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The PREWEAN Study. Weaning of Preterm Infants During the First Year of Life.

Active, not recruiting
Conditions
Growth Failure
Adiposity
Neurological Impairment
Atopy
Cognitive 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
Inclusion Criteria
  • Preterm infants born with a birth weight <1500g and a gestational age <32 weeks
  • Informed consent
Read More
Exclusion Criteria
  • Gastrointestinal diseases: e.g. Hirschsprung disease
  • Congenital heart diseases
  • Major congenital birth defects
  • Chromosomal aberrations
Read More

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
Neurodevelopmental outcome with 1 and 2 years04/2017 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 years04/2017 till 06/2025

Neurodevelopmental outcome measured with the KABC- II by 54 and 66 moths of age

Body composition04/2016 till 06/2025

Fat free mass measure by the body composition devices Peapod and Bodpod

weight04/2016-06/2025

weight in g or kg

Atopy04/2016 till 06/2025

Atopy measured by SCORAD

head circumference04/2016-06/2025

in cm

Trial Locations

Locations (1)

Medical University of Vienna

🇦🇹

Vienna, Austria

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