Antenatal Education to Increase Lactation Success

Preterm Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

• Verified date: November 2021
• Source: University of Florida
• Contact: Leslie A Parker
• Phone: 352 215 9360
• Email: parkela[@]ufl.edu
• 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: Recruiting
• Enrollment: 280
• Est. completion date: May 2022
• Est. primary completion date: May 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 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	Breast milk production	Daily volume of breast milk produced	three weeks
Secondary	Time to breast pumping initiation	Time to mothers beginning to pump breasts after delivery	first 24 hours after delivery