Pumping to Up Maternal Milk Production for Preterms (PUMMPP)
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Breastfeeding
- 发起方
- University of Alabama at Birmingham
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Volume of expressed breastmilk
- 状态
- 招募中
- 最后更新
- 上个月
概览
简要总结
The goal of this clinical trial is to learn about the effect of breast-pumping frequency on breast milk supply/ volume in mothers of preterm infants. The main question it aims to answer is:
- What effect does pumping frequency have on breast milk supply.
Researchers will compare breastmilk supply of mothers who pump every 2 hours to the supply of those who pump every 3 hours to see if there is a difference in the amount of breastmilk they produce.
Participants will be assigned to either pump every 2 hours or every 3 hours and record how many milliliters of breastmilk they produce daily for the first 28 days of their baby's life.
研究者
Colm Travers
Associate Professor
University of Alabama at Birmingham
入排标准
入选标准
- •Inborn infants \<32 weeks gestation
- •Out-born infants transferred to our facility \<48hours of life
- •Infants \<1500 grams at birth
- •Infants whose parents/ guardians have provided legal consent for study participation
排除标准
- •Infants with birthing persons' that are severe/critically ill
- •Birthing persons of infants \<18 years old
- •Infants with terminal illness or decision to withhold or limit support
- •infants with major congenital anomalies, chromosomal disorders, or congenital infections
结局指标
主要结局
Volume of expressed breastmilk
时间窗: From enrollment to 28 days of life
The primary outcome measure will be the volume of expressed breastmilk obtained in mL per day in the group pumping every 2 hours compared the group pumping every 3 hours
次要结局
- The percentage of donor breast milk feedings(From enrollment to 28 days of life)
- The time to full feedings(From enrollment to 28 days of life)
- The number of days alive on full feedings(From enrollment to 28 days of life)
- Average change in weight(from birth to 36 weeks' corrected gestational age)
- The number of infants with clinical evidence of feeding intolerance(From enrollment to first 28 days after birth)
- The number of infants exclusively feeding breastmilk at discharge(From enrollment to hospital discharge)
- Average change in length(from birth to 36 weeks corrected gestational age)
- Average change in head circumference(from birth to 36 weeks' corrected gestational age)
- Number of central line days(In the first 28 days of life)
- The number of infants receiving any volume of breastmilk at time of discharge(From enrollment to hospital discharge)
- The Bayley Scales of Infant and Toddler Development (BSID)(From 18-26 months of age)
- The Bayley Scales of Infant and Toddler Development (BSID)(from 18-26 months of age)