Infant, Very Low Birth Weight Clinical Trial
— PIES-ProjectOfficial title:
Early Introduction of Solid Foods in Preterm Infants: Effects on Growth, Atopy and Neurodevelopment
Verified date | April 2022 |
Source | Medical University of Vienna |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Introduction: Preterm infants with a birth weight less than 1500 grams have special nutritional needs in comparison to full-term neonates. During their stay in the neonatal intensive care unit an increased supply with energy, protein and electrolytes is necessary to establish adequate growth. After discharge from the hospital special breast milk supplements or post discharge formulas are available to cover the special nutrient requirements. Complementary feeding in preterm infants is an unexplored field so far and nutritional concepts for the first year of life are not available. Data concerning the optimal time for starting solid foods are missing as well as information concerning the ideal composition of complementary food. In this context it is essential to meet the special nutritional needs of "Ex-Preemies" on the one hand and avoid overfeeding and later obesity on the other hand. So far it remains unclear, what the "safe" time point for introduction of solid food to premature infants is and whether this time point influences growth, body composition, neurodevelopmental outcome or the incidence of atopic disease.
Status | Active, not recruiting |
Enrollment | 177 |
Est. completion date | December 2024 |
Est. primary completion date | March 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 3 Months |
Eligibility | Inclusion Criteria: - Preterm infants <1500 gram - Informed consent Exclusion Criteria: Diseases affecting stable growth: - Gastrointestinal diseases: necrotizing enterocolitis, Hirschsprung disease, chronic inflammatory bowel disease - Bronchopulmonary dysplasia (BPD) defined as oxygen demand above 36 week gestational age - Congenital heart diseases - major congenital birth defects - chromosomal aberrations |
Country | Name | City | State |
---|---|---|---|
Austria | Medical University of Vienna | Vienna |
Lead Sponsor | Collaborator |
---|---|
Medical University of Vienna |
Austria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Height: | To investigate whether a height difference of 5% at one year of age, corrected for prematurity, can be achieved between the early and the late intervention group.
Height will be measured under standardized conditions in centimeter (cm) at defined times during the first year of life until one year of age corrected for prematurity. Measurements will be done before, within and after intervention in order to demonstrate the changes due to all intervention tools. |
1 Year | |
Secondary | neurodevelopmental outcome | To achieve an improvement of neurodevelopmental outcome assessed by Bayley scales and the K-ABC | 5 years | |
Secondary | IGF-1 | To evaluate the risk for later obesity | 5 years | |
Secondary | FX5 | To achieve a reduction in risk for atopic diseases | 5 years | |
Secondary | SCORAD | To achieve a reduction in risk for atopic diseases. | 5 years | |
Secondary | Body composition | To achieve an increase of free fat mass (FFM) in body composition measured with the Peapod. | 5 years | |
Secondary | Vitamin D | To achieve a degree of bone mineralization. | 1 year | |
Secondary | Iron status | To achieve the development of anemia | 1 year | |
Secondary | Leptin | To evaluate the risk for later obesity | 5 years | |
Secondary | BMI | to evaluate anthropometric parameters | 5 years | |
Secondary | weight | to evaluate anthropometric parameters | 5 years | |
Secondary | head circumference | to evaluate anthropometric parameters | 5 years | |
Secondary | z-scores | to evaluate anthropometric parameters | 5 years |
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