The PREWEAN Study. Weaning of Preterm Infants During the First Year of Life.
- Conditions
- Growth FailureAdiposityNeurological ImpairmentAtopyCognitive Impairment
- Registration Number
- NCT02936219
- Lead Sponsor
- Medical University of Vienna
- Brief 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 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 218
- Preterm infants born with a birth weight <1500g and a gestational age <32 weeks
- Informed consent
- Gastrointestinal diseases: e.g. Hirschsprung disease
- Congenital heart diseases
- Major congenital birth defects
- Chromosomal aberrations
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Is there a height difference of 5% at one year of age corrected for prematurity between different complementary feeding groups? 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
- Secondary Outcome Measures
Name Time Method Neurodevelopmental outcome with 1 and 2 years 04/2017 till 06/2025 Neurodevelopmental outcome measured by the Bailey III with 1 and 2 years of age corrected for prematurity
Neurodevelopmental outcome with 4,5 and 5,5 years 04/2017 till 06/2025 Neurodevelopmental outcome measured with the KABC- II by 54 and 66 moths of age
Body composition 04/2016 till 06/2025 Fat free mass measure by the body composition devices Peapod and Bodpod
weight 04/2016-06/2025 weight in g or kg
Atopy 04/2016 till 06/2025 Atopy measured by SCORAD
head circumference 04/2016-06/2025 in cm
Trial Locations
- Locations (1)
Medical University of Vienna
🇦🇹Vienna, Austria