrhoea
- Important congenital pathology
- Efficiency of the breastfeeding incompatible with the research by the investigator
- Opposition from parents or the parental authority to participate to the research study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: BRD/11/02-Y "LACTACOL 01 - Impact of Breast Milk on the Neurodevelopment of Preterm Newborns".
The aim of the study is to estimate the impact of the protein content of breastmilk at the end of hospitalization of the preterm newborn, on the neurodevelopment at 2 years old.
The investigators expect a difference of at least 5 points of Development Quotient (DQ) when comparing extreme terciles of the protein content of breastmilk at the end of hospitalization.
- Conditions
- Prematurity of Fetus
- Being tested
- Physiopathology
- Keywords
- preterm infant
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhysiopathologyOther
Samples of breastmilk and infant serum and questionnaires.
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the impact of the protein content of human milk on the neuro-motor development of the preterm infant at 2 years of age
ASQ (Ages and Stages Questionnaires) score at 2 years of age. The calculation of the sample size is only based on this endpoint. We wish to highlight a difference of at least 25 points of the ASQ score between both extreme terciles of protein concentration determined in breast milk at the end of hospitalization, when breastfeeding is exclusive (last sample of breastmilk before the end of hospitalization).
Measured: At 2 years of age
Secondary outcomes (10)
To assess the impact of the protein content of human milk on the Body composition (% fat/lean mass)
Body composition (% fat/lean mass)
Measured: At 2 years of age and at 7-8 years of age
To assess the impact of the protein content of human milk on feeding behavior
Dietary behavior
Measured: At 2 years of age and at 7-8 years of age
To assess the impact of the protein content of human milk on growth trajectory and metabolic status of the preterm infant
Staturo-weight growth rate
Measured: At 2 years of age and at 7-8 years of age
To assess the impact of the protein content of human milk on the coginitive intelligence of the preterm infant
Standardized and validated test WISC V
Measured: At 7-8 years of age
To assess the impact of the protein content of human milk on the executive functioning of the preterm infant
Standardized and validated test FEE
Measured: At 7-8 years of age
To assess the impact of the protein content of human milk on the executive dysfunction of the preterm infant
Standardized and validated test BRIEF battery
Measured: At 7-8 years of age
To assess the impact of the protein content of human milk on the child's behaviour in the classroom of the preterm infant
Standardized and validated test GSA
Measured: At 7-8 years of age
To assess the impact of the protein content of human milk on the generalist clinical evaluation of the preterm infant
Standardized and validated test BMT-i
Measured: At 7-8 years of age
To assess the impact of the protein content of human milk on the physical activity of the preterm infant
Actimeter (ACTIGRAPH®)
Measured: At 7-8 years of age
To assess the impact of the protein content of human milk on the physical activity of the preterm infant
ESTEBAN questionnaire (Santé Publique France).
Measured: At 7-8 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2011 (estimated)
- Study start25 Oct 2011
- Primary completionApr 2018
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prematurity of FetusStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cécile Boscher, Doctor, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01493063
- Sponsor's protocol ID
- BRD/11/02-Y
- Status last verified
- May 2023
- First submitted
- 13 Dec 2011
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Boquien CY, Billard H, Simon L, Boscher C, Legrand A, Joram E, Moyon T, Alexandre-Gouabau MC, Darmaun D, Roze JC. Breast milk protein content at week 3 after birth and neurodevelopmental outcome in preterm infants fed fortified breast milk. Eur J Nutr. 2021 Oct;60(7):3959-3969. doi: 10.1007/s00394-021-02562-8. Epub 2021 Apr 30.
PubMed 33929587Alexandre-Gouabau MC, Moyon T, Douarec C, Moulazem Y, Croyal M, Gourdel M, Roze JC, Simon L, Boscher C, Billard H, David-Sochard A, Reze S, Misery B, Bizec BL, Guillou S, Antignac JP, Boquien CY, Vigneau E, Mahieu B, Cano-Sancho G. An exploration of the breast milk nutriome, exposome and microbiome and their links to early growth in preterm infants. J Nutr Biochem. 2026 May;151:110268. doi: 10.1016/j.jnutbio.2026.110268. Epub 2026 Jan 14.
PubMed 41544718
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BRD/11/02-Y "LACTACOL 01 - Impact of Breast Milk on the Neurodevelopment of Preterm Newborns".
