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

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ClinicalTrials.gov Identifier: NCT01881256
Recruitment Status : Completed
First Posted : June 19, 2013
Last Update Posted : June 19, 2013
Sponsor:
Collaborator:
Cork University Hospital
Information provided by (Responsible Party):
Mairead Kiely, University College Cork

Brief 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.

Condition or disease
Premature Birth of Newborn Malnutrition; Intrauterine or Fetal, Small-for-dates

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.

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Study Type : Observational
Actual Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The BabyGrow Longitudinal Study of Nutrition and Growth in Preterm Infants
Study Start Date : March 2010
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   up to 34 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Preterm infants admitted to Cork University Maternity Hospital Neonatal Unit
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01881256


Sponsors and Collaborators
University College Cork
Cork University Hospital
Investigators
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Principal Investigator: Mairead E Kiely, PhD University College Cork

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Responsible Party: Mairead Kiely, Dr, University College Cork
ClinicalTrials.gov Identifier: NCT01881256     History of Changes
Other Study ID Numbers: BabyGrow1 Study
First Posted: June 19, 2013    Key Record Dates
Last Update Posted: June 19, 2013
Last Verified: June 2013
Keywords provided by Mairead Kiely, University College Cork:
Preterm birth
Parenteral and enteral nutrition
Body composition in preterm infants
Additional relevant MeSH terms:
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Premature Birth
Malnutrition
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Nutrition Disorders