Preterm BirthNCT04006509
Prenatal Breast Pump Education of Mothers and Their Support Person
A study testing Prenatally Delivered Lactation Educational Program in people with Preterm Birth and Breast Feeding, run by University of Florida at 1 site in United States.
Trial summary
The study will follow a prospective cohort of racially and economically diverse mothers of premature infants for 3 weeks following delivery to test whether antenatal education of the support person of mothers may decrease time to initiation of breast pumping, decrease time to lactogenesis stage II and increase breast… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth, Breast Feeding
- What is being tested?
- Prenatally Delivered Lactation Educational Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2018to 4 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- English speaking
- stated intent to breastfeed
- anticipating the birth of a premature infant < 35 weeks gestation.
Who cannot join
- known illicit maternal drug use
- history of breast reduction or augmentation
- positive HIV status
- infant not expected to live over 2 weeks following delivery.
Trial locations and contacts
1 site in 1 country.
United States1 site
UF Health at the University of Florida
Gainesville, Florida, 32610
About this study
Official title: Prenatal Breast Pumping Education of Mothers and Their Support Person
The study will follow a prospective cohort of racially and economically diverse mothers of premature infants for 3 weeks following delivery to test whether antenatal education of the support person of mothers may decrease time to initiation of breast pumping, decrease time to lactogenesis stage II and increase breast milk production.
Read the detailed description
Compelling evidence exists that breast milk helps protect premature infants from prematurity-specific morbidities, including feeding intolerance, late onset sepsis, and necrotizing enterocolitis. Unfortunately, mothers of VLBW infants often exhibit delayed lactogenesis stage II (when the milk "comes in") and inadequate breast milk production. Earlier initiation of breast milk expression following delivery is associated with increased lactation success. However, lack of nursing time and lack of hospital personal are significant barriers to the early initiation of milk expression in this population. The proposed study will follow a prospective cohort of racially and economically diverse mothers of premature infants for 3 weeks following delivery to test 1 primary aim and 1 secondary aim. Aim 1: will evaluate the feasibility of antenatal BM pumping education for SPs of mothers of preterm infants. Issues related to recruitment, randomization acceptance of the intervention, and refinement of the education materials and process will be scrutinized. Aim 2 will estimate variability of outcome measurements and effect sizes needed to calculate the sample size for a subsequent larger, adequately powered, randomized clinical trial. Eligible women and their SP will be randomly assigned to one of two groups. Group 1 will receive a prenatally delivered lactation educational program including video recordings, a demonstration of how the pump works and will have a breast pump available in their room. The volume of breast milk produced, timing of lactation stage II, duration of lactation and stress during initial expression will be measured. In addition, breast milk sodium levels will be analyzed on Day 1-7, Day 14 and 21.
- Conditions
- Preterm Birth, Breast Feeding
- Being tested
- Prenatally Delivered Lactation Educational Program
- Keywords
- preterm breast milk
- Medical subject headings
- Premature Birth, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prenatally Delivered Lactation Educational ProgramBehavioural
Also called Antenatal Education
The support person (SP) of mothers at risk for preterm birth will be educated on how to use a breast pump and instructions regarding breast milk expression and have a pump in their hospital room
| Study group | Role | What they receive |
|---|---|---|
| Antenatal Education Group | Experimental | Patients will receive a prenatally delivered lactation educational program. Receives: Behavioral: Prenatally Delivered Lactation Educational Program |
| Standard of Care Group | No intervention | Patients will receive standard of care and not a prenatally delivered lactation educational program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Onset of Lactogenesis Stage II Through Volume Attainment
Time in hours until mothers pump at least 20 mL of milk in 2 consecutive pumping sessions
Measured: Up to 96 Hours
Secondary outcomes (10)
Breast Milk Production on Day 1
Volume of breast milk produced from 0-24 hours postpartum
Measured: 0-24 hours postpartum
Time to Breast Pumping Initiation
Time to mothers beginning to pump breasts after delivery
Measured: first 24 hours after delivery
Breast Milk Production Day 2
Volume of breast milk produced on day 2 postpartum
Measured: Day 2 postpartum
Milk Production Day 3
Volume of milk produced on Day 3 postpartum
Measured: 3 days postpartum
Breast Milk Production Day 4
Volume of breast milk produced on Day 4 postpartum
Measured: Day 4 postpartum
Breast Milk Production on Day 5
Volume of breast milk produced on Day 5 postpartum
Measured: Day 5 postpartum
Breast Milk Production Day 6
Volume of breast milk produced on Day 6 postpartum
Measured: Day 6 postpartum
Breast Milk Production Day 7
Volume of milk produced on Day 7 postpartum
Measured: Day 7 postpartum
Breast Milk Production Day 14
Volume of breast milk produced on Day 14 postpartum
Measured: Day 14 postpartum
Breast Milk Production Day 21
Volume of breast milk produced on Day 21 postpartum
Measured: 21 days postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start6 Nov 2018
- Primary completion4 May 2022
- Study completion4 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leslie A Parker, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04006509
- Sponsor's protocol ID
- P0081761
- Other IDs
- IRB201400318
- Status last verified
- May 2024
- First submitted
- 1 Jul 2019
- Last updated
- 21 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Parker LA, Bendixen M, Sullivan S, Cacho N, Mueller M. Antepartum Breast Pump Education for Mothers and Their Support Person: Effect on Time to First Expression and Lactation Outcomes-A Randomized Controlled Pilot Study. Breastfeed Med. 2022 May;17(5):437-445. doi: 10.1089/bfm.2021.0275. Epub 2022 Apr 26.
