Pumping to Up Maternal Milk Production for Preterms (PUMMPP)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Volume of expressed breastmilk
研究概览
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
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
研究组 & 干预措施
Pumping every 2 hours
Mothers of patients in this group will be assigned to pump/ express breastmilk every 2 hours.
干预措施: Pumping every 2 hours (Behavioral)
Pumping every 3 hours
Mothers of patients in this group will be assigned to pump/ express breastmilk every 3 hours.
干预措施: breast pumping every 3 hours (Behavioral)
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)
研究者
Colm Travers
Associate Professor
University of Alabama at Birmingham