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Completed

NCT Number: NCT04006509

Prenatal Breast Pump Education of Mothers and Their Support Person

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.

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Key information

Conditions

Preterm Birth Behavior Breast Feeding Feeding Behavior Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UF Health at the University of Florida

Gainesville, Florida, 32610, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Prenatally Delivered Lactation Educational Program

Behavioral

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

Other names: Antenatal Education

Primary outcomes

  1. Onset of Lactogenesis Stage II Through Volume Attainment

    Time frame: Up to 96 Hours

    Time in hours until mothers pump at least 20 mL of milk in 2 consecutive pumping sessions

Secondary outcomes

  1. Breast Milk Production on Day 1

    Time frame: 0-24 hours postpartum

    Volume of breast milk produced from 0-24 hours postpartum

  2. Time to Breast Pumping Initiation

    Time frame: first 24 hours after delivery

    Time to mothers beginning to pump breasts after delivery

  3. Breast Milk Production Day 2

    Time frame: Day 2 postpartum

    Volume of breast milk produced on day 2 postpartum

  4. Milk Production Day 3

    Time frame: 3 days postpartum

    Volume of milk produced on Day 3 postpartum

  5. Breast Milk Production Day 4

    Time frame: Day 4 postpartum

    Volume of breast milk produced on Day 4 postpartum

  6. Breast Milk Production on Day 5

    Time frame: Day 5 postpartum

    Volume of breast milk produced on Day 5 postpartum

  7. Breast Milk Production Day 6

    Time frame: Day 6 postpartum

    Volume of breast milk produced on Day 6 postpartum

  8. Breast Milk Production Day 7

    Time frame: Day 7 postpartum

    Volume of milk produced on Day 7 postpartum

  9. Breast Milk Production Day 14

    Time frame: Day 14 postpartum

    Volume of breast milk produced on Day 14 postpartum

  10. Breast Milk Production Day 21

    Time frame: 21 days postpartum

    Volume of breast milk produced on Day 21 postpartum

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

Prenatal Breast Pumping Education of Mothers and Their Support Person

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Jul 5, 2019
Registry last updated
May 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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