PubMed 35475721
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prenatal Breast Pumping Education of Mothers and Their Support Person
- ClinicalTrials.gov ID
- NCT04006509
- Acronym / sponsor ID
- P0081761
- Conditions
- Preterm Birth, Breast Feeding
- Keywords
- preterm breast milk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 6 Nov 2018 (actual)
- Primary completion
- 4 May 2022 (actual)
- Study completion
- 4 May 2022 (actual)
- First posted
- 5 Jul 2019 (actual)
- Results
- Posted 21 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will follow a prospective cohort of racially and economically diverse mothers of premature infants for 3 weeks following delivery to test whether antenatal education of the support person of mothers may decrease time to initiation of breast pumping, decrease time to lactogenesis stage II and increase breast milk production.
Detailed description
Compelling evidence exists that breast milk helps protect premature infants from prematurity-specific morbidities, including feeding intolerance, late onset sepsis, and necrotizing enterocolitis. Unfortunately, mothers of VLBW infants often exhibit delayed lactogenesis stage II (when the milk "comes in") and inadequate breast milk production. Earlier initiation of breast milk expression following delivery is associated with increased lactation success. However, lack of nursing time and lack of hospital personal are significant barriers to the early initiation of milk expression in this population. The proposed study will follow a prospective cohort of racially and economically diverse mothers of premature infants for 3 weeks following delivery to test 1 primary aim and 1 secondary aim. Aim 1: will evaluate the feasibility of antenatal BM pumping education for SPs of mothers of preterm infants. Issues related to recruitment, randomization acceptance of the intervention, and refinement of the education materials and process will be scrutinized. Aim 2 will estimate variability of outcome measurements and effect sizes needed to calculate the sample size for a subsequent larger, adequately powered, randomized clinical trial. Eligible women and their SP will be randomly assigned to one of two groups. Group 1 will receive a prenatally delivered lactation educational program including video recordings, a demonstration of how the pump works and will have a breast pump available in their room. The volume of breast milk produced, timing of lactation stage II, duration of lactation and stress during initial expression will be measured. In addition, breast milk sodium levels will be analyzed on Day 1-7, Day 14 and 21.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antenatal Education Group | Experimental | Behavioral: Prenatally Delivered Lactation Educational ProgramPatients will receive a prenatally delivered lactation educational program. |
| Standard of Care Group | No intervention | –Patients will receive standard of care and not a prenatally delivered lactation educational program. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- English speaking
- stated intent to breastfeed
- anticipating the birth of a premature infant < 35 weeks gestation.
Key exclusion criteria (4 listed)
- known illicit maternal drug use
- history of breast reduction or augmentation
- positive HIV status
- infant not expected to live over 2 weeks following delivery.
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 |
|---|---|---|
| Prenatally Delivered Lactation Educational ProgramAlso: Antenatal EducationThe support person (SP) of mothers at risk for preterm birth will be educated on how to use a breast pump and instructions regarding breast milk expression and have a pump in their hospital room | Behavioural | Antenatal Education Group |
Primary outcome
Onset of Lactogenesis Stage II Through Volume Attainment
Time frame: Up to 96 Hours
Time in hours until mothers pump at least 20 mL of milk in 2 consecutive pumping sessions
10 secondary outcomes
Breast Milk Production on Day 1
Time frame: 0-24 hours postpartum
Time to Breast Pumping Initiation
Time frame: first 24 hours after delivery
Breast Milk Production Day 2
Time frame: Day 2 postpartum
Milk Production Day 3
Time frame: 3 days postpartum
Breast Milk Production Day 4
Time frame: Day 4 postpartum
Breast Milk Production on Day 5
Time frame: Day 5 postpartum
Breast Milk Production Day 6
Time frame: Day 6 postpartum
Breast Milk Production Day 7
Time frame: Day 7 postpartum
Breast Milk Production Day 14
Time frame: Day 14 postpartum
Breast Milk Production Day 21
Time frame: 21 days postpartum
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35475721Parker LA, Bendixen M, Sullivan S, Cacho N, Mueller M. Antepartum Breast Pump Education for Mothers and Their Support Person: Effect on Time to First Expression and Lactation Outcomes-A Randomized Controlled Pilot Study. Breastfeed Med. 2022 May;17(5):437-445. doi: 10.1089/bfm.2021.0275. Epub 2022 Apr 26.
- Individual participant dataSharing planned: No
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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.
Leslie A Parker principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prenatally Delivered Lactation Educational Program in people with Preterm Birth and Breast Feeding, run by University of Florida 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 3 inclusion and 4 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 21 May 2024. 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?
Yes. Results are posted in the registry (first posted 21 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Onset of Lactogenesis Stage II Through Volume Attainment (time frame: Up to 96 Hours). 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 NCT04006509, 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 21 May 2024.