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| ID | Type | Description | Link |
|---|---|---|---|
| 1R15NR013566-01A1 | U.S. NIH Grant/Contract | View source | |
| IRB201200071 | Other Identifier | Univeristy of Florida |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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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.
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
In addition the following will be done
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early initiation | Experimental | Initiation of breast milk expression <1 hour following delivery. |
|
| Intermediate expression | Experimental | Initiation of milk expression 1-<3 hours following delivery. |
|
| Late initiation | Other | Initiation of milk expression >3-6 hours following delivery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early initiation | Behavioral | Initiation of breast milk expression <1 hour following delivery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pumped Milk Volume Day 1 | Volume of pumped milk on day 1 postpartum | Day 1 postpartum |
| Pumped Milk Volume on Day 2 | Volume of breast milk pumped on day 2 postpartum | Day 2 postpartum |
| Pumped Milk Volume Day 3 | Volume of milk pumped on day 3 postpartum | Day 3 postpartum |
| Pumped Milk Volume Day 4 | Volume of pumped milk on Day 4 postpartum | Day 4 postpartum |
| Pumped Milk Volume on Day 5 | Volume of pumped milk on Day 5 postpartum | Day 5 postpartum |
| Pumped Milk Volume Day 6 | Volume of pumped milk on Day 6 postpartum | Day 6 postpartum |
| Pumped Milk Volume on Day 7 | Volume of milk pumped on day 7 postpartum | Day 7 postpartum |
| Pumped Milk Volume at Day 14 | Volume of pumped milk on day 14 postpartum | Day 14 postpartum |
| Pumped Milk Volume Day 21 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Hours from birth to onset of lactogenesis stage 2 |
| Days Lactated |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leslie A Parker, PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida Shands | Gainesville | Florida | 32605 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33913765 | Derived | Parker LA, Sullivan S, Cacho N, Krueger C, Mueller M. Effect of Postpartum Depo Medroxyprogesterone Acetate on Lactation in Mothers of Very Low-Birth-Weight Infants. Breastfeed Med. 2021 Oct;16(10):835-842. doi: 10.1089/bfm.2020.0336. Epub 2021 Apr 28. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Early Initiation | Initiation of breast milk expression <1 hour following delivery. Early initiation: Initiation of breast milk expression <1 hour following delivery. |
| FG001 | Intermediate Expression | Initiation of milk expression 1-<3 hours following delivery. Intermediate expression: Initiation of milk expression 1-<3 hours following delivery. |
| FG002 | Late Initiation | Initiation of milk expression >3-6 hours following delivery. Late initiation: Initiation of milk expression >3-6 hours following delivery. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Early Initiation | Initiation of breast milk expression <1 hour following delivery. Early initiation: Initiation of breast milk expression <1 hour following delivery. |
| BG001 | Intermediate Expression |
| 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 | Pumped Milk Volume Day 1 | Volume of pumped milk on day 1 postpartum | Posted | Least Squares Mean | Standard Deviation | mL | Day 1 postpartum |
|
6 weeks
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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 | Early Initiation | Initiation of breast milk expression <1 hour following delivery. Early initiation: Initiation of breast milk expression <1 hour following delivery. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Leslie Parker | University of Florida | 352 215 9360 | 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 | Jan 8, 2014 | Jan 20, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D061186 | Breast Milk Expression |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D007752 | Obstetric Labor, Premature |
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| Intermediate expression | Behavioral | Initiation of milk expression 1-<3 hours following delivery. |
|
|
| Late initiation | Behavioral | Initiation of milk expression >3-6 hours following delivery. |
|
|
Volume of milk pumped on day 21 postpartum |
| Day 21 postpartum |
| Pumped Milk Volume Day 28 | Volume of milk pumped on day 28 postpartum | Day 28 postpartum |
| Pumped Milk Volume on Day 35 | Volume of milk pumped on day 35 postpartum | Day 35 postpartum |
| Pumped Milk Volume on Day 42 | Volume of milk pumped on day 42 postpartum | Day 42 postpartum |
Days mothers lactated until infant NICU discharge
| birth to approximately 3 months |
| 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 | Day 1 to 7 |
| 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 | Day 7-14 |
| 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 | Day 14-21 |
| 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 | Day 21-28 |
| 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 | Day 28-35 |
| 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 | Day 35-42 |
| 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 | 24 hour period prior to NICU discharge |
Initiation of milk expression 1-<3 hours following delivery.
