Abstract
BackgroundDelayed 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/designThe 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.DiscussionThe 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 registrationISRCTN Registry ISRCTN17847514. Registered on September 14, 2019
Highlights
Delayed meconium evacuation is an important cause of intestinal dysfunction in preterm infants
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
Feeding is a significant challenge for premature infants, and establishing full enteral feeding is an important goal in their care
Summary
Due to the large number of premature infants being born worldwide, countries are facing an enormous medical burden. If meconium evacuation can be expedited through the use of an effective enema, this may lead to a faster transition to full enteral feeding and a decreased reliance on intravenous nutrition. To the best of our knowledge, the major strength of this randomized controlled trial is to evaluate, for the first time, the effectiveness of a breast milk enema in promoting complete meconium evacuation and reach full enteral feeding among preterm and extremely preterm infants. The results will provide critical information regarding a new enema to effectively evacuate meconium in preterm infants. Some infants achieving complete meconium evacuation may withdraw before observing the time to reach full enteral feeding. We will further analyze and design a more comprehensive investigation based on this study This trial is a single-center clinical trial.
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