Growth FailurePREWEANNCT02936219
The PREWEAN Study. Weaning of Preterm Infants During the First Year of Life.
An observational study of Growth Failure and Atopy, run by Medical University of Vienna at 1 site in Austria.
Trial summary
In this Austrian observational study preterm infants born with a birth weight <1500 g and a gestational age <32 weeks will be investigated at the neonatal outpatient clinic. Infants will be stratified according their feeding regimen (breast, formula and combined feeding) and their introduction of solid foods (early… Read more about this study
- Who is it for?
- Ages 1 week to 3 monthsHealthy volunteers can take part
- Conditions the study is for
- Growth Failure, Atopy, Adiposity
- How many people
- 218 participants
- Where
- 1 siteAustria
- Study dates
- Apr 2016to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Child
Study population: Preterm infants born with a birth weight <1500g and a gestational age <32 weeks
Who may be able to join
- Preterm infants born with a birth weight <1500g and a gestational age <32 weeks
- Informed consent
Who cannot join
- Gastrointestinal diseases: e.g. Hirschsprung disease
- Congenital heart diseases
- Major congenital birth defects
- Chromosomal aberrations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Weaning of Preterm Infants During the First Year of Life: Impact on Anthropometry, Body Composition, Atopy and Neurodevelopmental Outcome
In this Austrian observational study preterm infants born with a birth weight <1500 g and a gestational age <32 weeks will be investigated at the neonatal outpatient clinic. Infants will be stratified according their feeding regimen (breast, formula and combined feeding) and their introduction of solid foods (early complementary feeding group: <17th week of life corrected for prematurity, late complementary feeding group: ≥17th week of life corrected for prematurity). Nutrient intakes and anthropometric parameters will be assessed at term, 6 weeks, 12 weeks, 6 months, 9 months and 12 months - all corrected for prematurity and with 40, 54 and 66 months.
Read the detailed description
Introduction: Evidenced-based guidelines for the introduction of complementary feeding in preterm infants are not available so far. In comparison to full-term babies, there is strong evidence that babies less than 1500 grams have increased nutritional needs starting with the time of birth up to the second year of life to establish catch up growth and to reach the main milestones in neurological development.
Evidence based data on feeding practices after discharge of the hospital, weaning and the quantity and quality of complementary food are missing. With this prospective observational study the investigators intend to close this knowledge gap in weaning of former preterm infants.
Methods: In this prospective observational study preterm infants born with a birth weight <1500 g and a gestational age <32 weeks will be recruited at term corrected for prematurity at the neonatal outpatient clinic. Infants will be stratified according their source of milk intake (breast milk, formula and mixed feeding) and their introduction of solid foods (early complementary feeding group: <17th week of life corrected for prematurity, late complementary feeding group: ≥17th week of life corrected for prematurity).
Nutritional intake will be estimated based on 24h Recalls at term and after 6 weeks of age corrected for prematurity. Furthermore, 3-days dietary records, an average dietary record and the introduction of the main food categories will be queried at 4 different time points (3 months, 6 months, 9 months and 12 months - all corrected for prematurity) by food questionnaire.
Within these visits anthropometric parameters (height, head circumference and weight), data on body composition (Pea Pod®, BodPod ) \& bio-impedance measurements will be collected. Atopy will be determined by the clinical scoring system SCORAD. For follow up anthropometry and the neurodevelopmental outcome will be assessed by the Bayley Scale at 12 \& 24 months corrected for prematurity and at 40 months of age. Furthermore, K-ABC II (Kaufmann assessment battery for children) will be performed at 66 months of age.
Goals: With this observational study the investigators aim to identify current feeding practices in premature infants and their impact on growth, body composition, atopy and neurodevelopmental outcome.
