- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02936219
The PREWEAN Study. Weaning of Preterm Infants During the First Year of Life. (PREWEAN)
Weaning of Preterm Infants During the First Year of Life: Impact on Anthropometry, Body Composition, Atopy and Neurodevelopmental Outcome
Study Overview
Status
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Vienna, Austria, 1090
- Medical University of Vienna
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Preterm infants born with a birth weight <1500g and a gestational age <32 weeks
- Informed consent
Exclusion Criteria:
- Gastrointestinal diseases: e.g. Hirschsprung disease
- Congenital heart diseases
- Major congenital birth defects
- Chromosomal aberrations
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Is there a height difference of 5% at one year of age corrected for prematurity
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Atopy
Time Frame: 04/2016 till 06/2025
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Atopy measured by SCORAD
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04/2016 till 06/2025
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Body composition
Time Frame: 04/2016 till 06/2025
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Fat free mass measure by the body composition devices Peapod and Bodpod
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04/2016 till 06/2025
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Neurodevelopmental outcome with 1 and 2 years
Time Frame: 04/2017 till 06/2025
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Neurodevelopmental outcome measured by the Bailey III with 1 and 2 years of age corrected for prematurity
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04/2017 till 06/2025
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Neurodevelopmental outcome with 4,5 and 5,5 years
Time Frame: 04/2017 till 06/2025
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Neurodevelopmental outcome measured with the KABC- II by 54 and 66 moths of age
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04/2017 till 06/2025
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weight
Time Frame: 04/2016-06/2025
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weight in g or kg
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04/2016-06/2025
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head circumference
Time Frame: 04/2016-06/2025
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in cm
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04/2016-06/2025
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nadja Haiden, Medical University of Vienna, 1090 Vienna, Austria
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PREWEAN
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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