Prenatal Breast Pump Education of Mothers and Their Support Person

Preterm Birth Clinical Trial

Official title:

Prenatal Breast Pumping Education of Mothers and Their Support Person

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04006509
• Other study ID #: P0081761
• Secondary ID: IRB201400318
• Status: Completed
• Phase: N/A
• Start date: November 6, 2018
• Est. completion date: May 4, 2022

Study information

• Verified date: May 2024
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: May 4, 2022
• Est. primary completion date: May 4, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Feeding
• Premature Birth
• Preterm Birth

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
United States	UF Health at the University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	Up to 96 Hours
Secondary	Breast Milk Production on Day 1	Volume of breast milk produced from 0-24 hours postpartum	0-24 hours postpartum
Secondary	Time to Breast Pumping Initiation	Time to mothers beginning to pump breasts after delivery	first 24 hours after delivery
Secondary	Breast Milk Production Day 2	Volume of breast milk produced on day 2 postpartum	Day 2 postpartum
Secondary	Milk Production Day 3	Volume of milk produced on Day 3 postpartum	3 days postpartum
Secondary	Breast Milk Production Day 4	Volume of breast milk produced on Day 4 postpartum	Day 4 postpartum
Secondary	Breast Milk Production on Day 5	Volume of breast milk produced on Day 5 postpartum	Day 5 postpartum
Secondary	Breast Milk Production Day 6	Volume of breast milk produced on Day 6 postpartum	Day 6 postpartum
Secondary	Breast Milk Production Day 7	Volume of milk produced on Day 7 postpartum	Day 7 postpartum
Secondary	Breast Milk Production Day 14	Volume of breast milk produced on Day 14 postpartum	Day 14 postpartum
Secondary	Breast Milk Production Day 21	Volume of breast milk produced on Day 21 postpartum	21 days postpartum