Background Meconium obstruction of prematurity (MOP) is the third most common cause of neonatal intestinal obstruction, especially in preterm infants. Delayed diagnosis and treatment of the condition can affect morbidity, mortality, hospital stay and the treatment cost of affected preterm infants. MOP can also lead to sub-acute/acute intestinal obstruction necessitating the use of contrast enema and laparotomy, both of which increase the risks of necrotizing enterocolitis (NEC) and intestinal perforation. The need for surgical intervention and anaesthesia has a potential negative impact on the infant’s future neurodevelopment.

Objectives Our pilot trial demonstrated that twice-daily saline enema is a feasible intervention to reduce time to reach full enteral feeds in very low birth weight (VLBW) infants. This study aims to explore the efficacy of saline enema in the treatment of MOP with respect to feasibility and safety by secondary analysis of data from the primary study which was a prospective open-label randomized controlled trial. We hypothesized that twice daily saline enema is an effective, feasible and safe intervention to treat MOP in VLBW infants as compared to glycerin suppositories (control).

Methods In this prospective open-label, pilot, randomized controlled trial, 61 infants who failed to pass meconium within 48 hours of birth were randomized to receive either twice-daily normal saline enema (SE) or a GS until they reached full enteral feeds (110 mL/kg/day). 28 were randomized to receive twice daily saline enemas (intervention) and 33 were controls who were treated conventionally with a glycerin suppositories as a control (GS, 2,000 mg, a quarter unit, 4 doses 12h apart). A standardized feeding protocol and departmental guidelines for other aspects of neonatal intensive care were used in all subjects. The primary outcomes was treatment failure, defined as the need for an additional intervention. Adverse events (AE) such as colonic perforation and NEC were also recorded. We performed both Intention to Treat (ITT) and Per Protocol (PP) analyses. Data on efficacy, safety, process and resource feasibility outcomes were monitored.

Results Sixty-one infants were randomized, with 28 infants managed with RWs and 33 with glycerin suppositories. There was no treatment failure in the SE arm. Two infants were referred to surgeons, one with difficulty in passing the catheter and the other for blood-stained meconium. However, both infants were subsequently successfully managed with saline enema administered by pediatric surgeons. Two infants met the criteria for treatment failure in the GS arm. One infant was managed with contrast enema and the other was managed with SE administered by surgeons. Results from the ITT analysis did not differ substantially from the PP analysis.

Conclusions Analysis of outcomes of our study suggest that nurse administered twice daily saline enema is an efficacious, safe and cost-effective strategy for meconium obstruction of prematurity as compared to glycerin suppositories. Study design of future trials may be refined, to address the limitations of this study such as larger sample size, inclusion of infants with birth weight less than 750 grams, infants with atypical presentation and refinement of treatment failure criteria.