Prenatal Breast Pump Education of Mothers and Their Support Person

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.

• Prenatally Delivered Lactation Educational Program (Behavioral), also known as Antenatal Education: 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

Primary outcomes

• 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 outcomes

• Breast Milk Production on Day 1 [0-24 hours postpartum]: Volume of breast milk produced from 0-24 hours postpartum
• 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 5 [Day 5 postpartum]: Volume of breast milk produced on Day 5 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

Sex: All, ages: 18 Years to 70 Years, accepts healthy volunteers

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.

Participant flow

Outcome results

• Onset of Lactogenesis Stage II Through Volume Attainment (Primary), Mean, hours: Antenatal Education Group 84.8 (58.8 to 102.6); Standard of Care Group 81 (61.3 to 101.3) (p 0.985)
• Breast Milk Production on Day 1 (Secondary), Median, mL: Antenatal Education Group 15.3 +/- 16.5; Standard of Care Group 24.3 +/- 28.1 (p 0.539)
• Time to Breast Pumping Initiation (Secondary), Mean, Hours: Antenatal Education Group 4 +/- 3.5; Standard of Care Group 3.8 +/- 3.4 (p 0.959)
• Breast Milk Production Day 2 (Secondary), Mean, mL: Antenatal Education Group 32.7 +/- 35.6; Standard of Care Group 39.5 +/- 43.7 (p 0.743)
• Milk Production Day 3 (Secondary), Mean, mL: Antenatal Education Group 55.88 +/- 57.9; Standard of Care Group 59.7 +/- 58 (p 0.886)
• Breast Milk Production Day 4 (Secondary), Mean, mL: Antenatal Education Group 101.8 +/- 126.6; Standard of Care Group 97.4 +/- 87.2 (p 0.107)
• Breast Milk Production on Day 5 (Secondary), Mean, mL: Antenatal Education Group 149.9 +/- 167.4; Standard of Care Group 138.5 +/- 113.2 (p 0.687)
• Breast Milk Production Day 6 (Secondary), Mean, mL: Antenatal Education Group 245.3 +/- 317.9; Standard of Care Group 266.8 +/- 300.1 (p 0.871)
• Breast Milk Production Day 7 (Secondary), Mean, mL: Antenatal Education Group 345 +/- 558.4; Standard of Care Group 361.9 +/- 342.3 (p 0.376)
• Breast Milk Production Day 14 (Secondary), Mean, mL: Antenatal Education Group 431 +/- 416.7; Standard of Care Group 428 +/- 349.9 (p 0.770)
• Breast Milk Production Day 21 (Secondary), Mean, mL: Antenatal Education Group 725 +/- 1070.1; Standard of Care Group 573.9 +/- 402.1 (p 0.237)

Adverse events

Time frame: 21 days

• Results publication: 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. PMID 35475721

• Study Protocol and Statistical Analysis Plan (PDF, 2019-06-16)
• Informed Consent Form (PDF, 2011-10-19)

• Leslie A Parker, Principal investigator, University of Florida