Affiliations: [a]
McMaster Pediatric Surgery Research Collaborative
| [b] Department of Pediatrics, McMaster University, Hamilton, ON, Canada
| [c] Division of Neonatology, McMaster University, Hamilton, ON, Canada
| [d] CanChild Center for Childhood Disability Research, McMaster University, Hamilton, ON, Canada
| [e] Division of Pediatric Surgery, McMaster University, Hamilton, ON, Canada
| [f] Division of Pediatric Surgery, Western University, London, ON, Canada
| [g] Division of Pediatric Surgery, University of Rochester, Rochester, NY, USA
Correspondence:
[*]
Address for correspondence: J. Mark Walton, McMaster Children’s Hospital, 1200 Main Street West, Room 4E3, Hamilton, Ontario, Canada, L8 N 3Z5. Tel.: +1 905 521 2100 / Ext. 75244; E-mail: waltonj@mcmaster.ca.
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.
