Breast Milk Expression
Conditions
Keywords
Breast milk, lactogenesis stage two, premature infant, insufficient milk supply, breast milk expression
Brief summary
Compelling evidence exists that breast milk helps protect very premature infants from prematurity-specific morbidities. Unfortunately, mothers of premature infants often exhibit delayed lactogenesis stage II (when the milk comes in) and decreased breast milk production. Several studies have linked earlier initiation of breast milk expression following delivery with a greater milk production. However, none conclusively determined the optimal timing of breast milk expression. As a result these mothers continue to struggle with inadequate breast milk production. This study will follow 180 mothers of premature infants for 6 weeks following delivery to test Earlier initiation of breast milk expression following delivery is associated with (1) an earlier lactogenesis stage II, (2) greater volume of breast milk production during the first 6 weeks, (3) improved short-term infant health outcomes and (4) women who deliver at an earlier gestation will have decreased milk production and a later lactogenesis stage II. Following stratification according to the gestational age of the infant (23-27 weeks vs. 28-32 weeks), eligible women will be randomly assigned to one of three groups and instructed to start mechanically expressing their r breasts, either in the first hour, 1-3 hours or 3-6 hours following delivery. The timing of lactogenesis stage II will be documented, and the volume of breast milk produced will continue to be measured for the first 6 weeks following delivery and at discharge. Infant nutritional outcomes will be measured throughout the 6-week study. The impact of the differences in timing of initiation of milk expression following delivery on timing of lactogenesis stage II, milk volume, short term nutritional outcomes, amount of breast milk feedings at discharge, and impact of gestational age on milk volume and lactogenesis stage II will be determined.
Detailed description
Mothers will be randomly assigned to one of three groups. Group 1 will begin pumping their breasts with the assistance of medical or nursing personnel within 60 minutes following delivery. Group 2 will begin pumping their breasts with the assistance of medical or nursing personnel within 1- less than 3 hours following delivery. Group 3 will begin pumping their breasts with the assistance of medical or nursing personnel 3-6 hours following delivery. Mothers will also do the following 1. Complete a log with information about their daily breast pumping sessions for 6 weeks. 2. Bring your breast milk to the neonatal intensive care unit when they visit and the milk will be weighed to determine the volume of milk. 3. Episodes of kangaroo care (placing the infant on your bare chest) will be collected. 4. Receive a call beginning the day after you delivery and then daily until their milk comes in to ask about a feeling of fullness in their breasts. In addition the following will be done 1. If their infant breastfeeds, he/she will be weighed before and after feeding to collect data on how much milk he/she ate from the breast 2. Information regarding infant's weekly breast milk intake and breast milk intake at discharge will be collected
Interventions
BEHAVIORALEarly initiation
Initiation of breast milk expression \<1 hour following delivery.
BEHAVIORALIntermediate expression
Initiation of milk expression 1-\<3 hours following delivery.
BEHAVIORALLate initiation
Initiation of milk expression \>3-6 hours following delivery.
Sponsors
National Institute of Nursing Research (NINR)
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 1\) at least 18 years of age, * 2\) English or Spanish-speaking, * 3\) stated intent to breastfeed, * 4\) anticipating the birth of a very low birth weight infant (≤1500 grams) between 23-32 weeks gestation.
