HealthyNCT00195962
Risk Factors of Breastfeeding Study
An observational study of Healthy, run by Children's Mercy Hospital Kansas City at 3 sites in United States.
Trial summary
The goal of this study is to identify infants who are at risk for developing problems related to being breast-fed. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 1,500 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2004to Jun 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: * Mothers of healthy infants that are breastfeeding * At least 24 hours post delivery * Mother and baby will be dismissed from the hospital together.
Who may be able to join
- Mothers of healthy infants that are breastfeeding
- At least 24 hours post delivery
- Mother and baby will be dismissed from the hospital together.
Who cannot join
- Mothers of newborns that are not breastfeeding
- Mothers of newborns that are ill and/or will not be dismissed from the hospital at the same time as the mother
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, 64108
Truman Medical Center - Hospital Hill
Kansas City, Missouri, 64108
Truman Medical Center - Lakewood
Lee's Summit, Missouri, 64139
About this study
Official title: Identification of Risk Factors Among Breast-Fed Infants
The goal of this study is to identify infants who are at risk for developing problems related to being breast-fed.
Read the detailed description
The goal of this study is to identify infants who are at risk for developing problems related to being breast-fed. A previous study identified items that place an infant at a high risk for developing complications related to being breast-fed. The present study will use the same survey and collect data from more participants. These additional participants are necessary to provide statistical analysis for the survey. The survey being developed will assist health care professionals to identify those infants at risk for developing health problems related to being breast-fed and provide care that will minimize the chances of developing complications.
- Conditions
- Healthy
- Keywords
- Breastfeeding, Post-partum mothers of healthy breast-fed newborns
- Medical subject headings
- Breast Feeding
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJun 2004
- Primary completionJun 2007
- Study completionJun 2007
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 HealthyStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Investigators
- Anne Mercer, RN, Principal investigator, Children's Mercy Hospital Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00195962
- Sponsor's protocol ID
- 040107
- Status last verified
- May 2008
- First submitted
- 13 Sep 2005
- Last updated
- 18 Dec 2008
- Results posted
- No
Publications
Hall RT, Mercer AM, Teasley SL, McPherson DM, Simon SD, Santos SR, Meyers BM, Hipsh NE. A breast-feeding assessment score to evaluate the risk for cessation of breast-feeding by 7 to 10 days of age. J Pediatr. 2002 Nov;141(5):659-64. doi: 10.1067/mpd.2002.129081.
PubMed 12410194
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Risk Factors Among Breast-Fed Infants
- ClinicalTrials.gov ID
- NCT00195962
- Acronym / sponsor ID
- 040107
- Conditions
- Healthy
- Keywords
- Breastfeeding, Post-partum mothers of healthy breast-fed newborns
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Study start
- Jun 2004
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 20 Sep 2005 (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.
The goal of this study is to identify infants who are at risk for developing problems related to being breast-fed.
Detailed description
The goal of this study is to identify infants who are at risk for developing problems related to being breast-fed. A previous study identified items that place an infant at a high risk for developing complications related to being breast-fed. The present study will use the same survey and collect data from more participants. These additional participants are necessary to provide statistical analysis for the survey. The survey being developed will assist health care professionals to identify those infants at risk for developing health problems related to being breast-fed and provide care that will minimize the chances of developing complications.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- * Mothers of healthy infants that are breastfeeding * At least 24 hours post delivery * Mother and baby will be dismissed from the hospital together.
Key inclusion criteria (3 listed)
- Mothers of healthy infants that are breastfeeding
- At least 24 hours post delivery
- Mother and baby will be dismissed from the hospital together.
Key exclusion criteria (2 listed)
- Mothers of newborns that are not breastfeeding
- Mothers of newborns that are ill and/or will not be dismissed from the hospital at the same time as the mother
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 Dec 2008.
- Background: PubMed 12410194Hall RT, Mercer AM, Teasley SL, McPherson DM, Simon SD, Santos SR, Meyers BM, Hipsh NE. A breast-feeding assessment score to evaluate the risk for cessation of breast-feeding by 7 to 10 days of age. J Pediatr. 2002 Nov;141(5):659-64. doi: 10.1067/mpd.2002.129081.
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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.
Anne Mercer, RN principal investigator
Children's Mercy Hospital Kansas City
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Children's Mercy Hospital Kansas City at 3 sites in United States.
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 3 inclusion and 2 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 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
On the ClinicalTrials.gov record for NCT00195962, 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 18 Dec 2008.