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Glycerin suppositories used prophylactically in premature infants (SUPP) trial: a study protocol for a pilot
Michael H Livingston1, Jorge Zequeira2, Henrietta Blinder3
1McMaster Pediatric Surgery Research Collaborative, McMaster Children's Hospital, Health Sciences Centre Room 4E3, 1280 Main Street West, Hamilton, Ontario L8S 4K1 Canada ; Clinician Investigator Program, Postgraduate Medical Education, McMaster University, MDCL Rm 3101, 1280 Main Street West, Hamilton, Ontario L8S 4K1 Canada.
Insights
This pilot study evaluates glycerin suppositories for premature infants to improve feeding tolerance in the NICU. Further trials are needed to confirm if this intervention reduces time to full enteral feeds.
Area of Science:
- Neonatalogy
- Clinical Trials
- Pediatric Gastroenterology
Background:
- Feeding difficulties are common in premature infants in the neonatal intensive care unit (NICU).
- Glycerin suppositories are used to promote meconium passage and prevent feeding intolerance, but evidence is limited.
- A pilot study is crucial to assess the feasibility of a larger trial.
Purpose of the Study:
- To assess the feasibility of a multicenter randomized controlled trial (RCT) for glycerin suppositories in premature infants.
- To determine the potential of glycerin suppositories to decrease the time to full enteral feeds.
- To evaluate the safety and cost-effectiveness of this intervention.
Main Methods:
- A placebo-controlled, parallel-design pilot RCT involving 30 premature infants (gestational age 24-32 weeks, birth weight 500-1500g).
- Infants received either 250mg glycerin suppositories or placebo daily until meconium evacuation or for up to 12 days.
- Outcomes included randomization rates, time to full enteral feeds, cost, and adverse events (e.g., rectal bleeding).
Main Results:
- This section is not available in the provided abstract.
- The pilot study's primary outcomes focus on feasibility metrics.
- Results will inform the design of a larger, powered multicenter trial.
Conclusions:
- This pilot study will establish the feasibility of conducting a larger RCT on glycerin suppositories for premature infants.
- The findings will guide a subsequent trial to definitively assess the efficacy of glycerin suppositories in improving feeding outcomes.
Background:
Feeding is a significant challenge for premature infants in the neonatal intensive care unit (NICU). These patients are often treated with glycerin suppositories to stimulate the passage of meconium and prevent feeding intolerance. Unfortunately, the evidence for this practice is inconclusive.
Methods/Design:
This protocol is for an external pilot study that will assess the feasibility of a superiority, placebo-controlled, parallel-design, multicenter randomized controlled trial. Participants are premature infants treated in a level 3 NICU with a gestational age 24 to 32 weeks and/or birth weight of 500 to 1500 g. Thirty participants will be recruited as part of this external pilot study. Participants will be randomized to glycerin suppository (250 mg) or placebo starting 48 to 72 h after birth and continuing once daily until meconium evacuation is complete or for a maximum of 12 days. The placebo consists of a 250-mg glycerin suppository placed in the diaper rather than the rectum. Study treatments are administered by the charge nurse on duty who is not otherwise involved in patient care. All other clinicians and research personnel will remain blinded. Outcomes for the pilot study are percentage of eligible participants randomized, percentage of infants reaching full enteral feeds, cost, and treatment-related adverse events (rectal bleeding, rectal perforation, and anal fissure).
Discussion:
This external pilot study will assess the feasibility of a multicenter randomized controlled trial of glycerin suppositories in premature infants. The subsequent multicenter trial will have sufficient power to determine whether this treatment strategy is associated with decreased time to full enteral feeds.
Trial Registration:
ClinicalTrials.gov: NCT02153606.
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