跳至主要内容
临床试验/NCT04006509
NCT04006509已完成不适用

Prenatal Breast Pumping Education of Mothers and Their Support Person

University of Florida2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2018年11月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
2
主要终点
Onset of Lactogenesis Stage II Through Volume Attainment

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • English speaking
  • stated intent to breastfeed
  • anticipating the birth of a premature infant < 35 weeks gestation.

排除标准

  • known illicit maternal drug use
  • history of breast reduction or augmentation
  • positive HIV status
  • infant not expected to live over 2 weeks following delivery.

结局指标

主要结局

Onset of Lactogenesis Stage II Through Volume Attainment

时间窗: Up to 96 Hours

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

次要结局

  • Breast Milk Production on Day 1(0-24 hours postpartum)
  • Milk Production Day 3(3 days postpartum)
  • Breast Milk Production Day 4(Day 4 postpartum)
  • Breast Milk Production Day 14(Day 14 postpartum)
  • Breast Milk Production Day 21(21 days postpartum)
  • Time to Breast Pumping Initiation(first 24 hours after delivery)
  • Breast Milk Production Day 6(Day 6 postpartum)
  • Breast Milk Production Day 2(Day 2 postpartum)
  • Breast Milk Production on Day 5(Day 5 postpartum)
  • Breast Milk Production Day 7(Day 7 postpartum)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验