BreastfeedingNCT00527956
Facilitation and Barriers to Breastfeeding in the NICU
An observational study of Breastfeeding and Prematurity, run by McGill University Health Centre/Research Institute of the McGill University Health Centre.
Trial summary
To date, there is a paucity of research focusing on maternal breastfeeding goals, how these goals may change after an unexpected event such as a preterm birth, and how mothers of ill and preterm infants define breastfeeding success. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding, Prematurity
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- Sep 2007to Apr 2008
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- have one (or more) infant(s) currently admitted in the NICU at the RVH;
- intended to provide breast milk to their infant(s);
- are able to speak English; and
- are willing to be audiotaped during the interview.
Who cannot join
- Include mothers who:
- never intended to breastfeed;
- have high risk social situations (for example, known maternal mental illness; involvement of youth protection; known alcohol and drug abuse; adoption; identified congenital anomalies);
- gave birth at term; and
- have infants with significant birth defects or serious medical conditions in addition to prematurity.
About this study
To date, there is a paucity of research focusing on maternal breastfeeding goals, how these goals may change after an unexpected event such as a preterm birth, and how mothers of ill and preterm infants define breastfeeding success. No studies were identified that focused exclusively on the breastfeeding goals of mothers of hospitalized preterm infants
The purpose of this study is to answer the following research questions: 1) What are the breastfeeding goals of mothers with preterm infants in the NICU? and 2) What are mothers' perceptions of facilitators and barriers to meeting their breastfeeding goals in the NICU?
Read the detailed description
As the objective of this study is to describe the breastfeeding goals of mothers and their perceptions of breastfeeding support in the NICU, this study will follow a descriptive, qualitative design. Mothers of preterm newborns in the Royal Victoria Hospital will participate in a semi-structured interview about their breastfeeding goals and what they perceived to be facilitators and barriers to achieving their intended goals. During the interviews, the mothers will be asked a set of socio-demographic questions, open-ended questions about their breastfeeding goals, and open-ended questions about their perceptions of barriers and facilitators to meeting these goals in the NICU Participants may also receive one follow-up phone call to clarify their responses to the questions or to validate the information obtained from the interview.
- Conditions
- Breastfeeding, Prematurity
- Keywords
- Breastfeeding premature infants
- Medical subject headings
- Breast Feeding, Premature Birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2007 (estimated)
- Study startSep 2007
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- 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
- Time perspective
- Prospective
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Investigators
- Luisa Ciofani, RN, M.Sc.(A), Principal investigator, McGill Univsersity Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00527956
- Sponsor's protocol ID
- PSY 07-009
- Status last verified
- Jun 2008
- First submitted
- 10 Sep 2007
- Last updated
- 9 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facilitation and Barriers to Breastfeeding in the NICU
- ClinicalTrials.gov ID
- NCT00527956
- Acronym / sponsor ID
- PSY 07-009
- Conditions
- Breastfeeding, Prematurity
- Keywords
- Breastfeeding premature infants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- Sep 2007
- Study completion
- Apr 2008 (actual)
- First posted
- 11 Sep 2007 (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.
To date, there is a paucity of research focusing on maternal breastfeeding goals, how these goals may change after an unexpected event such as a preterm birth, and how mothers of ill and preterm infants define breastfeeding success. No studies were identified that focused exclusively on the breastfeeding goals of mothers of hospitalized preterm infants
The purpose of this study is to answer the following research questions: 1) What are the breastfeeding goals of mothers with preterm infants in the NICU? and 2) What are mothers' perceptions of facilitators and barriers to meeting their breastfeeding goals in the NICU?
Detailed description
As the objective of this study is to describe the breastfeeding goals of mothers and their perceptions of breastfeeding support in the NICU, this study will follow a descriptive, qualitative design. Mothers of preterm newborns in the Royal Victoria Hospital will participate in a semi-structured interview about their breastfeeding goals and what they perceived to be facilitators and barriers to achieving their intended goals. During the interviews, the mothers will be asked a set of socio-demographic questions, open-ended questions about their breastfeeding goals, and open-ended questions about their perceptions of barriers and facilitators to meeting these goals in the NICU Participants may also receive one follow-up phone call to clarify their responses to the questions or to validate the information obtained from the interview.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- have one (or more) infant(s) currently admitted in the NICU at the RVH;
- intended to provide breast milk to their infant(s);
- are able to speak English; and
- are willing to be audiotaped during the interview.
Key exclusion criteria (5 listed)
- never intended to breastfeed;
- have high risk social situations (for example, known maternal mental illness; involvement of youth protection; known alcohol and drug abuse; adoption; identified congenital anomalies);
- gave birth at term; and
- have infants with significant birth defects or serious medical conditions in addition to prematurity.
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 9 Jun 2008.
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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.
Luisa Ciofani, RN, M.Sc.(A) principal investigator
McGill Univsersity Health Centre
Questions about this trial
What is this clinical trial studying?
An observational study of Breastfeeding and Prematurity, run by McGill University Health Centre/Research Institute of the McGill University Health Centre.
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 4 inclusion and 5 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 9 Jun 2008. 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 9 Jun 2008.