An interventional study of Early intervention group and Late intervention group in Infant, Very Low Birth Weight and Growth Failure, sponsored by Medical University of Vienna. Completed at 1 site in Austria. Open to participants aged 1 Week to 3 Months. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Medical University of Vienna · Not applicable, Interventional, and Treatment
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.
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.
84 studies on the registry are indexed under Failure to Thrive; 12 are open to participants now.
This study's enrollment of 177 is above the median of 100 across 56 interventional studies indexed under Failure to Thrive.
Browse Failure to Thrive studies →Medical University of Vienna is the lead sponsor of 1,109 studies on the registry; 184 are open to participants now.
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Exclusion Criteria:
Diseases affecting stable growth:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Early intervention group: Introduction of early complementary feedings between the 10th -12th week of gestation corrected for prematurity
Other: Early intervention 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 will be introduced between week 10 and 12
Also known as: commercially available solid food
solid food is introduced between 16-18th week of gestation corrected for prematurity
Also known as: commercially available solid food
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.
Time frame: 1 Year
neurodevelopmental outcome
To achieve an improvement of neurodevelopmental outcome assessed by Bayley scales and the K-ABC
Time frame: 5 years
IGF-1
To evaluate the risk for later obesity
Time frame: 5 years
FX5
To achieve a reduction in risk for atopic diseases
Time frame: 5 years
SCORAD
To achieve a reduction in risk for atopic diseases.
Time frame: 5 years
Body composition
To achieve an increase of free fat mass (FFM) in body composition measured with the Peapod.
Time frame: 5 years
Vitamin D
To achieve a degree of bone mineralization.
Time frame: 1 year
Iron status
To achieve the development of anemia
Time frame: 1 year
Leptin
To evaluate the risk for later obesity
Time frame: 5 years
BMI
to evaluate anthropometric parameters
Time frame: 5 years
weight
to evaluate anthropometric parameters
Time frame: 5 years
head circumference
to evaluate anthropometric parameters
Time frame: 5 years
z-scores
to evaluate anthropometric parameters
Time frame: 5 years
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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