- Conditions
- Growth Failure, Atopy, Adiposity, Cognitive Impairment, Neurological Impairment
- Keywords
- complementary feeding, breast milk, formula feeding, combined feeding, preterm infants, body composition
- Medical subject headings
- Failure to Thrive, Obesity, Cognitive Dysfunction, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Early complementary breast feeding | The EARLY complementary feeding group is defined as the introduction of complementary food <17th week of life corrected for term. In addition, infants are stratified to the milk regime, like human milk feeding, at the study enrollment. | |
| Early complementary combined feeding | The EARLY complementary feeding group is defined as the introduction of complementary food <17th week of life corrected for term. In addition, infants are stratified to the milk regime, like combined milk feeding, at the study enrollment. | |
| Early complementary formula feeding | The EARLY complementary feeding group is defined as the introduction of complementary food <17th week of life corrected for term. In addition, infants are stratified to the milk regime, like formula feeding, at the study enrollment. | |
| Late complementary breast feeding | The LATE complementary feeding group is defined as the introduction of complementary food ≥17th week of life corrected for term. In addition, infants are stratified to the milk regime, like human milk feeding, at the study enrollment. | |
| Late complementary combined feeding | The LATE complementary feeding group is defined as the introduction of complementary food ≥17th week of life corrected for term. In addition, infants are stratified to the milk regime, like combined milk feeding, at the study enrollment. | |
| Late complementary formula feeding | The LATE complementary feeding group is defined as the introduction of complementary food ≥17th week of life corrected for term. In addition, infants are stratified to the milk regime, like formula feeding, at the study enrollment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Is there a height difference of 5% at one year of age corrected for prematurity between different complementary feeding groups?
Is there a height difference of 5% at one year of age corrected for prematurity
Measured: The patients will be recruited in the period of 04/2016 till 06/2021. The primary observation period is one year.The follow up period lasts until 06/2025
Secondary outcomes (6)
Atopy
Atopy measured by SCORAD
Measured: 04/2016 till 06/2025
Body composition
Fat free mass measure by the body composition devices Peapod and Bodpod
Measured: 04/2016 till 06/2025
Neurodevelopmental outcome with 1 and 2 years
Neurodevelopmental outcome measured by the Bailey III with 1 and 2 years of age corrected for prematurity
Measured: 04/2017 till 06/2025
Neurodevelopmental outcome with 4,5 and 5,5 years
Neurodevelopmental outcome measured with the KABC- II by 54 and 66 moths of age
Measured: 04/2017 till 06/2025
weight
weight in g or kg
Measured: 04/2016-06/2025
head circumference
in cm
Measured: 04/2016-06/2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2021
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Growth FailureStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- Wilhelminenspital Vienna, Kaiser Franz Josef Hospital
- Responsible party
- Principal investigator, Nadja Haiden,MD, Medical University of Vienna
- Investigators
- Nadja Haiden, Principal investigator, Medical University of Vienna, 1090 Vienna, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02936219
- Sponsor's protocol ID
- PREWEAN
- Acronym
- PREWEAN
- Status last verified
- Apr 2022
- First submitted
- 14 Oct 2016
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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 42570946
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weaning of Preterm Infants During the First Year of Life: Impact on Anthropometry, Body Composition, Atopy and Neurodevelopmental Outcome
- ClinicalTrials.gov ID
- NCT02936219
- Acronym / sponsor ID
- PREWEAN / PREWEAN
- Conditions
- Growth Failure, Atopy, Adiposity, Cognitive Impairment, Neurological Impairment
- Keywords
- complementary feeding, breast milk, formula feeding, combined feeding, preterm infants, body composition
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 218 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- Wilhelminenspital Vienna, Kaiser Franz Josef Hospital
- Study start
- Apr 2016
- Primary completion
- Dec 2021 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 18 Oct 2016 (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.
In this Austrian observational study preterm infants born with a birth weight <1500 g and a gestational age <32 weeks will be investigated at the neonatal outpatient clinic. Infants will be stratified according their feeding regimen (breast, formula and combined feeding) and their introduction of solid foods (early complementary feeding group: <17th week of life corrected for prematurity, late complementary feeding group: ≥17th week of life corrected for prematurity). Nutrient intakes and anthropometric parameters will be assessed at term, 6 weeks, 12 weeks, 6 months, 9 months and 12 months - all corrected for prematurity and with 40, 54 and 66 months.
Detailed description
Introduction: Evidenced-based guidelines for the introduction of complementary feeding in preterm infants are not available so far. In comparison to full-term babies, there is strong evidence that babies less than 1500 grams have increased nutritional needs starting with the time of birth up to the second year of life to establish catch up growth and to reach the main milestones in neurological development.
Evidence based data on feeding practices after discharge of the hospital, weaning and the quantity and quality of complementary food are missing. With this prospective observational study the investigators intend to close this knowledge gap in weaning of former preterm infants.
