Glycerin Suppositories Used Prophylactically in Premature infants (SUPP): A pilot study for a multicentre randomized controlled trial
Bibliographic record
Abstract
BACKGROUND: Adequate feeding is a significant challenge for premature infants in the neonatal intensive care unit. 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 limited and inconclusive. METHODS: We conducted a systematic review on the use of glycerin suppositories and enemas in premature infants. Following this, we conducted a pilot study for a multicenter randomized controlled trial of premature infants randomized to glycerin suppositories or a placebo procedure once daily. Outcomes included rate of recruitment, rate of reaching the primary endpoint of full enteral feeds, treatment-related adverse events, and cost. RESULTS: Twenty-two infants were recruited and randomized active treatment or the placebo procedure. Gestational age was 24-32 weeks and birth weight was 500-1500 grams. During the study period, 61 infants were screened, 46 (75%) were eligible and approached for consent, 25 (54%) consented to participate, 22 (48%) were randomized, and 19 reached the primary endpoint of full enteral feeds. Three infants (14%) experienced rectal bleeding 5 to 43 days after completing study treatments. An anal fissure was also noted in two of these patients (9%). There were no cases of rectal perforation or necrotizing enterocolitis. Protocol violations occurred during 14 of 130 (11%) treatment days. The total cost for running this pilot study was estimated to be $16,000. A revised sample size calculation for the multicenter study indicated that 72 infants would be required to detect a treatment effect of 2 days faster to full enteral feeds. CONCLUSIONS: This external pilot study suggested that conducting a multicenter randomized controlled trial of glycerin suppositories in premature infants is feasible and safe. In the multicenter trial, we recommend tolerating a lower platelet count in the exclusion criteria, using a fixed rather than variable treatment duration, conducting follow-up assessments at predefined time points, and conducting an interim analysis to ensure that treatment is not associated with increased risk of necrotizing enterocolitis.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.012 | 0.014 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.006 | 0.006 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.003 | 0.002 |
| Insufficient payload (model declined to judge) | 0.006 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".