Exclusion criteria
* 1\) known illicit maternal drug use, * 2\) history of breast reduction or augmentation, * 3\) positive HIV status, * 4\) mother not transported to recovery by 45 minutes following delivery or * 5\) infant not expected to live over 2 weeks following delivery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pumped Milk Volume at Day 14 | Day 14 postpartum | Volume of pumped milk on day 14 postpartum |
| Pumped Milk Volume Day 6 | Day 6 postpartum | Volume of pumped milk on Day 6 postpartum |
| Pumped Milk Volume on Day 7 | Day 7 postpartum | Volume of milk pumped on day 7 postpartum |
| Pumped Milk Volume Day 1 | Day 1 postpartum | Volume of pumped milk on day 1 postpartum |
| Pumped Milk Volume on Day 2 | Day 2 postpartum | Volume of breast milk pumped on day 2 postpartum |
| Pumped Milk Volume Day 3 | Day 3 postpartum | Volume of milk pumped on day 3 postpartum |
| Pumped Milk Volume Day 4 | Day 4 postpartum | Volume of pumped milk on Day 4 postpartum |
| Pumped Milk Volume on Day 5 | Day 5 postpartum | Volume of pumped milk on Day 5 postpartum |
| Pumped Milk Volume Day 21 | Day 21 postpartum | Volume of milk pumped on day 21 postpartum |
| Pumped Milk Volume Day 28 | Day 28 postpartum | Volume of milk pumped on day 28 postpartum |
| Pumped Milk Volume on Day 35 | Day 35 postpartum | Volume of milk pumped on day 35 postpartum |
| Pumped Milk Volume on Day 42 | Day 42 postpartum | Volume of milk pumped on day 42 postpartum |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hours From Birth to Onset of Lactogenesis Stage 2 | Hours from birth to onset of lactogenesis stage 2 | Mothers were asked daily concerning a feeling of fullness in their breasts as a measure of onset of lactogenesis stage 2 |
| Days Lactated | birth to approximately 3 months | Days mothers lactated until infant NICU discharge |
| Percentage of Feeds Consisting of Mother's Own Milk Week 1 | Day 1 to 7 | The percentage of feeds consisting of mother's own milk consumed by the participant's infants from day 1-7 |
| Percentage of Feeds Consisting of Mother's Own Milk Week 2 Consumed by Infants | Day 7-14 | The percentage of feeds consisting of mother's own milk consumed by the participants infants from day 7-14 |
| Percentage of Feeds Consisting of Mother's Own Milk Week 3 | Day 14-21 | The percentage of feeds consisting of mother's own milk consumed by the participant's infant from day 14-21 |
| Percentage of Feeds Consisting of Mother's Own Milk Week 4 | Day 21-28 | The percentage of feeds consisting of mother's own milk consumed by the participant's infant from day 21-28 |
| Percentage of Feeds Consisting of Mother's Own Milk Week 5 | Day 28-35 | The percentage of feeds consisting of mother's own milk consumed by the participant's infant from day 28-35 |
| Percentage of Feeds Consisting of Mother's Own Milk Week 6 | Day 35-42 | The percentage of feeds consisting of mother's own milk consumed by the participant's infant from day 35-42 |
| Percentage of Feedings Consisting of Mother's Own Milk at NICU Discharge | 24 hour period prior to NICU discharge | The percentage of feedings consisting of mother's own milk consumed by the participant's infant over the 24 hours period prior to NICU discharge among mothers who continued to lactate |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Early Initiation Initiation of breast milk expression \<1 hour following delivery.
Early initiation: Initiation of breast milk expression \<1 hour following delivery. | 52 |
| Intermediate Expression Initiation of milk expression 1-\<3 hours following delivery.
Intermediate expression: Initiation of milk expression 1-\<3 hours following delivery. | 61 |
| Late Initiation Initiation of milk expression \>3-6 hours following delivery.
Late initiation: Initiation of milk expression \>3-6 hours following delivery. | 55 |
| Total | 168 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 4 | 1 | 3 |
| Overall Study | Withdrawal by Subject | 2 | 0 | 2 |
Baseline characteristics
| Characteristic | Early Initiation | Total | Late Initiation | Intermediate Expression |
|---|---|---|---|---|
