The BabyGrow Longitudinal Study of Nutrition and Growth in Preterm Infants (BabyGrow)

June 18, 2013 updated by: Mairead Kiely, University College Cork
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.

Study Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

70

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 7 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Preterm infants admitted to Cork University Maternity Hospital Neonatal Unit

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
19 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
19 months
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.
19 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College Cork

Collaborators

Cork University Hospital

Investigators

  • Principal Investigator: Mairead E Kiely, PhD, University College Cork

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

June 17, 2013

First Submitted That Met QC Criteria

June 18, 2013

First Posted (Estimate)

June 19, 2013

Study Record Updates

Last Update Posted (Estimate)

June 19, 2013

Last Update Submitted That Met QC Criteria

June 18, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BabyGrow1 Study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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