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NCT01881256 Clinical Trial

The BabyGrow Longitudinal Study of Nutrition and Growth in Preterm Infants

Premature Birth of Newborn Clinical Trial

— BabyGrow  

Official title:
The BabyGrow Longitudinal Study of Nutrition and Growth in Preterm Infants

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01881256
Other study ID # BabyGrow1 Study
Secondary ID
Status Completed
Phase N/A
First received June 17, 2013
Last updated June 18, 2013
Start date March 2010
Est. completion date October 2011

Study information
Verified date June 2013
Source University College Cork
Contact n/a
Is FDA regulated No
Health authority Ireland: Medical Ethics Research Committee
Study type Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 70
Est. completion date October 2011
Est. primary completion date October 2011
Accepts healthy volunteers No
Gender Both
Age group N/A to 34 Weeks
Eligibility 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).

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
University College Cork Cork University Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary Actual nutrient intake vs recommended nutrient requirements in preterm infants Comparison of intake with requirements during the preterm infant's hospital stay and up to 2 months corrected gestational age. 19 months No
Secondary Longitudinal data on body composition in Irish preterm neonates Evaluation of appropriateness of current feeding regimens for achievement of optimal growth & body composition outcomes 19 months No
Secondary Longitudinal data on vitamin D intake and circulating 25(OH)D 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. 19 months No
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