SUpporting Mothers Milk Intervention Trial (SUMMIT)- A randomized controlled trial comparing different doses of domperidone for treating lactation insufficiency in mothers of preterm infants

South Australian Health and Medical Research Institute0 个研究点目标入组 170 人开始时间: 2021年4月30日最近更新: 2024年3月25日

试验速览

暂无简介。

•Mothers of preterm infants born <34 weeks' gestation (up to 33+6)
•-Lactation insufficiency defined as breast milk volume less than 300 mL/day in previous 24 hours if between 7 and 13 days postpartum, or breast milk volume less than 500 mL/day in previous 24 hours if between 14 and 28 days postpartum.
•-Between 7 and 28 days postpartum
•-Expressing with an electric pump an average of 6 times a day or more in previous 24-48 hours
•-Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessment and follow-up of mother and baby until infant discharge.
•-Signed and written consent.

•- Evidence of current Q-Tc prolongation (according to screening ECG)
•- Already taking domperidone
•- Allergy to domperidone
•- History of known or suspected cardiac dysrhythmias (tachyarrhythmia, Q-Tc prolongation) or currently on an anti-arrhythmic medication
•- Currently experiencing mastitis
•- Previous breast surgery, including augmentation or reduction, nipple piercing
•- Known chronic renal or hepatic impairment
•- Contraindication to breastfeeding (e.g., HIV)
•- Known to have a prolactin-releasing pituitary tumor
•- Currently taking medications known to alter the metabolism and pharmacokinetics of domperidone and cause Q-Tc prolongation (e.g., oral azole antifungals, erythromycin antibiotics)
•- Higher order pregnancies (triplet, or more)

发起方