Describe the Infant Feeding AttitudesNCT01233427
Infant Feeding Study.09-68
An observational study of Describe the Infant Feeding Attitudes and Intentions of a Sample of Expectant First-time Mothers, run by Children's Hospital Medical Center, Cincinnati.
Trial summary
Characterize a population-based sample of first-time expectant mothers with regards to maternal metabolic health and their infant feeding experience. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Describe the Infant Feeding Attitudes, Intentions of a Sample of Expectant First-time Mothers, Estimate the Prevalence of Early Lactation Difficulties
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Jun 2009to 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: breastfeeding moms
Who may be able to join
- First-time expectant mother, speaks English, receiving OB care at designated practice group
Who cannot join
- 1) Under 18 years old; 2)no access to local telephone 3) multiple gestation 4) history of major breast surgery
About this study
Official title: The Infant Feeding Experience of New Mothers - a Descriptive Pilot Study.
Characterize a population-based sample of first-time expectant mothers with regards to maternal metabolic health and their infant feeding experience.
Read the detailed description
The long range purpose of this pilot study is to inform the development of an NIH-funded randomized intervention trial designed to improve early breastfeeding outcomes for mothers planning to breastfeed. The purpose of the pilot study is to 1) described the prenatal infant feeding attitudes and intentions of population-based sample of expectant mothers from the same recruitment base as the future intervention trial, 2) characterize the metabolic health profiles of the sample and 3) estimate the prevalence of early lactation difficulties among the subset of this sample that initiates breastfeeding.
What is being measured
The primary outcome is the main question the study is designed to answer.
Early lactation difficulties
a)Estimate the prevalence of early lactation difficulties among the subset of this sample that initiates breastfeeding, b) examine the relationship between metabolic health and lactation difficulties
Measured: 1 year
Secondary outcomes (1)
Infant feeding attitudes
describe the prenatal infant feeding attitudes and intentions of a sample of expectant mothers from the same recruitment base as the future intervention trial
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2010 (estimated)
- Study startJun 2009
- Primary completionNov 2010
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Describe the Infant Feeding AttitudesStudies 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurie A Nommsen-Rivers, PhD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01233427
- Sponsor's protocol ID
- 09-68
- Status last verified
- Aug 2014
- First submitted
- 2 Nov 2010
- Last updated
- 25 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Nommsen-Rivers LA, Dolan LM, Huang B. Timing of stage II lactogenesis is predicted by antenatal metabolic health in a cohort of primiparas. Breastfeed Med. 2012 Feb;7(1):43-9. doi: 10.1089/bfm.2011.0007. Epub 2011 Apr 27.
PubMed 21524193
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Infant Feeding Experience of New Mothers - a Descriptive Pilot Study.
- ClinicalTrials.gov ID
- NCT01233427
- Acronym / sponsor ID
- 09-68
- Conditions
- Describe the Infant Feeding Attitudes, Intentions of a Sample of Expectant First-time Mothers, Estimate the Prevalence of Early Lactation Difficulties
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 3 Nov 2010 (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.
Characterize a population-based sample of first-time expectant mothers with regards to maternal metabolic health and their infant feeding experience.
Detailed description
The long range purpose of this pilot study is to inform the development of an NIH-funded randomized intervention trial designed to improve early breastfeeding outcomes for mothers planning to breastfeed. The purpose of the pilot study is to 1) described the prenatal infant feeding attitudes and intentions of population-based sample of expectant mothers from the same recruitment base as the future intervention trial, 2) characterize the metabolic health profiles of the sample and 3) estimate the prevalence of early lactation difficulties among the subset of this sample that initiates breastfeeding.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- breastfeeding moms
Key inclusion criteria (1 listed)
- First-time expectant mother, speaks English, receiving OB care at designated practice group
Key exclusion criteria (1 listed)
- 1) Under 18 years old; 2)no access to local telephone 3) multiple gestation 4) history of major breast surgery
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
Early lactation difficulties
Time frame: 1 year
a)Estimate the prevalence of early lactation difficulties among the subset of this sample that initiates breastfeeding, b) examine the relationship between metabolic health and lactation difficulties
1 secondary outcome
Infant feeding attitudes
Time frame: 1 year
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 25 Aug 2014.
- Results publication: PubMed 21524193Nommsen-Rivers LA, Dolan LM, Huang B. Timing of stage II lactogenesis is predicted by antenatal metabolic health in a cohort of primiparas. Breastfeed Med. 2012 Feb;7(1):43-9. doi: 10.1089/bfm.2011.0007. Epub 2011 Apr 27.
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.
Laurie A Nommsen-Rivers, PhD principal investigator
Children's Hospital Medical Center, Cincinnati
Questions about this trial
What is this clinical trial studying?
An observational study of Describe the Infant Feeding Attitudes and Intentions of a Sample of Expectant First-time Mothers, run by Children's Hospital Medical Center, Cincinnati.
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 25 Aug 2014. 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?
Early lactation difficulties (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01233427, which also lists 1 linked publication.
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 25 Aug 2014.