Glycerin suppositories used prophylactically in premature infants (supp): A pilot randomized controlled trial

Abstract

BACKGROUND: Glycerin suppositories are often used to facilitate meconium evacuation in premature infants. The evidence for this practice is inconclusive. The purpose of this study was to assess the feasibility of a multicenter randomized controlled trial on the effectiveness of this treatment strategy. STUDY DESIGN: We conducted an external pilot study for a multicenter randomized controlled trial of premature infants randomized to glycerin suppositories or placebo procedure. Participants were included if they were gestational age of 24 weeks 0 days to 31 weeks 6 days and/or birthweight of 500 to 1500 grams. We excluded infants with life-threatening congenital anomalies, contraindications to receiving suppositories, or signs of clinical instability. Outcomes included cost, recruitment, and treatment-related adverse events. RESULT: A total of 109 were screened, 79 were initially eligible, and 34 consented to participate. Four of these infants were excluded prior to randomization due to thrombocytopenia, 30 were randomized, and 26 reached full enteral feeds. Three infants (10%) experienced rectal bleeding 5 to 43 days after completing study treatments. An anal fissure was noted in two of these patients. There were no cases of rectal perforation but one infant assigned to active treatment developed necrotizing enterocolitis. CONCLUSIONS: Conducting a multicenter randomized controlled trial on the use of glycerin suppositories in premature infants is feasible. Minor modifications to the study protocol are needed to increase participant recruitment and simplify the administration of study treatments.

The efficacy of glycerin suppositories for preterm infants: A meta-analysis of randomized controlled studies

“…[27][28][29][30] Glycerin suppositories might have the potential in reducing the time to reach full feeds. [16] One recent meta-analysis in 2015 assessed the use of glycerin enemas and suppositories in premature infants, and only included 3 single-center, randomized controlled trials involving 185 participants. [11] The results demonstrated the trend towards increased risk of necrotizing enterocolitis, but the quality of evidence was low to very-low for the outcomes, and the results were inconclusive.…”

“…[27–30] Glycerin suppositories might have the potential in reducing the time to reach full feeds. [16]…”

“…Two hundred forty-eight potentially relevant articles were identified initially and 5 RCTs were finally included in the meta-analysis. [14][15][16][17][18] The baseline characteristics of 5 included RCTs were shown in Table 1. These studies were published between 2011 and 2020, and the total sample size was 266.…”

“…Among the eligible RCTs, 4 trials reported days to full enteral feeds, [14][15][16][17] 2 trials reported the days under phototherapy, [17,18] while 2 trials reported necrotizing enterocolitis and death. [15,16] Jadad scores of the 5 included studies varied from 3 to 5, and all 5 studies had high-quality based on the quality assessment.…”

“…Several trials reported the full enteral feeds and serum bilirubin after treatment with glycerin suppositories in preterm infants, but the results were not well established. [14,[16][17][18] This systematic review and meta-analysis of RCTs aimed to assess the impact of glycerin suppositories on enteral feeds in preterm infants.…”