Methods: In this prospective observational study preterm infants born with a birth weight <1500 g and a gestational age <32 weeks will be recruited at term corrected for prematurity at the neonatal outpatient clinic. Infants will be stratified according their source of milk intake (breast milk, formula and mixed feeding) and their introduction of solid foods (early complementary feeding group: <17th week of life corrected for prematurity, late complementary feeding group: ≥17th week of life corrected for prematurity).
Nutritional intake will be estimated based on 24h Recalls at term and after 6 weeks of age corrected for prematurity. Furthermore, 3-days dietary records, an average dietary record and the introduction of the main food categories will be queried at 4 different time points (3 months, 6 months, 9 months and 12 months - all corrected for prematurity) by food questionnaire.
Within these visits anthropometric parameters (height, head circumference and weight), data on body composition (Pea Pod®, BodPod ) \& bio-impedance measurements will be collected. Atopy will be determined by the clinical scoring system SCORAD. For follow up anthropometry and the neurodevelopmental outcome will be assessed by the Bayley Scale at 12 \& 24 months corrected for prematurity and at 40 months of age. Furthermore, K-ABC II (Kaufmann assessment battery for children) will be performed at 66 months of age.
Goals: With this observational study the investigators aim to identify current feeding practices in premature infants and their impact on growth, body composition, atopy and neurodevelopmental outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Early complementary breast feeding | – | –The EARLY complementary feeding group is defined as the introduction of complementary food <17th week of life corrected for term. In addition, infants are stratified to the milk regime, like human milk feeding, at the study enrollment. |
| Early complementary combined feeding | – | –The EARLY complementary feeding group is defined as the introduction of complementary food <17th week of life corrected for term. In addition, infants are stratified to the milk regime, like combined milk feeding, at the study enrollment. |
| Early complementary formula feeding | – | –The EARLY complementary feeding group is defined as the introduction of complementary food <17th week of life corrected for term. In addition, infants are stratified to the milk regime, like formula feeding, at the study enrollment. |
| Late complementary breast feeding | – | –The LATE complementary feeding group is defined as the introduction of complementary food ≥17th week of life corrected for term. In addition, infants are stratified to the milk regime, like human milk feeding, at the study enrollment. |
| Late complementary combined feeding | – | –The LATE complementary feeding group is defined as the introduction of complementary food ≥17th week of life corrected for term. In addition, infants are stratified to the milk regime, like combined milk feeding, at the study enrollment. |
| Late complementary formula feeding | – | –The LATE complementary feeding group is defined as the introduction of complementary food ≥17th week of life corrected for term. In addition, infants are stratified to the milk regime, like formula feeding, at the study enrollment. |
Who may qualify
- Ages
- 1 week to 3 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Preterm infants born with a birth weight <1500g and a gestational age <32 weeks
Key inclusion criteria (2 listed)
- Preterm infants born with a birth weight <1500g and a gestational age <32 weeks
- Informed consent
Key exclusion criteria (4 listed)
- Gastrointestinal diseases: e.g. Hirschsprung disease
- 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.
Primary outcome
Is there a height difference of 5% at one year of age corrected for prematurity between different complementary feeding groups?
Time frame: The patients will be recruited in the period of 04/2016 till 06/2021. The primary observation period is one year.The follow up period lasts until 06/2025
Is there a height difference of 5% at one year of age corrected for prematurity
6 secondary outcomes
Atopy
Time frame: 04/2016 till 06/2025
Body composition
Time frame: 04/2016 till 06/2025
Neurodevelopmental outcome with 1 and 2 years
Time frame: 04/2017 till 06/2025
Neurodevelopmental outcome with 4,5 and 5,5 years
Time frame: 04/2017 till 06/2025
weight
Time frame: 04/2016-06/2025
head circumference
Time frame: 04/2016-06/2025
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- 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.
- Individual participant dataSharing planned: Undecided
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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, 1090 Vienna, Austria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Growth Failure and Atopy, 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 4 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: under way, not looking for participants, as of the sponsor's last update on 7 Apr 2022. 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?
This study is still under way. Results are not available in the source record yet.
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?
Is there a height difference of 5% at one year of age corrected for prematurity between different complementary feeding groups? (time frame: The patients will be recruited in the period of 04/2016 till 06/2021. The primary observation period is one year.The follow up period lasts until 06/2025). 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 NCT02936219, which also lists 1 linked publication.
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 7 Apr 2022; AzTrials last refreshed its copy on 6 Nov 2026.