PregnancyNCT00783770
Maternal and Infant Cord Blood Monosaccharide Content
An observational study of Pregnancy, run by Arkansas Children's Hospital Research Institute.
Trial summary
Mother's breast milk provides many benefits to babies with regard to development and improved health. We believe the simple sugars which make up these complex sugars in breast milk and are also found in the brain may be critical to normal brain development in term and preterm infants. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Pregnancy
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Jul 2005to Mar 2007
- 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 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Study population: Twenty-four generally healthy mother-infant pairs.
Who may be able to join
- Healthy mothers with ages ranging from 18 to 35 yrs
- Delivered infants appropriate weight for gestational age (between 10% and 90%)
Who cannot join
- Maternal history of smoking, alcohol or drug use
About this study
Official title: Comparison of Monosaccharide Content of Maternal and Umbilical Venous Cord Blood in Term and Preterm Pregnancies
Mother's breast milk provides many benefits to babies with regard to development and improved health. We believe the simple sugars which make up these complex sugars in breast milk and are also found in the brain may be critical to normal brain development in term and preterm infants.
Babies are exposed to these sugars by placental transport during pregnancy and through mother's breast milk after they are born. For the preterm infant, we do not know if breast milk gives enough of these sugars compared to what the baby gets during pregnancy.
A maternal blood sample and blood samples from the baby's umbilical cord will provide us with background information for developing a supplement of special sugars that can be added to infant formulas to provide the amount that the baby usually gets during pregnancy and from breast milk.
- Conditions
- Pregnancy
- Keywords
- Breastfeeding, Infant, Preterm, Nutrition
- Medical subject headings
- Breast Feeding, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 30-33 weeks | mother infant pairs with gestation of 30-33 weeks | |
| 34-37 weeks | mother infant pairs with gestation of 34-37 weeks | |
| 38-42 weeks | mother infant pairs with gestation of 38-42 weeks |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2008 (estimated)
- Study startJul 2005
- Primary completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies 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
- Cross-sectional
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Agriculture (USDA), University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00783770
- Sponsor's protocol ID
- 31247
- Status last verified
- May 2011
- First submitted
- 31 Oct 2008
- Last updated
- 18 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Monosaccharide Content of Maternal and Umbilical Venous Cord Blood in Term and Preterm Pregnancies
- ClinicalTrials.gov ID
- NCT00783770
- Acronym / sponsor ID
- 31247
- Conditions
- Pregnancy
- Keywords
- Breastfeeding, Infant, Preterm, Nutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Collaborators
- United States Department of Agriculture (USDA), University of Arkansas
- Study start
- Jul 2005
- Primary completion
- Mar 2007 (actual)
- First posted
- 3 Nov 2008 (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.
Mother's breast milk provides many benefits to babies with regard to development and improved health. We believe the simple sugars which make up these complex sugars in breast milk and are also found in the brain may be critical to normal brain development in term and preterm infants.
Babies are exposed to these sugars by placental transport during pregnancy and through mother's breast milk after they are born. For the preterm infant, we do not know if breast milk gives enough of these sugars compared to what the baby gets during pregnancy.
A maternal blood sample and blood samples from the baby's umbilical cord will provide us with background information for developing a supplement of special sugars that can be added to infant formulas to provide the amount that the baby usually gets during pregnancy and from breast milk.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 30-33 weeks | – | –mother infant pairs with gestation of 30-33 weeks |
| 34-37 weeks | – | –mother infant pairs with gestation of 34-37 weeks |
| 38-42 weeks | – | –mother infant pairs with gestation of 38-42 weeks |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Twenty-four generally healthy mother-infant pairs.
Key inclusion criteria (2 listed)
- Healthy mothers with ages ranging from 18 to 35 yrs
- Delivered infants appropriate weight for gestational age (between 10% and 90%)
Key exclusion criteria (1 listed)
- Maternal history of smoking, alcohol or drug use
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
Not reported in the source record.
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 18 May 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by Arkansas Children's Hospital Research Institute.
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 2 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 18 May 2011. 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.
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 18 May 2011; AzTrials last refreshed its copy on 6 Nov 2026.