Infant, Very Low Birth WeightPIES-ProjectNCT01809548
Preterm Infants on Early Solid Foods
A study testing Early intervention group and Late intervention group in people with Infant, Very Low Birth Weight and Growth Failure, run by Medical University of Vienna at 1 site in Austria.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 week to 3 months
- Conditions the study is for
- Infant, Very Low Birth Weight, Growth Failure
- What is being tested?
- Early intervention group and Late intervention group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 177 participants
- Where
- 1 siteAustria
- Study dates
- Oct 2013to Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 week to 3 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infants <1500 gram
- Informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Introduction of Solid Foods in Preterm Infants: Effects on Growth, Atopy and Neurodevelopment
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.
Read the detailed description
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.
- Conditions
- Infant, Very Low Birth Weight, Growth Failure
- Being tested
- Early intervention group, Late intervention group
- Keywords
- complementary feeding, premature infant, body composition, atopy, neurodevelopmental outcome, obesity
- Medical subject headings
- Failure to Thrive, Premature Birth, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early intervention groupOther
Also called commercially available solid food
solid food will be introduced between week 10 and 12
Late intervention groupOther
Also called commercially available solid food
solid food is introduced between 16-18th week of gestation corrected for prematurity
| Study group | Role | What they receive |
|---|---|---|
| Early complementary feeding group | Experimental | Early intervention group:
Introduction of early complementary feedings between the 10th -12th week of gestation corrected for prematurity Receives: Other: Early intervention group |
| Late complementary feeding group: | Experimental | Late intervention group:
Introduction of late complementary feedings between the 16th and 18th week of life corrected for prematurity Receives: Other: Late intervention group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 Year
Secondary outcomes (12)
neurodevelopmental outcome
To achieve an improvement of neurodevelopmental outcome assessed by Bayley scales and the K-ABC
Measured: 5 years
IGF-1
To evaluate the risk for later obesity
Measured: 5 years
FX5
To achieve a reduction in risk for atopic diseases
Measured: 5 years
SCORAD
To achieve a reduction in risk for atopic diseases.
Measured: 5 years
Body composition
To achieve an increase of free fat mass (FFM) in body composition measured with the Peapod.
Measured: 5 years
Vitamin D
To achieve a degree of bone mineralization.
Measured: 1 year
Iron status
To achieve the development of anemia
Measured: 1 year
Leptin
To evaluate the risk for later obesity
Measured: 5 years
BMI
to evaluate anthropometric parameters
Measured: 5 years
weight
to evaluate anthropometric parameters
Measured: 5 years
head circumference
to evaluate anthropometric parameters
Measured: 5 years
z-scores
to evaluate anthropometric parameters
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2013 (estimated)
- Study startOct 2013
- Primary completion30 Mar 2020
- Study completionJul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Infant, Very Low Birth WeightStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadja Haiden,MD, Medical University of Vienna
- Investigators
- Nadja Haiden, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01809548
- Sponsor's protocol ID
- PIES001
- Acronym
- PIES-Project
- Status last verified
- Apr 2022
- First submitted
- 1 Mar 2013
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gsoellpointner M, Thanhaeuser M, Kornsteiner-Krenn M, Eibensteiner F, Ristl R, Jilma B, Brandstetter S, Berger A, Haiden N. Nutritional intake and growth in very low birth weight infants: a comparison of standardized versus parent-led complementary feeding. Eur J Clin Nutr. 2026 Aug 8. doi: 10.1038/s41430-026-01809-z. Online ahead of print.
PubMed 42570946Gsoellpointner M, Eibensteiner F, Thanhaeuser M, Ristl R, Jilma B, Berger A, Haiden N. Effects of early introduction of solid foods on nutrient intake in preterm infants during their 1st year of life: a secondary outcome analysis of a prospective, randomized intervention study. Front Nutr. 2023 May 18;10:1124544. doi: 10.3389/fnut.2023.1124544. eCollection 2023.
PubMed 37275631
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Introduction of Solid Foods in Preterm Infants: Effects on Growth, Atopy and Neurodevelopment
- ClinicalTrials.gov ID
- NCT01809548
- Acronym / sponsor ID
- PIES-Project / PIES001
- Conditions
- Infant, Very Low Birth Weight, Growth Failure
- Keywords
- complementary feeding, premature infant, body composition, atopy, neurodevelopmental outcome, obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- Jul 2025 (actual)
- First posted
- 12 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early complementary feeding group | Experimental | Other: Early intervention groupEarly intervention group: Introduction of early complementary feedings between the 10th -12th week of gestation corrected for prematurity |
| Late complementary feeding group: | Experimental | Other: Late intervention groupLate intervention group: Introduction of late complementary feedings between the 16th and 18th week of life corrected for prematurity |
Who may qualify
- Ages
- 1 week to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Preterm infants <1500 gram
- Informed consent
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early intervention groupAlso: commercially available solid foodsolid food will be introduced between week 10 and 12 | Other | Early complementary feeding group |
| Late intervention groupAlso: commercially available solid foodsolid food is introduced between 16-18th week of gestation corrected for prematurity | Other | Late complementary feeding group: |
Primary outcome
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.
12 secondary outcomes
neurodevelopmental outcome
Time frame: 5 years
IGF-1
Time frame: 5 years
FX5
Time frame: 5 years
SCORAD
Time frame: 5 years
Body composition
Time frame: 5 years
Vitamin D
Time frame: 1 year
Iron status
Time frame: 1 year
Leptin
Time frame: 5 years
BMI
Time frame: 5 years
weight
Time frame: 5 years
head circumference
Time frame: 5 years
z-scores
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Derived from this study: PubMed 42570946Gsoellpointner M, Thanhaeuser M, Kornsteiner-Krenn M, Eibensteiner F, Ristl R, Jilma B, Brandstetter S, Berger A, Haiden N. Nutritional intake and growth in very low birth weight infants: a comparison of standardized versus parent-led complementary feeding. Eur J Clin Nutr. 2026 Aug 8. doi: 10.1038/s41430-026-01809-z. Online ahead of print.
- Derived from this study: PubMed 37275631Gsoellpointner M, Eibensteiner F, Thanhaeuser M, Ristl R, Jilma B, Berger A, Haiden N. Effects of early introduction of solid foods on nutrient intake in preterm infants during their 1st year of life: a secondary outcome analysis of a prospective, randomized intervention study. Front Nutr. 2023 May 18;10:1124544. doi: 10.3389/fnut.2023.1124544. eCollection 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nadja Haiden principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early intervention group and Late intervention group in people with Infant, Very Low Birth Weight and Growth Failure, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Height: (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01809548, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.