NCT02545127终止2 期
A Randomized, Double-blind, Placebo-controlled, Multicenter Trial Exploring the Efficacy and Safety of Intra-nasal Administration of Merotocin in Increasing Milk Production in Maternal Subjects With Preterm Delivery and Inadequate Milk Production
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Volume of Mother's Own Milk (MoM)
研究概览
简要总结
Induction and support of lactation in women with preterm delivery and inadequate milk production.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Delivered at the hospital system associated with the trial center
- •Delivered preterm singleton gestational age 24 weeks + 0 days to 34 weeks + 2 days
- •Willing to express milk at least 5 times every 24 hours during the observation period and 6 to 8 times every 24 hours during the treatment and post-treatment follow up
- •Produced < 200 mL milk in 24 hours prior to randomization
- •Delivered 96 to 192 (+4) hours prior to randomization
排除标准
- •Pre-pregnancy body mass index (BMI) > 50 kg/m^2
- •History of breast trauma, breast surgery, nipple piercing
- •Prolactin-releasing pituitary tumor, history of Sheehan's syndrome, pituitary surgery/radiation therapy
- •Pre-pregnancy insulin-dependent diabetes mellitus, polycystic ovarian syndrome. Note: gestational diabetes is allowed (also when requiring the use of insulin for treatment)
- •Unstable thyroid disease
- •Moderate or severe renal or hepatic impairment
- •Mental illness
- •Significant nasal congestion or mucous production
- •Use of anti-psychotic drugs within past 12 months
研究组 & 干预措施
Merotocin (a selective oxytocin-receptor agonist)
Experimental
干预措施: Merotocin (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Volume of Mother's Own Milk (MoM)
时间窗: Daily days 1 to 14
Measured by weight in grams converted to volume in milliliters (mL)
次要结局
- Time to First Occurrence of Daily Volume of MoM ≥ 500 mL(From randomization (Day 1) to Day 14)
- Proportion of Maternal Participants With Markedly Abnormal Changes in Laboratory Values(From screening up to Day 15)
- Time to First Occurrence of Daily Volume of MoM ≥ 750 mL(From randomization (Day 1) to Day 14)
- Proportion of Participants With a Daily Volume of MoM ≥ 500 mL(Days 1 to 14)
- Proportion of Participants With a Daily Volume of MoM ≥ 750 mL(Days 1 to 14)
- Volume of MoM(Days 15 to 17)
- Volume of MoM Fed to the Infant(Days 1 to 14)
- Volume of Formula/Donor Milk Fed to the Infant(Days 1 to 14)
- Merotocin Concentration in Milk(Day 10)
- Change in Infant Body Weight(From baseline (Day 1) to Day 14)
- Frequency of Adverse Events (AEs) in Maternal Participants(From Screening (0-144 hours of delivery) up to Day 18)
- Intensity of AEs in Maternal Participants(From Screening (0-144 hours of delivery) up to Day 18)
- Frequency of AEs in Infants(From screening until milk expressed Days 1-14 is consumed/discarded or infant discharged from neonatal intensive care unit (NICU), whichever occurs last.)
- Intensity of AEs in Infants(From screening until milk expressed Days 1-14 is consumed/discarded or infant discharged from neonatal intensive care unit (NICU), whichever occurs last.)
- Changes in Routine Safety Laboratory Parameters in Maternal Participants(From screening up to Day 15)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Preterm Donor Human Milk Supplementation of Mother's Own Milk in VLBW InfantsPrematurityNCT05675397National and Kapodistrian University of Athens200
已完成
不适用
Breastfeeding Intervention StudyBreast FeedingNCT02016586Abbott Nutrition228
招募中
不适用
Targeted Fortification of Donor Breast Milk in Preterm InfantsFailure to Thrive in NewbornExtreme PrematurityGrowth FailureInfant Nutrition DisordersGrowth RetardationNCT04294368Columbia University50
已完成
不适用
Effects of the Breastfeeding Support for Late Preterm Infant mothers with Educational Program to Nurses: A Randomized Controlled TrialJPRN-UMIN000035227Yokohama City University76
已完成
不适用
Preterm milk Fortification in NeonatesPreterm gut inflammation and other outcomes of prematurity (growth, length of hospital stay)Neonatal DiseasesDisorders related to short gestation and low birth weightISRCTN22484792ewcastle upon Tyne Hospitals NHS Foundation Trust36