Intermediate expression: Initiation of milk expression 1-<3 hours following delivery.
| BG002 | Late Initiation | Initiation of milk expression >3-6 hours following delivery. Late initiation: Initiation of milk expression >3-6 hours following delivery. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Initiation of milk expression >3-6 hours following delivery. Late initiation: Initiation of milk expression >3-6 hours following delivery. |
|
|
|
| Primary | Pumped Milk Volume on Day 2 | Volume of breast milk pumped on day 2 postpartum | Posted | Least Squares Mean | Standard Deviation | mL | Day 2 postpartum |
|
|
|
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| Primary | Pumped Milk Volume Day 3 | Volume of milk pumped on day 3 postpartum | Posted | Least Squares Mean | Standard Deviation | mL | Day 3 postpartum |
|
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| Primary | Pumped Milk Volume Day 4 | Volume of pumped milk on Day 4 postpartum | Posted | Least Squares Mean | Standard Deviation | mL | Day 4 postpartum |
|
|
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| Primary | Pumped Milk Volume on Day 5 | Volume of pumped milk on Day 5 postpartum | Posted | Least Squares Mean | Standard Deviation | mL | Day 5 postpartum |
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| Primary | Pumped Milk Volume Day 6 | Volume of pumped milk on Day 6 postpartum | Posted | Least Squares Mean | Standard Deviation | mL | Day 6 postpartum |
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| Primary | Pumped Milk Volume on Day 7 | Volume of milk pumped on day 7 postpartum | Posted | Least Squares Mean | Standard Deviation | mL | Day 7 postpartum |
|
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|
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| Primary | Pumped Milk Volume at Day 14 | Volume of pumped milk on day 14 postpartum | Posted | Least Squares Mean | Standard Deviation | mL | Day 14 postpartum |
|
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| Primary | Pumped Milk Volume Day 21 | Volume of milk pumped on day 21 postpartum | Posted | Least Squares Mean | Standard Deviation | mL | Day 21 postpartum |
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| Primary | Pumped Milk Volume Day 28 | Volume of milk pumped on day 28 postpartum | Posted | Least Squares Mean | Standard Deviation | mL | Day 28 postpartum |
|
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| Primary | Pumped Milk Volume on Day 35 | Volume of milk pumped on day 35 postpartum | Posted | Least Squares Mean | Standard Deviation | mL | Day 35 postpartum |
|
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|
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| Primary | Pumped Milk Volume on Day 42 | Volume of milk pumped on day 42 postpartum | Posted | Least Squares Mean | Standard Deviation | mL | Day 42 postpartum |
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|
|
| 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 | Posted | Mean | Standard Deviation | hours from birth | Hours from birth to onset of lactogenesis stage 2 |
|
|
|
|
| Secondary | Days Lactated | Days mothers lactated until infant NICU discharge | Posted | Mean | Standard Deviation | days | birth to approximately 3 months |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | percent | Day 1 to 7 |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | percent | Day 7-14 |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | percent | Day 14-21 |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | percent | Day 21-28 |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | percent | Day 28-35 |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | percent | Day 35-42 |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | Percent | 24 hour period prior to NICU discharge |
|
|
|
|
| 0 |
| 52 |
| 0 |
| 52 |
| 0 |
| 52 |
| EG001 | Intermediate Expression | Initiation of milk expression 1-<3 hours following delivery. Intermediate expression: Initiation of milk expression 1-<3 hours following delivery. | 0 | 61 | 0 | 61 | 0 | 61 |
| EG002 | Late Initiation | Initiation of milk expression >3-6 hours following delivery. Late initiation: Initiation of milk expression >3-6 hours following delivery. | 0 | 55 | 0 | 55 | 0 | 55 |
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| D007744 |
| Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |