An observational study in Growth Failure, Atopy and Adiposity, sponsored by Medical University of Vienna. Active, not recruiting at 1 site in Austria. Open to participants aged 1 Week to 3 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-07.
Sponsored by Medical University of Vienna · Observational
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.
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.
84 studies on the registry are indexed under Failure to Thrive; 12 are open to participants now.
This study's enrollment of 218 is above the median of 165 across 24 observational studies indexed under Failure to Thrive.
Browse Failure to Thrive studies →Medical University of Vienna is the lead sponsor of 1,109 studies on the registry; 184 are open to participants now.
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Preterm infants born with a birth weight \<1500g and a gestational age \<32 weeks
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
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.
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.
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.
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
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
Atopy
Atopy measured by SCORAD
Time frame: 04/2016 till 06/2025
Body composition
Fat free mass measure by the body composition devices Peapod and Bodpod
Time frame: 04/2016 till 06/2025
Neurodevelopmental outcome with 1 and 2 years
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 with 4,5 and 5,5 years
Neurodevelopmental outcome measured with the KABC- II by 54 and 66 moths of age
Time frame: 04/2017 till 06/2025
weight
weight in g or kg
Time frame: 04/2016-06/2025
head circumference
in cm
Time frame: 04/2016-06/2025
Plan to share: Undecided
No publications or documents are linked to this record.
The record gives a start of Apr 2016, a primary completion of Dec 2021 and a completion of Dec 2026. It does not say whether these dates are actual or estimated.
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This study is active, not recruiting, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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