| Age, Continuous | 26.4 years STANDARD_DEVIATION 5.4 | 26.9 years STANDARD_DEVIATION 6 | 28.2 years STANDARD_DEVIATION 6.1 | 26.1 years STANDARD_DEVIATION 6.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 18 Participants | 8 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 47 Participants | 150 Participants | 47 Participants | 56 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 3 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 23 Participants | 65 Participants | 19 Participants | 23 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 18 Participants | 7 Participants | 4 Participants |
| Race (NIH/OMB) White | 21 Participants | 82 Participants | 29 Participants | 32 Participants |
| Region of Enrollment United States | 52 participants | 168 participants | 55 participants | 61 participants |
| Sex: Female, Male Female | 52 Participants | 168 Participants | 55 Participants | 61 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 52 | 0 / 61 | 0 / 55 |
| other Total, other adverse events | 0 / 52 | 0 / 61 | 0 / 55 |
| serious Total, serious adverse events | 0 / 52 | 0 / 61 | 0 / 55 |
Outcome results
Primary
Pumped Milk Volume at Day 14
Volume of pumped milk on day 14 postpartum
Time frame: Day 14 postpartum
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Early Initiation | Pumped Milk Volume at Day 14 | 398 mL | Standard Deviation 380 |
| Intermediate Expression | Pumped Milk Volume at Day 14 | 391 mL | Standard Deviation 335 |
| Late Initiation | Pumped Milk Volume at Day 14 | 461 mL | Standard Deviation 352 |
p-value: 0.143Marginalized two part model
p-value: 0.196Marginalized two part model
Primary
Pumped Milk Volume Day 1
Volume of pumped milk on day 1 postpartum
Time frame: Day 1 postpartum
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Early Initiation | Pumped Milk Volume Day 1 | 3 mL | Standard Deviation 3 |
| Intermediate Expression | Pumped Milk Volume Day 1 | 4 mL | Standard Deviation 4 |
| Late Initiation | Pumped Milk Volume Day 1 | 5 mL | Standard Deviation 4 |
p-value: 0.015Marginalized two part model
p-value: 0.339Marginalized two part model
Primary
Pumped Milk Volume Day 21
Volume of milk pumped on day 21 postpartum
Time frame: Day 21 postpartum
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Early Initiation | Pumped Milk Volume Day 21 | 396 mL | Standard Deviation 370 |
| Intermediate Expression | Pumped Milk Volume Day 21 | 377 mL | Standard Deviation 305 |
| Late Initiation | Pumped Milk Volume Day 21 | 447 mL | Standard Deviation 341 |
p-value: 0.185Marginalized two part model
p-value: 0.183Marginalized two part model
Primary
Pumped Milk Volume Day 28
Volume of milk pumped on day 28 postpartum
Time frame: Day 28 postpartum
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Early Initiation | Pumped Milk Volume Day 28 | 332 mL | Standard Deviation 317 |
| Intermediate Expression | Pumped Milk Volume Day 28 | 305 mL | Standard Deviation 262 |
| Late Initiation | Pumped Milk Volume Day 28 | 365 mL | Standard Deviation 275 |
p-value: 0.229Marginalized two part model
p-value: 0.17Marginalized two part model
Primary
Pumped Milk Volume Day 3
Volume of milk pumped on day 3 postpartum
Time frame: Day 3 postpartum
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Early Initiation | Pumped Milk Volume Day 3 | 31 mL | Standard Deviation 30 |
| Intermediate Expression | Pumped Milk Volume Day 3 | 36 mL | Standard Deviation 31 |
| Late Initiation | Pumped Milk Volume Day 3 | 41 mL | Standard Deviation 31 |
p-value: 0.031Marginalized two part model
p-value: 0.298Marginalized two part model
Primary
Pumped Milk Volume Day 4
Volume of pumped milk on Day 4 postpartum
Time frame: Day 4 postpartum
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Early Initiation | Pumped Milk Volume Day 4 | 73 mL | Standard Deviation 70 |
| Intermediate Expression | Pumped Milk Volume Day 4 | 82 mL | Standard Deviation 70 |
| Late Initiation | Pumped Milk Volume Day 4 | 94 mL | Standard Deviation 72 |
p-value: 0.05Marginalized two part model
p-value: 0.27Marginalized 2 part model
Primary
Pumped Milk Volume Day 6
Volume of pumped milk on Day 6 postpartum
Time frame: Day 6 postpartum
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Early Initiation | Pumped Milk Volume Day 6 | 240 mL | Standard Deviation 230 |
| Intermediate Expression | Pumped Milk Volume Day 6 | 253 mL | Standard Deviation 217 |
