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

Cognitive Impairment Clinical Trial

— PREWEAN  

Official title:

Weaning of Preterm Infants During the First Year of Life: Impact on Anthropometry, Body Composition, Atopy and Neurodevelopmental Outcome

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02936219
• Other study ID #: PREWEAN
• Status: Active, not recruiting
• Start date: April 2016
• Est. completion date: December 2026

Study information

• Verified date: April 2022
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 218
• Est. completion date: December 2026
• Est. primary completion date: December 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 3 Months

Eligibility

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

Related Conditions & MeSH terms

• Adiposity
• Atopy
• Cognitive Dysfunction
• Cognitive Impairment
• Failure to Thrive
• Growth Failure
• Neurological Impairment

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (3)

Lead Sponsor	Collaborator
Medical University of Vienna	Kaiser Franz Josef Hospital, Wilhelminenspital Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Atopy	Atopy measured by SCORAD	04/2016 till 06/2025
Secondary	Body composition	Fat free mass measure by the body composition devices Peapod and Bodpod	04/2016 till 06/2025
Secondary	Neurodevelopmental outcome with 1 and 2 years	Neurodevelopmental outcome measured by the Bailey III with 1 and 2 years of age corrected for prematurity	04/2017 till 06/2025
Secondary	Neurodevelopmental outcome with 4,5 and 5,5 years	Neurodevelopmental outcome measured with the KABC- II by 54 and 66 moths of age	04/2017 till 06/2025
Secondary	weight	weight in g or kg	04/2016-06/2025
Secondary	head circumference	in cm	04/2016-06/2025