- ClinicalTrials.gov ID
- NCT01493063
- Acronym / sponsor ID
- BRD/11/02-Y
- Conditions
- Prematurity of Fetus
- Keywords
- preterm infant
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 25 Oct 2011 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Sep 2025 (estimated)
- First posted
- 15 Dec 2011 (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 aim of the study is to estimate the impact of the protein content of breastmilk at the end of hospitalization of the preterm newborn, on the neurodevelopment at 2 years old.
The investigators expect a difference of at least 5 points of Development Quotient (DQ) when comparing extreme terciles of the protein content of breastmilk at the end of hospitalization.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 28 to 34 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Preterm newborn
Key inclusion criteria (5 listed)
- Maternal decision of breastfeeding
- Born between 28 and 34 weeks of amenorrhea
- No important congenital pathology except prematurity
- Efficiency of the breastfeeding compatible with the research by the investigator
- Information and authorization of the parents or the parental authority
Key exclusion criteria (5 listed)
- Maternal decision of not breastfeeding
- Born before 28 weeks of amenorrhoea or after or at 34 weeks of amenorrhoea
- Important congenital pathology
- Efficiency of the breastfeeding incompatible with the research by the investigator
- Opposition from parents or the parental authority to participate to the research study
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 |
|---|---|---|
| PhysiopathologySamples of breastmilk and infant serum and questionnaires. | Other | – |
Primary outcome
To assess the impact of the protein content of human milk on the neuro-motor development of the preterm infant at 2 years of age
Time frame: At 2 years of age
ASQ (Ages and Stages Questionnaires) score at 2 years of age. The calculation of the sample size is only based on this endpoint. We wish to highlight a difference of at least 25 points of the ASQ score between both extreme terciles of protein concentration determined in breast milk at the end of hospitalization, when breastfeeding is exclusive (last sample of breastmilk before the end of hospitalization).
10 secondary outcomes
To assess the impact of the protein content of human milk on the Body composition (% fat/lean mass)
Time frame: At 2 years of age and at 7-8 years of age
To assess the impact of the protein content of human milk on feeding behavior
Time frame: At 2 years of age and at 7-8 years of age
To assess the impact of the protein content of human milk on growth trajectory and metabolic status of the preterm infant
Time frame: At 2 years of age and at 7-8 years of age
To assess the impact of the protein content of human milk on the coginitive intelligence of the preterm infant
Time frame: At 7-8 years of age
To assess the impact of the protein content of human milk on the executive functioning of the preterm infant
Time frame: At 7-8 years of age
To assess the impact of the protein content of human milk on the executive dysfunction of the preterm infant
Time frame: At 7-8 years of age
To assess the impact of the protein content of human milk on the child's behaviour in the classroom of the preterm infant
Time frame: At 7-8 years of age
To assess the impact of the protein content of human milk on the generalist clinical evaluation of the preterm infant
Time frame: At 7-8 years of age
To assess the impact of the protein content of human milk on the physical activity of the preterm infant
Time frame: At 7-8 years of age
To assess the impact of the protein content of human milk on the physical activity of the preterm infant
Time frame: At 7-8 years of age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Background: PubMed 33929587Boquien CY, Billard H, Simon L, Boscher C, Legrand A, Joram E, Moyon T, Alexandre-Gouabau MC, Darmaun D, Roze JC. Breast milk protein content at week 3 after birth and neurodevelopmental outcome in preterm infants fed fortified breast milk. Eur J Nutr. 2021 Oct;60(7):3959-3969. doi: 10.1007/s00394-021-02562-8. Epub 2021 Apr 30.
- Derived from this study: PubMed 41544718Alexandre-Gouabau MC, Moyon T, Douarec C, Moulazem Y, Croyal M, Gourdel M, Roze JC, Simon L, Boscher C, Billard H, David-Sochard A, Reze S, Misery B, Bizec BL, Guillou S, Antignac JP, Boquien CY, Vigneau E, Mahieu B, Cano-Sancho G. An exploration of the breast milk nutriome, exposome and microbiome and their links to early growth in preterm infants. J Nutr Biochem. 2026 May;151:110268. doi: 10.1016/j.jnutbio.2026.110268. Epub 2026 Jan 14.
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Amniotic Fluid & the Preterm Gut
Chorioamnionitis, Chorioamnionitis Affecting Fetus or Newborn
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.
Cécile Boscher, Doctor principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prematurity of Fetus, run by Nantes University Hospital at 1 site 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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
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?
To assess the impact of the protein content of human milk on the neuro-motor development of the preterm infant at 2 years of age (time frame: At 2 years of age). 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 NCT01493063, which also lists 2 linked publications.
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 10 May 2023; AzTrials last refreshed its copy on 8 Nov 2026.