Antenatal Education to Increase Lactation Success

Study Overview
=================
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.

Official Title
-----------------
Antenatal Education of Mothers at Risk for Preterm Delivery and Their Support Person to Enhance Lactation Success

Conditions
-----------------
Preterm Birth, Breast Feeding

Intervention / Treatment
-----------------
* Behavioral: Prenatally Delivered Lactation Educational Program


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Antenatal Education Group<br>Patients will receive a prenatally delivered lactation educational program. | Behavioral: Prenatally Delivered Lactation Educational Program<br>* 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<br>* Other names: Antenatal Education;|
| No Intervention: Standard of Care Group<br>Patients will receive standard of care and not a prenatally delivered lactation educational program. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Onset of Lactogenesis Stage II through maternal report of a sudden breast fullness | Beginning 24 hours after delivery and continuing daily, mothers will be questioned regarding a sudden feeling of breast fullness as an indicator of onset lactogenesis II. Will confirm patient self-reporting by determining whether >100mL of milk is produced per a 24-hour period. | Up to 72 Hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breast milk production | Daily volume of breast milk produced | three weeks | 
| Time to breast pumping initiation | Time to mothers beginning to pump breasts after delivery | first 24 hours after delivery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
preterm breast milk