Premature Birth Clinical Trial
— PROTSUPOfficial title:
Evaluation of Additional Protein Fortification in Extremely Low Birth Weight Infants Fed Human Milk: PROTSUP Study
Verified date | July 2015 |
Source | Hôpital de la Croix-Rousse |
Contact | n/a |
Is FDA regulated | No |
Health authority | France: Committee for the Protection of Personnes |
Study type | Observational |
Postnatal growth is a crucial in premature infants as it could be correlated with the
long-term cognitive development. Optimal nutritional care is required to reduce the initial
weight loss and further growth deficit.
The quantitative objective is to achieve growth that is at least equivalent to that of the
fetus (on average 15 g/kg.day (12-18 g/kg.day according to gestational age). Children often
grow during difficult 10-15 first days of life, so they accumulate a delay that should
compensate them secondarily. Therefore, optimum postnatal growth is rather 20 g/kg.day than
15 g/kg.day.
Individualized fortification of human milk (HM) has been proposed to optimize postnatal
growth. Specifically, the lack of protein intake is responsible for sub-optimal postnatal
growth in preterm infants.
The objectives of this study are to determine the effectiveness of additional protein
fortification (APF) in terms of short-term growth along with the proportion of extremely low
birth weight (ELBW) infants requiring APF.
Status | Completed |
Enrollment | 152 |
Est. completion date | July 2015 |
Est. primary completion date | July 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 4 Months |
Eligibility |
Inclusion Criteria: - infants weighing <1250 g at birth - exclusively fed with fortified HM Exclusion Criteria: - Severe malformations |
Observational Model: Cohort, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hôpital de la Croix-Rousse |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline body weight z-scores to 1 and 2 weeks after additional protein fortification | One and two weeks after the beginning of additional protein fortification | No |
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