An interventional study of Prenatally Delivered Lactation Educational Program in Preterm Birth and Breast Feeding, sponsored by University of Florida. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-21.
Sponsored by University of Florida · Not applicable, Interventional, and Prevention
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.
2,610 studies on the registry are indexed under Premature Birth; 507 are open to participants now.
This study's enrollment of 90 is close to the median of 84 across 1,722 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →University of Florida is the lead sponsor of 1,285 studies on the registry; 199 are open to participants now.
Of its 177 completed or terminated interventional studies of FDA-regulated products, 141 (80%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients will receive a prenatally delivered lactation educational program.
Behavioral: Prenatally Delivered Lactation Educational Program
Patients will receive standard of care and not a 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
Also known as: Antenatal Education
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
Time frame: Up to 96 Hours
Breast Milk Production on Day 1
Volume of breast milk produced from 0-24 hours postpartum
Time frame: 0-24 hours postpartum
Time to Breast Pumping Initiation
Time to mothers beginning to pump breasts after delivery
Time frame: first 24 hours after delivery
Breast Milk Production Day 2
Volume of breast milk produced on day 2 postpartum
Time frame: Day 2 postpartum
Milk Production Day 3
Volume of milk produced on Day 3 postpartum
Time frame: 3 days postpartum
Breast Milk Production Day 4
Volume of breast milk produced on Day 4 postpartum
Time frame: Day 4 postpartum
Breast Milk Production on Day 5
Volume of breast milk produced on Day 5 postpartum
Time frame: Day 5 postpartum
Breast Milk Production Day 6
Volume of breast milk produced on Day 6 postpartum
Time frame: Day 6 postpartum
Breast Milk Production Day 7
Volume of milk produced on Day 7 postpartum
Time frame: Day 7 postpartum
Breast Milk Production Day 14
Volume of breast milk produced on Day 14 postpartum
Time frame: Day 14 postpartum
Breast Milk Production Day 21
Volume of breast milk produced on Day 21 postpartum
Time frame: 21 days postpartum
| Milestone | Antenatal Education Group | Standard of Care Group |
|---|---|---|
| Started | 49 | 25 |
| Completed | 36 | 25 |
| Not completed | 13 | 0 |
Time in hours until mothers pump at least 20 mL of milk in 2 consecutive pumping sessions
| hours | Antenatal Education Group | Standard of Care Group |
|---|---|---|
| Onset of Lactogenesis Stage II Through Volume Attainment | 84.8 (58.8 to 102.6) | 81 (61.3 to 101.3) |
Volume of breast milk produced from 0-24 hours postpartum
| mL | Antenatal Education Group | Standard of Care Group |
|---|---|---|
| Breast Milk Production on Day 1 | 15.3 ± 16.5 | 24.3 ± 28.1 |
Time to mothers beginning to pump breasts after delivery
| Hours | Antenatal Education Group | Standard of Care Group |
|---|---|---|
| Time to Breast Pumping Initiation | 4 ± 3.5 | 3.8 ± 3.4 |
Volume of breast milk produced on day 2 postpartum
| mL | Antenatal Education Group | Standard of Care Group |
|---|---|---|
| Breast Milk Production Day 2 | 32.7 ± 35.6 | 39.5 ± 43.7 |
Volume of milk produced on Day 3 postpartum
| mL | Antenatal Education Group | Standard of Care Group |
|---|---|---|
| Milk Production Day 3 | 55.88 ± 57.9 | 59.7 ± 58 |
Volume of breast milk produced on Day 4 postpartum
| mL | Antenatal Education Group | Standard of Care Group |
|---|---|---|
| Breast Milk Production Day 4 | 101.8 ± 126.6 | 97.4 ± 87.2 |
Volume of breast milk produced on Day 5 postpartum
| mL | Antenatal Education Group | Standard of Care Group |
|---|---|---|
| Breast Milk Production on Day 5 | 149.9 ± 167.4 | 138.5 ± 113.2 |
Volume of breast milk produced on Day 6 postpartum
| mL | Antenatal Education Group | Standard of Care Group |
|---|---|---|
| Breast Milk Production Day 6 | 245.3 ± 317.9 | 266.8 ± 300.1 |
Volume of milk produced on Day 7 postpartum
| mL | Antenatal Education Group | Standard of Care Group |
|---|---|---|
| Breast Milk Production Day 7 | 345 ± 558.4 | 361.9 ± 342.3 |
Volume of breast milk produced on Day 14 postpartum
| mL | Antenatal Education Group | Standard of Care Group |
|---|---|---|
| Breast Milk Production Day 14 | 431 ± 416.7 | 428 ± 349.9 |
Volume of breast milk produced on Day 21 postpartum
| mL | Antenatal Education Group | Standard of Care Group |
|---|---|---|
| Breast Milk Production Day 21 | 725 ± 1070.1 | 573.9 ± 402.1 |
Collected over 21 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Antenatal Education Group | 0/36 (0%) | 0/36 (0%) | 0/36 (0%) |
| Standard of Care Group | 0/25 (0%) | 0/25 (0%) | 0/25 (0%) |
| Age, Continuous(years) | Antenatal Education Group | Standard of Care Group | Total |
|---|---|---|---|
| Mean | 27.2 ± 6.4 | 29 ± 6 | 28 ± 6.1 |
| Sex: Female, Male(Participants) | Antenatal Education Group | Standard of Care Group | Total |
|---|---|---|---|
| Female | 36 | 25 | 61 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Antenatal Education Group | Standard of Care Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 22 | 14 | 36 |
| White | 13 | 11 | 24 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Ran from Nov 2018 to primary completion in May 2022, 41 months.
Results were first posted in May 2024, 2 years after primary completion.
Of 753 non-industry interventional studies with no phase under Premature Birth, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's 41 months is above that.
Counting every sponsor, half of 775 studies reached it within 24 months; a quarter within 12 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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