Premature Birth of NewbornBabyGrowNCT01881256
The BabyGrow Longitudinal Study of Nutrition and Growth in Preterm Infants
An observational study of Premature Birth of Newborn and Malnutrition; Intrauterine or Fetal, Small-for-dates, run by University College Cork.
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… Read more about this study
- Who is it for?
- Ages Up to 34 weeks
- Conditions the study is for
- Premature Birth of Newborn, Malnutrition; Intrauterine or Fetal, Small-for-dates
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Mar 2010to Oct 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 34 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Preterm infants admitted to Cork University Maternity Hospital Neonatal Unit
Who may be able to join
- Babies with a birth weight ≤1.5kg and gestational age ≤34 weeks were considered eligible.
Who cannot join
- presence of congenital abnormalities or conditions that interfere with growth or body composition (congenital diseases, chromosomal abnormalities, chronic lung disease, cardiac or gastrointestinal diseases).
About this study
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.
Read the 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.
- Keywords
- Preterm birth, Parenteral and enteral nutrition, Body composition in preterm infants
- Medical subject headings
- Premature Birth, Malnutrition
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 19 months
Secondary outcomes (2)
Longitudinal data on body composition in Irish preterm neonates
Evaluation of appropriateness of current feeding regimens for achievement of optimal growth \& body composition outcomes
Measured: 19 months
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.
Measured: 19 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2013 (estimated)
- Study startMar 2010
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Birth of NewbornStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Cork
- Sponsor type
- University, hospital or other
- Collaborators
- Cork University Hospital
- Responsible party
- Principal investigator, Mairead Kiely, University College Cork
- Investigators
- Mairead E Kiely, PhD, Principal investigator, University College Cork
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01881256
- Sponsor's protocol ID
- BabyGrow1 Study
- Acronym
- BabyGrow
- Status last verified
- Jun 2013
- First submitted
- 17 Jun 2013
- Last updated
- 19 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The BabyGrow Longitudinal Study of Nutrition and Growth in Preterm Infants
- ClinicalTrials.gov ID
- NCT01881256
- Acronym / sponsor ID
- BabyGrow / BabyGrow1 Study
- Keywords
- Preterm birth, Parenteral and enteral nutrition, Body composition in preterm infants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University College CorkUniversity, hospital or other
- Collaborators
- Cork University Hospital
- Study start
- Mar 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 19 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 34 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Preterm infants admitted to Cork University Maternity Hospital Neonatal Unit
Key inclusion criteria (1 listed)
- Babies with a birth weight ≤1.5kg and gestational age ≤34 weeks were considered eligible.
Key exclusion criteria (1 listed)
- presence of congenital abnormalities or conditions that interfere with growth or body composition (congenital diseases, chromosomal abnormalities, chronic lung disease, cardiac or gastrointestinal diseases).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Longitudinal data on body composition in Irish preterm neonates
Time frame: 19 months
Longitudinal data on vitamin D intake and circulating 25(OH)D
Time frame: 19 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mairead E Kiely, PhD principal investigator
University College Cork
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Birth of Newborn and Malnutrition; Intrauterine or Fetal, Small-for-dates, run by University College Cork.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Actual nutrient intake vs recommended nutrient requirements in preterm infants (time frame: 19 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2013.