| Late Initiation | Pumped Milk Volume Day 6 | 293 mL | Standard Deviation 233 |
p-value: 0.094Marginalized two part model
p-value: 0.235Marginalized 2 part model
Primary
Pumped Milk Volume on Day 2
Volume of breast milk pumped on day 2 postpartum
Time frame: Day 2 postpartum
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Early Initiation | Pumped Milk Volume on Day 2 | 11 mL | Standard Deviation 11 |
| Intermediate Expression | Pumped Milk Volume on Day 2 | 13 mL | Standard Deviation 12 |
| Late Initiation | Pumped Milk Volume on Day 2 | 15 mL | Standard Deviation 12 |
p-value: 0.024Marginalized two part model
p-value: 0.317Marginalized two part model
Primary
Pumped Milk Volume on Day 35
Volume of milk pumped on day 35 postpartum
Time frame: Day 35 postpartum
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Early Initiation | Pumped Milk Volume on Day 35 | 234 mL | Standard Deviation 224 |
| Intermediate Expression | Pumped Milk Volume on Day 35 | 209 mL | Standard Deviation 179 |
| Late Initiation | Pumped Milk Volume on Day 35 | 252 mL | Standard Deviation 192 |
p-value: 0.314Marginalized two part model
p-value: 0.162Marginalized two part model
Primary
Pumped Milk Volume on Day 42
Volume of milk pumped on day 42 postpartum
Time frame: Day 42 postpartum
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Early Initiation | Pumped Milk Volume on Day 42 | 139 mL | Standard Deviation 133 |
| Intermediate Expression | Pumped Milk Volume on Day 42 | 120 mL | Standard Deviation 103 |
| Late Initiation | Pumped Milk Volume on Day 42 | 146 mL | Standard Deviation 112 |
p-value: 0.377Marginalized two part model
p-value: 0.149Marginalized two part model
Primary
Pumped Milk Volume on Day 5
Volume of pumped milk on Day 5 postpartum
Time frame: Day 5 postpartum
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Early Initiation | Pumped Milk Volume on Day 5 | 145 mL | Standard Deviation 138 |
| Intermediate Expression | Pumped Milk Volume on Day 5 | 157 mL | Standard Deviation 135 |
| Late Initiation | Pumped Milk Volume on Day 5 | 180 mL | Standard Deviation 138 |
p-value: 0.069Marginalized two part model
p-value: 0.244Marginalized two part model
Primary
Pumped Milk Volume on Day 7
Volume of milk pumped on day 7 postpartum
Time frame: Day 7 postpartum
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Early Initiation | Pumped Milk Volume on Day 7 | 337 mL | Standard Deviation 322 |
| Intermediate Expression | Pumped Milk Volume on Day 7 | 343 mL | Standard Deviation 294 |
| Late Initiation | Pumped Milk Volume on Day 7 | 400 mL | Standard Deviation 305 |
p-value: 0.123Marginalized two part model
p-value: 0.21Marginalized two part model
Secondary
Days Lactated
Days mothers lactated until infant NICU discharge
Time frame: birth to approximately 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Early Initiation | Days Lactated | 45.3 days | Standard Deviation 31.8 |
| Intermediate Expression | Days Lactated | 48.7 days | Standard Deviation 28.2 |
| Late Initiation | Days Lactated | 48.2 days | Standard Deviation 28.3 |
p-value: 0.82ANOVA
Secondary
Hours From Birth to Onset of Lactogenesis Stage 2
Mothers were asked daily concerning a feeling of fullness in their breasts as a measure of onset of lactogenesis stage 2
Time frame: Hours from birth to onset of lactogenesis stage 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Early Initiation | Hours From Birth to Onset of Lactogenesis Stage 2 | 140.5 hours from birth | Standard Deviation 144.7 |
| Intermediate Expression | Hours From Birth to Onset of Lactogenesis Stage 2 | 94.7 hours from birth | Standard Deviation 65 |
| Late Initiation | Hours From Birth to Onset of Lactogenesis Stage 2 | 109 hours from birth | Standard Deviation 98.4 |
p-value: 0.08ANOVA
Secondary
Percentage of Feedings Consisting of Mother's Own Milk at NICU Discharge
The percentage of feedings consisting of mother's own milk consumed by the participant's infant over the 24 hours period prior to NICU discharge among mothers who continued to lactate
Time frame: 24 hour period prior to NICU discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Early Initiation | Percentage of Feedings Consisting of Mother's Own Milk at NICU Discharge | 82 Percent | Standard Deviation 30.8 |
