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| ID | Type | Description | Link |
|---|---|---|---|
| IRB201400318 | Other Identifier | University of Florida |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antenatal Education Group | Experimental | Patients 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prenatally Delivered Lactation Educational Program | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 96 Hours |
| Measure | Description | Time Frame |
|---|---|---|
| Breast Milk Production on Day 1 | Volume of breast milk produced from 0-24 hours postpartum | 0-24 hours postpartum |
| Time to Breast Pumping Initiation | Time to mothers beginning to pump breasts after delivery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leslie A Parker | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UF Health at the University of Florida | Gainesville | Florida | 32610 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35475721 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Antenatal Education Group | Patients will receive a prenatally delivered lactation educational program. Prenatally Delivered Lactation Educational Program: 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 |
| FG001 | Standard of Care Group | Patients will receive standard of care and not a prenatally delivered lactation educational program. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Antenatal Education Group | Patients will receive a prenatally delivered lactation educational program. Prenatally Delivered Lactation Educational Program: 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | 95% Confidence Interval | hours | Up to 96 Hours |
|
21 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Antenatal Education Group | Patients will receive a prenatally delivered lactation educational program. Prenatally Delivered Lactation Educational Program: 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Leslie A. Parker | University of Florida | 352 273 6384 | parkela@ufl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 16, 2019 | Nov 28, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 19, 2011 | Nov 28, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D064186 | Prenatal Education |
| ID | Term |
|---|---|
| D010353 | Patient Education as Topic |
| D006266 | Health Education |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
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|
| first 24 hours after delivery |
| Breast Milk Production Day 2 | Volume of breast milk produced on day 2 postpartum | Day 2 postpartum |
| Milk Production Day 3 | Volume of milk produced on Day 3 postpartum | 3 days postpartum |
| Breast Milk Production Day 4 | Volume of breast milk produced on Day 4 postpartum | Day 4 postpartum |
| Breast Milk Production on Day 5 | Volume of breast milk produced on Day 5 postpartum | Day 5 postpartum |
| Breast Milk Production Day 6 | Volume of breast milk produced on Day 6 postpartum | Day 6 postpartum |
| Breast Milk Production Day 7 | Volume of milk produced on Day 7 postpartum | Day 7 postpartum |
| Breast Milk Production Day 14 | Volume of breast milk produced on Day 14 postpartum | Day 14 postpartum |
| Breast Milk Production Day 21 | Volume of breast milk produced on Day 21 postpartum | 21 days postpartum |
| BG001 |
| Standard of Care Group |
Patients will receive standard of care and not a prenatally delivered lactation educational program. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Secondary | Breast Milk Production on Day 1 | Volume of breast milk produced from 0-24 hours postpartum | Posted | Median | Standard Deviation | mL | 0-24 hours postpartum |
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| Secondary | Time to Breast Pumping Initiation | Time to mothers beginning to pump breasts after delivery | Posted | Mean | Standard Deviation | Hours | first 24 hours after delivery |
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| Secondary | Breast Milk Production Day 2 | Volume of breast milk produced on day 2 postpartum | Posted | Mean | Standard Deviation | mL | Day 2 postpartum |
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| Secondary | Milk Production Day 3 | Volume of milk produced on Day 3 postpartum | Posted | Mean | Standard Deviation | mL | 3 days postpartum |
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| Secondary | Breast Milk Production Day 4 | Volume of breast milk produced on Day 4 postpartum | Posted | Mean | Standard Deviation | mL | Day 4 postpartum |
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| Secondary | Breast Milk Production on Day 5 | Volume of breast milk produced on Day 5 postpartum | Posted | Mean | Standard Deviation | mL | Day 5 postpartum |
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| Secondary | Breast Milk Production Day 6 | Volume of breast milk produced on Day 6 postpartum | Posted | Mean | Standard Deviation | mL | Day 6 postpartum |
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| Secondary | Breast Milk Production Day 7 | Volume of milk produced on Day 7 postpartum | Posted | Mean | Standard Deviation | mL | Day 7 postpartum |
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| Secondary | Breast Milk Production Day 14 | Volume of breast milk produced on Day 14 postpartum | Posted | Mean | Standard Deviation | mL | Day 14 postpartum |
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| Secondary | Breast Milk Production Day 21 | Volume of breast milk produced on Day 21 postpartum | Posted | Mean | Standard Deviation | mL | 21 days postpartum |
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| 0 |
| 36 |
| 0 |
| 36 |
| 0 |
| 36 |
| EG001 | Standard of Care Group | Patients will receive standard of care and not a prenatally delivered lactation educational program. | 0 | 25 | 0 | 25 | 0 | 25 |
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| D000091642 | Urogenital Diseases |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D005159 |
| Health Care Facilities Workforce and Services |