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Completed

NCT Number: NCT01881256

The BabyGrow Longitudinal Study of Nutrition and Growth in Preterm Infants

This is a longitudinal, observational study on nutrition, growth and body composition in preterm infants. Aims to determine the adequacy of actual nutrient intake during the preterm period by investigating associations between macronutrient supply, growth, and body composition at 34-weeks gestation, term equivalent and 2-month corrected gestational age.

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Key information

About this study

Infants between 23 and 24 weeks gestation and with a birth weight of 500 to 1500 g are recruited to a longitudinal, observational study of nutrition, growth and body composition in Cork University Maternity Hospital, Ireland.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Babies with a birth weight ≤1.5kg and gestational age ≤34 weeks were considered eligible.

Exclusion criteria

  • presence of congenital abnormalities or conditions that interfere with growth or body composition (congenital diseases, chromosomal abnormalities, chronic lung disease, cardiac or gastrointestinal diseases).

Treatment and study plan

Primary outcomes

  1. Actual nutrient intake vs recommended nutrient requirements in preterm infants

    Time frame: 19 months

    Comparison of intake with requirements during the preterm infant's hospital stay and up to 2 months corrected gestational age.

Secondary outcomes

  1. Longitudinal data on body composition in Irish preterm neonates

    Time frame: 19 months

    Evaluation of appropriateness of current feeding regimens for achievement of optimal growth & body composition outcomes

  2. Longitudinal data on vitamin D intake and circulating 25(OH)D

    Time frame: 19 months

    To examine the relationship between vitamin D intake and serum 25-hydroxyvitamin D concentrations and biomarkers of calcium handling by analysis of sequential serum samples.

Sponsors and collaborators

Lead sponsor

University College Cork

Other

Collaborators

  • Cork University Hospital

Registry information

Acronym: BabyGrow

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 19, 2013
Registry last updated
Jun 19, 2013

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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