| Intermediate Expression | Percentage of Feedings Consisting of Mother's Own Milk at NICU Discharge | 80 Percent | Standard Deviation 31.2 |
| Late Initiation | Percentage of Feedings Consisting of Mother's Own Milk at NICU Discharge | 90 Percent | Standard Deviation 20 |
p-value: 0.36Chi-squared
Secondary
Percentage of Feeds Consisting of Mother's Own Milk Week 1
The percentage of feeds consisting of mother's own milk consumed by the participant's infants from day 1-7
Time frame: Day 1 to 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Early Initiation | Percentage of Feeds Consisting of Mother's Own Milk Week 1 | 71.7 percent | Standard Deviation 42.1 |
| Intermediate Expression | Percentage of Feeds Consisting of Mother's Own Milk Week 1 | 69.2 percent | Standard Deviation 43.4 |
| Late Initiation | Percentage of Feeds Consisting of Mother's Own Milk Week 1 | 81.9 percent | Standard Deviation 36.3 |
p-value: 0.22Chi-squared
Secondary
Percentage of Feeds Consisting of Mother's Own Milk Week 2 Consumed by Infants
The percentage of feeds consisting of mother's own milk consumed by the participants infants from day 7-14
Time frame: Day 7-14
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Early Initiation | Percentage of Feeds Consisting of Mother's Own Milk Week 2 Consumed by Infants | 65.7 percent | Standard Deviation 45.1 |
| Intermediate Expression | Percentage of Feeds Consisting of Mother's Own Milk Week 2 Consumed by Infants | 66.7 percent | Standard Deviation 44.1 |
| Late Initiation | Percentage of Feeds Consisting of Mother's Own Milk Week 2 Consumed by Infants | 70.2 percent | Standard Deviation 45.6 |
p-value: 0.87Chi-squared
Secondary
Percentage of Feeds Consisting of Mother's Own Milk Week 3
The percentage of feeds consisting of mother's own milk consumed by the participant's infant from day 14-21
Time frame: Day 14-21
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Early Initiation | Percentage of Feeds Consisting of Mother's Own Milk Week 3 | 55.7 percent | Standard Deviation 48.5 |
| Intermediate Expression | Percentage of Feeds Consisting of Mother's Own Milk Week 3 | 59.6 percent | Standard Deviation 48.7 |
| Late Initiation | Percentage of Feeds Consisting of Mother's Own Milk Week 3 | 70.2 percent | Standard Deviation 45.1 |
p-value: 0.27Chi-squared
Secondary
Percentage of Feeds Consisting of Mother's Own Milk Week 4
The percentage of feeds consisting of mother's own milk consumed by the participant's infant from day 21-28
Time frame: Day 21-28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Early Initiation | Percentage of Feeds Consisting of Mother's Own Milk Week 4 | 57.5 percent | Standard Deviation 48 |
| Intermediate Expression | Percentage of Feeds Consisting of Mother's Own Milk Week 4 | 62.3 percent | Standard Deviation 46.4 |
| Late Initiation | Percentage of Feeds Consisting of Mother's Own Milk Week 4 | 64.5 percent | Standard Deviation 47.7 |
p-value: 0.77Chi-squared
Secondary
Percentage of Feeds Consisting of Mother's Own Milk Week 5
The percentage of feeds consisting of mother's own milk consumed by the participant's infant from day 28-35
Time frame: Day 28-35
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Early Initiation | Percentage of Feeds Consisting of Mother's Own Milk Week 5 | 51.8 percent | Standard Deviation 49 |
| Intermediate Expression | Percentage of Feeds Consisting of Mother's Own Milk Week 5 | 54.3 percent | Standard Deviation 48.1 |
| Late Initiation | Percentage of Feeds Consisting of Mother's Own Milk Week 5 | 65.6 percent | Standard Deviation 46.5 |
p-value: 0.31Chi-squared
Secondary
Percentage of Feeds Consisting of Mother's Own Milk Week 6
The percentage of feeds consisting of mother's own milk consumed by the participant's infant from day 35-42
Time frame: Day 35-42
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Early Initiation | Percentage of Feeds Consisting of Mother's Own Milk Week 6 | 51.1 percent | Standard Deviation 48.9 |
| Intermediate Expression | Percentage of Feeds Consisting of Mother's Own Milk Week 6 | 53.9 percent | Standard Deviation 49.7 |
| Late Initiation | Percentage of Feeds Consisting of Mother's Own Milk Week 6 | 56 percent | Standard Deviation 48.6 |
p-value: 0.9Chi-squared