PrematurityNCT01050192
Nutritional Content of Breast Milk From Mothers of Premies
An observational study of Prematurity and Nutrition, run by Pediatrix at 1 site in United States.
Trial summary
The purpose of this study is to determine the correlation, if any, between the nutritional content of breast milk pumped by the mothers of very low birth weight (VLBW) infants in the neonatal intensive care unit (NICU) and the nutritional value they are actually receiving in a 24 hour period, since as a practical… Read more about this study
- Who is it for?
- Ages 23 to 30 weeksHealthy volunteers can take part
- Conditions the study is for
- Prematurity, Nutrition
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Sep 2010
- 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 23 to 30 weeks
- All sexes
- Healthy volunteers accepted
- Child
Study population: Neonatal Intensive Care Unit
Who may be able to join
- Mothers of infants with a gestational age <=30 weeks in the NICU who are supplying their own breast milk for use by their baby
- Reasonable likelihood of survival of infant to 28 days
- Infant on/ready for oral feeding by DOL 7 days
- Willing to provide breast milk for their baby
- Able to produce at least 7mL breast milk per feeding
- Willing to abide by requirements of the study protocol
- Documentation of informed consent
Who cannot join
- Unable to provide at least 7mL breast milk per feeding
- Medically unsuitable to provide breast milk to her baby
- Maternal age <18 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
Greenville Memorial Hospital
Greenville, South Carolina
About this study
Official title: The Nutritional Content of Breast Milk From Mothers of Premature Neonates During the First 28 Days of Life
The purpose of this study is to determine the correlation, if any, between the nutritional content of breast milk pumped by the mothers of very low birth weight (VLBW) infants in the neonatal intensive care unit (NICU) and the nutritional value they are actually receiving in a 24 hour period, since as a practical matter, these may not be the same.
- Conditions
- Prematurity, Nutrition
- Keywords
- Prematurity, Nutrition, Breast Feeding
- Medical subject headings
- Premature Birth, Breast Feeding
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the correlation, if any, between the nutritional content of breast milk pumped by the mothers of VLBW infants in the NICU and the nutritional value they are actually receiving in a 24 hour period.
Measured: 28 days of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2010 (estimated)
- Study startDec 2009
- Primary completionSep 2010
- Study completionSep 2010
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrematurityStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pediatrix
- Sponsor type
- University, hospital or other
- Collaborators
- Prolacta Bioscience
- Responsible party
- Principal investigator, Amy Kelleher, Pediatrix
- Investigators
- Reese Clark, MD, Principal investigator, Greenville Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01050192
- Sponsor's protocol ID
- Pro0001271
- Status last verified
- Mar 2017
- First submitted
- 13 Jan 2010
- Last updated
- 23 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Nutritional Content of Breast Milk From Mothers of Premature Neonates During the First 28 Days of Life
- ClinicalTrials.gov ID
- NCT01050192
- Acronym / sponsor ID
- Pro0001271
- Conditions
- Prematurity, Nutrition
- Keywords
- Prematurity, Nutrition, Breast Feeding
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Lack of enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PediatrixUniversity, hospital or other
- Collaborators
- Prolacta Bioscience
- Study start
- Dec 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 15 Jan 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.
The purpose of this study is to determine the correlation, if any, between the nutritional content of breast milk pumped by the mothers of very low birth weight (VLBW) infants in the neonatal intensive care unit (NICU) and the nutritional value they are actually receiving in a 24 hour period, since as a practical matter, these may not be the same.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 23 to 30 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Neonatal Intensive Care Unit
Key inclusion criteria (7 listed)
- Mothers of infants with a gestational age <=30 weeks in the NICU who are supplying their own breast milk for use by their baby
- Reasonable likelihood of survival of infant to 28 days
- Infant on/ready for oral feeding by DOL 7 days
- Willing to provide breast milk for their baby
- Able to produce at least 7mL breast milk per feeding
Key exclusion criteria (3 listed)
- Unable to provide at least 7mL breast milk per feeding
- Medically unsuitable to provide breast milk to her baby
- Maternal age <18 years of age
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
To determine the correlation, if any, between the nutritional content of breast milk pumped by the mothers of VLBW infants in the NICU and the nutritional value they are actually receiving in a 24 hour period.
Time frame: 28 days of life
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2017.
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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.
Reese Clark, MD principal investigator
Greenville Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prematurity and Nutrition, run by Pediatrix at 1 site 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 7 inclusion and 3 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: withdrawn, as of the sponsor's last update on 23 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was withdrawn before enrolling participants, so there are no results.
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?
To determine the correlation, if any, between the nutritional content of breast milk pumped by the mothers of VLBW infants in the NICU and the nutritional value they are actually receiving in a 24 hour period. (time frame: 28 days of life). 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 23 Mar 2017; AzTrials last refreshed its copy on 8 Nov 2026.