BreastfeedingPLEASENCT02349464
Promoting Lactation Education, Access, and Support Efforts for Preterm Infants
A study testing Specialized Preterm Infant/Mother Dyad Lactation Support in people with Breastfeeding, run by Medical University of South Carolina.
Trial summary
The purpose of this study is to determine whether a post-hospital discharge lactation support system increases preterm infant intake of mother's milk. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breastfeeding
- What is being tested?
- Specialized Preterm Infant/Mother Dyad Lactation Support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Apr 2018
- Phase
- Interventional
- 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
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Any infant discharge to home from the Medical University of South Carolina neonatal services
- Born <35 weeks' gestation
- Mother providing her milk and plans to continue providing her milk for at least 6 months
- The infant's post-discharge pediatric clinic identified by mother as one involved in the study
- The eligible twin will be the first twin discharged from the hospital or, if discharge occurs simultaneously, the infant identified in the hospital as "twin A" will be eligible.
Who cannot join
- Infants with major congenital anomalies
- Infants with anomalies affecting oral intake
- Infants receiving tube feeds at hospital discharge
- Infants receiving parenteral nutrition at hospital discharge
- Triplet or greater pregnancies
- Twin of the one enrolled twin will not be eligible.
About this study
The purpose of this study is to determine whether a post-hospital discharge lactation support system increases preterm infant intake of mother's milk.
Read the detailed description
Preterm infants have barriers to successful breastfeeding that include oral feeding immaturity and high nutritional needs. Therefore, successful preterm infant breastfeeding requires increased counseling and equipment support compared to full-term infant breastfeeding. Inpatient preterm infant care has responded to these barriers, with specialized preterm infant lactation support. Unfortunately, for preterm infants, the onset of feeding maturity often coincides with hospital discharge and, therefore, inpatient, specialized lactation support ends just as the infant initiates nutritive feeding at the breast. Therefore, the success of preterm infant breastfeeding relies on the home environment and the community pediatric caregivers. A program has been created to provide this specialized preterm infant/mother outpatient lactation support. The program includes in-home availability of a hospital-grade electric pump and an infant weigh scale and pediatric clinic-based lactation counseling support. Fourteen pediatric practices are included in this study. Seven practices were randomized to intervention and seven were randomized to be controls.
- Conditions
- Breastfeeding
- Being tested
- Specialized Preterm Infant/Mother Dyad Lactation Support
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specialized Preterm Infant/Mother Dyad Lactation SupportOther
Mother will receive home equipment and pediatric clinic lactation support.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | For infants receiving pediatric care at one of the seven intervention practices, mothers will receive the Specialized Preterm Infant/Mother Dyad Lactation Support which includes home equipment and pediatric clinic-lactation support to support lactation for four months post-hospital discharge. Receives: Other: Specialized Preterm Infant/Mother Dyad Lactation Support |
| Control | No intervention | For infants receiving pediatric care at one of the seven control practices, mothers will receive standard support. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preterm infant intake of mother's milk post-hospital discharge measured by survey.
Measured: 4 months
Secondary outcomes (6)
Preterm infant breastfeeding post-hospital discharge measured by survey.
Measured: 4 months
Sustaining preterm infant mother's milk intake post-hospital discharge measured by survey.
Measured: 6 months
Preterm infant growth post-hospital discharge collected from pediatric clinic medical record.
Measured: 6 months
Preterm infant re-hospitalization post-hospital discharge collected from pediatric clinic medical record.
Measured: 6 months
Preterm infant respiratory illness events post-hospital discharge collected from pediatric clinic medical record.
