Medical University of Vienna
Vienna, 1090, Austria
NCT Number: NCT02936219
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.
This study is active but is not currently recruiting participants.
1 week–3 month
All sexes
Observational
Vienna, 1090, Austria
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 04/2016 till 06/2025
Atopy measured by SCORAD
Time frame: 04/2016 till 06/2025
Fat free mass measure by the body composition devices Peapod and Bodpod
Time frame: 04/2017 till 06/2025
Neurodevelopmental outcome measured by the Bailey III with 1 and 2 years of age corrected for prematurity
Time frame: 04/2017 till 06/2025
Neurodevelopmental outcome measured with the KABC- II by 54 and 66 moths of age
Time frame: 04/2016-06/2025
weight in g or kg
Time frame: 04/2016-06/2025
in cm
Medical University of Vienna
Other
Weaning of Preterm Infants During the First Year of Life: Impact on Anthropometry, Body Composition, Atopy and Neurodevelopmental Outcome
Acronym: PREWEAN
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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