Clinical effects of breast milk enema on meconium evacuation in premature infants: study protocol for a randomized controlled trial

Abstract

Background Delayed meconium evacuation is an important cause of intestinal dysfunction in preterm infants. There are many methods to induce defecation in preterm infants: however, the effects are controversial. Finding a new intervention method to promote meconium evacuation in premature infants is necessary. Therefore, in the proposed study, the effectiveness of breast milk enema on complete meconium evacuation and time to achieve full enteral feeding will be investigated in preterm infants. Methods/design The study is a randomized, open-label, parallel-group, and single-center clinical trial. A total of 294 preterm infants will be recruited and stratified based on gestational age. Then, the infants will be assigned in a randomized block design to the intervention and control groups with a 1:1 ratio. Preterm infants in the control and intervention groups will receive saline enema and breast milk enema, respectively. The primary outcomes will be the time to achieve complete meconium evacuation from birth and time to achieve full enteral feeding from birth in preterm infants. The secondary outcomes will include hospitalization days, body weight at discharge, duration of total parenteral nutrition, cholestasis, and adverse events. Discussion The results of this trial will determine whether breast milk enema shortens the time to complete meconium evacuation and the time to achieve full enteral feeding in extremely preterm and preterm infants. Furthermore, the study results may provide a new, safe, inexpensive, and easy-to-use intervention to effectively evacuate meconium in preterm infants. Trial registration ISRCTN Registry ISRCTN17847514. Registered on September 14, 2019

Breast Milk Enema and Meconium Evacuation Among Preterm Infants

“…Neonates were excluded if they had congenital malformations, congenital gastrointestinal anomalies, anorectal deformities, diarrhea, intussusception, NEC, patent ductus arteriosus, sepsis, neutropenia, and coagulopathy. The trial protocol was approved by the medical ethics committee of Shengjing Hospital, China Medical University. All relevant ethical regulations were followed.…”

“…Criteria for termination of the intervention included complete meconium evacuation, discontinuation of the intervention for infants experiencing adverse events (AEs) deemed unsuitable to proceed, or withdrawal of the guardian’s consent. The feeding and parenteral nutrition procedures in the control and intervention groups are detailed in the protocol . Other than the different enemas, there were no differences in treatment strategies or nursing methods between the control and intervention groups.…”

“…The feeding and parenteral nutrition procedures in the control and intervention groups are detailed in the protocol. 24 Other than the different enemas, there were no differences in treatment strategies or nursing methods between the control and intervention groups. The Trial Steering Committee dynamically monitored the rate of loss to follow-up.…”