Preterm Infants on Early Solid Foods (PIES-Project)
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|ClinicalTrials.gov Identifier: NCT01809548|
Recruitment Status : Active, not recruiting
First Posted : March 12, 2013
Last Update Posted : March 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Infant, Very Low Birth Weight Growth Failure||Other: Early intervention group Other: Late intervention group||Not Applicable|
Aim: In a prospective, randomized, two arm intervention study- the PIES project- we aim to investigate the impact of different time points of introduction of complementary food on growth, body composition, atopic disease and neurodevelopmental outcome in preterm infant with a birth weight <1500 grams. Furthermore, we want to investigate whether a certain standardized feeding protocol meets the nutritional needs of premature infants, and obtain data on safety and efficacy in this context. Methods: At term infants are stratified according to breastfed or formula fed and randomized in one of the following groups: an EARLY complementary feeding group (introduction of complementary food between the 10th and 12th week of life corrected for term, n=76) and LATE complementary feeding group (introduction of complementary food between the 16th and 18th week of life corrected for term, n=76). The infants will be fed with standardized complementary food in addition to formula or breastfeeding until they are one year corrected for prematurity. In an age dependent step up concept, food boxes are delivered to the parents: five types of standardized food boxes with manifold complementary food according to the infants' age and the ability to tolerate small pieces are available for each child during the study. The standardized complementary feeding regimen allows calculating exact intake of nutrients and therefore will provide information concerning primary and secondary outcome. The follow up phase will last until 5 years of age. Within regular visits anthropometric data (height, head circumference, weight, BMI and z-scores ) and body composition via the PeaPod® system will be gathered. Data on atopy will be assessed by clinical scoring system SCORAD (SCORing Atopic Dermatitis) and the laboratory parameters Fx5(Fx5 test uses six food allergens: wheat, egg, cow's milk, soya, peanut and fish) and IgE (immuneglobulineE). Neurodevelopmental outcome will be assessed at the age of one and two years corrected for term by the Bayley Scales and the K-ABC (Kaufman Assessment Battery for Children). The nutritional concept will be monitored concerning short term safety and efficacy (bone metabolism, iron status, protein- and lipid status) as well as regarding long term outcome (diabetes and obesity markers IGF-1 (Insulin-like growth factor-1, adiponectin and leptin).
With the PIES project we intend to close a gap of knowledge in feeding the premature infant during the first year of life and to understand the impact of complementary feeding on growth, atopy, neurodevelopmental outcome and later obesity.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||177 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
After interim analysis switch from prospective randomised to baseline adaptive randomised controlled - stratified according birthweight below /equal 800g and equal/more than 801 grams.
After an interim analysis 1/2019: During the whole study period we had a very low drop out rate of 11% so far. Therefore we adapt the sample size calculation from the anticipated 30% drop out rate to an one-to-one replacement for dropouts + a surplus of 5 patients
|Official Title:||Early Introduction of Solid Foods in Preterm Infants: Effects on Growth, Atopy and Neurodevelopment|
|Study Start Date :||October 2013|
|Estimated Primary Completion Date :||February 28, 2020|
|Estimated Study Completion Date :||December 2024|
Experimental: Early complementary feeding group
Early intervention group:
Introduction of early complementary feedings between the 10th -12th week of gestation corrected for prematurity
Other: Early intervention group
solid food will be introduced between week 10 and 12
Other Name: commercially available solid food
Experimental: Late complementary feeding group:
Late intervention group:
Introduction of late complementary feedings between the 16th and 18th week of life corrected for prematurity
Other: Late intervention group
solid food is introduced between 16-18th week of gestation corrected for prematurity
Other Name: commercially available solid food
- Height: [ Time Frame: 1 Year ]
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.
- neurodevelopmental outcome [ Time Frame: 5 years ]To achieve an improvement of neurodevelopmental outcome assessed by Bayley scales and the K-ABC
- IGF-1 [ Time Frame: 5 years ]To evaluate the risk for later obesity
- FX5 [ Time Frame: 5 years ]To achieve a reduction in risk for atopic diseases
- SCORAD [ Time Frame: 5 years ]To achieve a reduction in risk for atopic diseases.
- Body composition [ Time Frame: 5 years ]To achieve an increase of free fat mass (FFM) in body composition measured with the Peapod.
- Vitamin D [ Time Frame: 1 year ]To achieve a degree of bone mineralization.
- Iron status [ Time Frame: 1 year ]To achieve the development of anemia
- Leptin [ Time Frame: 5 years ]To evaluate the risk for later obesity
- BMI [ Time Frame: 5 years ]to evaluate anthropometric parameters
- weight [ Time Frame: 5 years ]to evaluate anthropometric parameters
- head circumference [ Time Frame: 5 years ]to evaluate anthropometric parameters
- z-scores [ Time Frame: 5 years ]to evaluate anthropometric parameters
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01809548
|Medical University of Vienna|
|Vienna, Austria, 1090|
|Principal Investigator:||Nadja Haiden||Medical University of Vienna|