Breast Feeding, Preterm Birth
Conditions
Keywords
preterm breast milk
Brief 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 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.
Interventions
BEHAVIORALPrenatally 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
Sponsors
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* English speaking * stated intent to breastfeed * anticipating the birth of a premature infant \< 35 weeks gestation.
Exclusion criteria
* known illicit maternal drug use * history of breast reduction or augmentation * positive HIV status * infant not expected to live over 2 weeks following delivery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Onset of Lactogenesis Stage II Through Volume Attainment | Up to 96 Hours | Time in hours until mothers pump at least 20 mL of milk in 2 consecutive pumping sessions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Breast Pumping Initiation | first 24 hours after delivery | Time to mothers beginning to pump breasts after delivery |
| Breast Milk Production Day 2 | Day 2 postpartum | Volume of breast milk produced on day 2 postpartum |
| Milk Production Day 3 | 3 days postpartum | Volume of milk produced on Day 3 postpartum |
| Breast Milk Production Day 4 | Day 4 postpartum | Volume of breast milk produced on Day 4 postpartum |
| Breast Milk Production on Day 1 | 0-24 hours postpartum | Volume of breast milk produced from 0-24 hours postpartum |
| Breast Milk Production Day 6 | Day 6 postpartum | Volume of breast milk produced on Day 6 postpartum |
| Breast Milk Production Day 7 | Day 7 postpartum | Volume of milk produced on Day 7 postpartum |
| Breast Milk Production Day 14 | Day 14 postpartum | Volume of breast milk produced on Day 14 postpartum |
| Breast Milk Production Day 21 | 21 days postpartum | Volume of breast milk produced on Day 21 postpartum |
| Breast Milk Production on Day 5 | Day 5 postpartum | Volume of breast milk produced on Day 5 postpartum |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 36 |
| Standard of Care Group Patients will receive standard of care and not a prenatally delivered lactation educational program. | 25 |
| Total | 61 |
Baseline characteristics
| Characteristic | Standard of Care Group | Total | Antenatal Education Group |
|---|---|---|---|
| Age, Continuous | 29 years STANDARD_DEVIATION 6 | 28 years STANDARD_DEVIATION 6.1 | 27.2 years STANDARD_DEVIATION 6.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 36 Participants | 22 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 11 Participants | 24 Participants | 13 Participants |
| Sex: Female, Male Female | 25 Participants | 61 Participants | 36 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 36 | 0 / 25 |
| other Total, other adverse events | 0 / 36 | 0 / 25 |
| serious Total, serious adverse events | 0 / 36 | 0 / 25 |
Outcome results
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
Time frame: Up to 96 Hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Antenatal Education Group | Onset of Lactogenesis Stage II Through Volume Attainment | 84.8 hours |
| Standard of Care Group | Onset of Lactogenesis Stage II Through Volume Attainment | 81 hours |
p-value: 0.985Wilcoxon (Mann-Whitney)
Secondary
Breast Milk Production Day 14
Volume of breast milk produced on Day 14 postpartum
Time frame: Day 14 postpartum
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Antenatal Education Group | Breast Milk Production Day 14 | 431 mL | Standard Deviation 416.7 |
| Standard of Care Group | Breast Milk Production Day 14 | 428 mL | Standard Deviation 349.9 |
p-value: 0.77Marginalized Two-Part Model
Secondary
Breast Milk Production Day 2
Volume of breast milk produced on day 2 postpartum
Time frame: Day 2 postpartum
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Antenatal Education Group | Breast Milk Production Day 2 | 32.7 mL | Standard Deviation 35.6 |
| Standard of Care Group | Breast Milk Production Day 2 | 39.5 mL | Standard Deviation 43.7 |
p-value: 0.743Marginal Two-Part Model
Secondary
Breast Milk Production Day 21
Volume of breast milk produced on Day 21 postpartum
Time frame: 21 days postpartum
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Antenatal Education Group | Breast Milk Production Day 21 | 725 mL | Standard Deviation 1070.1 |
| Standard of Care Group | Breast Milk Production Day 21 | 573.9 mL | Standard Deviation 402.1 |
p-value: 0.237Marginalized Two-Part Model
Secondary
Breast Milk Production Day 4
Volume of breast milk produced on Day 4 postpartum
Time frame: Day 4 postpartum
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Antenatal Education Group | Breast Milk Production Day 4 | 101.8 mL | Standard Deviation 126.6 |
| Standard of Care Group | Breast Milk Production Day 4 | 97.4 mL | Standard Deviation 87.2 |
p-value: 0.107Marginalized Two-Part Model
Secondary
Breast Milk Production Day 6
Volume of breast milk produced on Day 6 postpartum
Time frame: Day 6 postpartum
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Antenatal Education Group | Breast Milk Production Day 6 | 245.3 mL | Standard Deviation 317.9 |
| Standard of Care Group | Breast Milk Production Day 6 | 266.8 mL | Standard Deviation 300.1 |
p-value: 0.871Marginalized Two-Part Model
Secondary
Breast Milk Production Day 7
Volume of milk produced on Day 7 postpartum
Time frame: Day 7 postpartum
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Antenatal Education Group | Breast Milk Production Day 7 | 345 mL | Standard Deviation 558.4 |
| Standard of Care Group | Breast Milk Production Day 7 | 361.9 mL | Standard Deviation 342.3 |
p-value: 0.376Marginalized Two-Part Model
Secondary
Breast Milk Production on Day 1
Volume of breast milk produced from 0-24 hours postpartum
Time frame: 0-24 hours postpartum
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Antenatal Education Group | Breast Milk Production on Day 1 | 15.3 mL | Standard Deviation 16.5 |
| Standard of Care Group | Breast Milk Production on Day 1 | 24.3 mL | Standard Deviation 28.1 |
p-value: 0.539Marginal Two-Part Model
Secondary
Breast Milk Production on Day 5
Volume of breast milk produced on Day 5 postpartum
Time frame: Day 5 postpartum
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Antenatal Education Group | Breast Milk Production on Day 5 | 149.9 mL | Standard Deviation 167.4 |
| Standard of Care Group | Breast Milk Production on Day 5 | 138.5 mL | Standard Deviation 113.2 |
p-value: 0.687Marginalized Two-Part Model
Secondary
Milk Production Day 3
Volume of milk produced on Day 3 postpartum
Time frame: 3 days postpartum
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Antenatal Education Group | Milk Production Day 3 | 55.88 mL | Standard Deviation 57.9 |
| Standard of Care Group | Milk Production Day 3 | 59.7 mL | Standard Deviation 58 |
p-value: 0.886Marginalized Two-Part Model
Secondary
Time to Breast Pumping Initiation
Time to mothers beginning to pump breasts after delivery
Time frame: first 24 hours after delivery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Antenatal Education Group | Time to Breast Pumping Initiation | 4 Hours | Standard Deviation 3.5 |
| Standard of Care Group | Time to Breast Pumping Initiation | 3.8 Hours | Standard Deviation 3.4 |
p-value: 0.959Wilcoxon (Mann-Whitney)