LACTACOL 01 - Impact of Breast Milk on the Neurodevelopment of Preterm Newborns
This study is currently recruiting participants.
Verified November 2011 by Nantes University Hospital
Sponsor:
Nantes University Hospital
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01493063
First received: December 13, 2011
Last updated: December 14, 2011
Last verified: November 2011
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Purpose
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.
| Condition |
|---|
|
Prematurity of Fetus |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | BRD/11/02-Y "LACTACOL 01 - Impact of Breast Milk on the Neurodevelopment of Preterm Newborns". |
Further study details as provided by Nantes University Hospital:
Eligibility| Ages Eligible for Study: | 28 Weeks to 34 Weeks |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Preterm newborn
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01493063
Locations
| France | |
| University Hospital of Nantes | Recruiting |
| Nantes, France | |
| Contact: Cécile BOSCHER, Doctor +33 2 40 08 76 80 cecile.boscher@chu-nantes.fr | |
| Principal Investigator: Cécile Boscher, Doctor | |
Sponsors and Collaborators
Nantes University Hospital
Investigators
| Principal Investigator: | Cécile Boscher, Doctor | CHU Nantes |
More Information
No publications provided
| Responsible Party: | Nantes University Hospital |
| ClinicalTrials.gov Identifier: | NCT01493063 History of Changes |
| Other Study ID Numbers: | 11/02-Y |
| Study First Received: | December 13, 2011 |
| Last Updated: | December 14, 2011 |
| Health Authority: | France: Committee for the Protection of Personnes |
Keywords provided by Nantes University Hospital:
|
preterm newborns |
ClinicalTrials.gov processed this record on May 22, 2013