Clinical effects of breast milk on enema-induced meconium evacuation in super premature infants and preterm infants: a randomized controlled trial

Shengjing Hospital of China Medical University0 个研究点目标入组 286 人开始时间: 2019年9月14日最近更新: 2024年5月13日

适应症

试验速览

2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33902678/ (added 28/04/2021) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38648060/ (added 29/04/2024)

•1. Super premature infants 23W = gestational age <28W and Preterm infants 28W = gestational age <30W
•2. Mother provides breast milk 48 hours after birth
•3. Normal intestinal motility (as assessed by the team of clinical experts)
•4. Parental agreement to participate in the study

•1. Congenital digestive tract abnormalities, such as congenital gastrointestinal dysfunction
•2. Congenital malformations, gastrointestinal malformations, such as rectal anal deformities
•3. Abnormal hemodynamics, such aspoor intestinal motility, diarrhea, intussusception, and necrotizing enterocolitis (NEC)
•4. Anorectal mucosal injury
•5. Surgery within 48 hours after birth
•6. Severe coagulopathy:
•6.1 International standardization ratio >1.4
•6.2 Partial thromboplastin time >39s
•6.3 Fibrinogen <1.00g/L
•6.4 Platelet count <100×109/L
•7. Sepsis, symptomatic patent ductus arteriosus (PDA)
•8. Neutropenia (absolute number of neutrophils <0.5×109/L)
•9. Blood incompatible hemolytic disease of the newborn, requiring immediate blood exchange
•10. Mother with severe disease or using medicine that is contraindicated during lactation
•11. Researchers to exclude anyone that they felt would not be a good trial participant

发起方

Shengjing Hospital of China Medical University