Measured: 6 months
Preterm infant gastrointestinal illness events post-hospital discharge collected from pediatric clinic medical record.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2015 (estimated)
- Study startDec 2014
- Primary completionFeb 2018
- Study completionApr 2018
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 Medical University of South CarolinaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah N Taylor, MD, MSCR, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02349464
- Sponsor's protocol ID
- HR#27878
- Acronym
- PLEASE
- Status last verified
- Jun 2018
- First submitted
- 15 Jan 2015
- Last updated
- 13 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Lactation Education, Access, and Support Efforts for Preterm Infants
- ClinicalTrials.gov ID
- NCT02349464
- Acronym / sponsor ID
- PLEASE / HR#27878
- Conditions
- Breastfeeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Feb 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 29 Jan 2015 (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 whether a post-hospital discharge lactation support system increases preterm infant intake of mother's milk.
Detailed description
Preterm infants have barriers to successful breastfeeding that include oral feeding immaturity and high nutritional needs. Therefore, successful preterm infant breastfeeding requires increased counseling and equipment support compared to full-term infant breastfeeding. Inpatient preterm infant care has responded to these barriers, with specialized preterm infant lactation support. Unfortunately, for preterm infants, the onset of feeding maturity often coincides with hospital discharge and, therefore, inpatient, specialized lactation support ends just as the infant initiates nutritive feeding at the breast. Therefore, the success of preterm infant breastfeeding relies on the home environment and the community pediatric caregivers. A program has been created to provide this specialized preterm infant/mother outpatient lactation support. The program includes in-home availability of a hospital-grade electric pump and an infant weigh scale and pediatric clinic-based lactation counseling support. Fourteen pediatric practices are included in this study. Seven practices were randomized to intervention and seven were randomized to be controls.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Other: Specialized Preterm Infant/Mother Dyad Lactation SupportFor infants receiving pediatric care at one of the seven intervention practices, mothers will receive the Specialized Preterm Infant/Mother Dyad Lactation Support which includes home equipment and pediatric clinic-lactation support to support lactation for four months post-hospital discharge. |
| Control | No intervention | –For infants receiving pediatric care at one of the seven control practices, mothers will receive standard support. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Any infant discharge to home from the Medical University of South Carolina neonatal services
- Born <35 weeks' gestation
- Mother providing her milk and plans to continue providing her milk for at least 6 months
- The infant's post-discharge pediatric clinic identified by mother as one involved in the study
- The eligible twin will be the first twin discharged from the hospital or, if discharge occurs simultaneously, the infant identified in the hospital as "twin A" will be eligible.
Key exclusion criteria (6 listed)
- Infants with major congenital anomalies
- Infants with anomalies affecting oral intake
- Infants receiving tube feeds at hospital discharge
- Infants receiving parenteral nutrition at hospital discharge
- Triplet or greater pregnancies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Specialized Preterm Infant/Mother Dyad Lactation SupportMother will receive home equipment and pediatric clinic lactation support. | Other | Intervention |
Primary outcome
Preterm infant intake of mother's milk post-hospital discharge measured by survey.
Time frame: 4 months
6 secondary outcomes
Preterm infant breastfeeding post-hospital discharge measured by survey.
Time frame: 4 months
Sustaining preterm infant mother's milk intake post-hospital discharge measured by survey.
Time frame: 6 months
Preterm infant growth post-hospital discharge collected from pediatric clinic medical record.
Time frame: 6 months
Preterm infant re-hospitalization post-hospital discharge collected from pediatric clinic medical record.
Time frame: 6 months
Preterm infant respiratory illness events post-hospital discharge collected from pediatric clinic medical record.
Time frame: 6 months
Preterm infant gastrointestinal illness events post-hospital discharge collected from pediatric clinic medical record.
Time frame: 6 months
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 13 Jun 2018.
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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.
Sarah N Taylor, MD, MSCR principal investigator
Medical University of South Carolina
Questions about this trial
What is this clinical trial studying?
A study testing Specialized Preterm Infant/Mother Dyad Lactation Support in people with Breastfeeding, run by Medical University of South Carolina.
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 5 inclusion and 6 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 13 Jun 2018. 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?
Preterm infant intake of mother's milk post-hospital discharge measured by survey. (time frame: 4 months). 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 13 Jun 2018.