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Does protocol miconazole administration improve mortality and morbidity on surgical necrotizing enterocolitis?
Koshiro Sugita1, Mitsuru Muto1, Masakazu Murakami1
1Department of Pediatric Surgery, Research Field in Medical and Health Sciences, Medical and Dental Area, Research and Education Assembly, Kagoshima University, 8-35-1, Sakuragaoka, Kagoshima, 890-8520, Japan.
Purpose:
Our previous clinical pilot study reported that miconazole (MCZ) prevented morbidity from surgical necrotizing enterocolitis (NEC). The present study re-investigated this effect in a long-term cohort over 20 years.
Methods:
We conducted a retrospective cohort study from April 1998 to March 2020. A total of 1169 extremely low-birth-weight infants (ELBWIs) admitted to our neonatal intensive care unit, including 45 with NEC (3.8%), underwent surgery. Since 2002, protocol MCZ administration for 3 weeks has been applied for neonates born before 26 weeks' gestation or weighing under 1000 g. We compared the background characteristics and clinical outcomes between patients with and without MCZ administration.
Results:
The morbidity rate decreased after applying the MCZ protocol, but no improvement in mortality was seen. A propensity score-matched analysis indicated that treated patients by MCZ showed a delay in developing surgical NEC by 12 days. The MCZ protocol also helped increase body weight at surgery. Prophylactic MCZ administration did not improve the neurological development of the language-social and postural-motor domains in the surgical NEC patients. But cognitive-adaptive domain caught up by a chronological age of 3 years old.
Conclusions:
Revising the protocol to extend the dosing period may improve the outcomes of surgical NEC after the onset.
Insights
Miconazole (MCZ) administration in extremely low-birth-weight infants (ELBWIs) reduced surgical necrotizing enterocolitis (NEC) morbidity and delayed onset by 12 days. While mortality was unchanged, cognitive development improved by age three.
Area of Science:
- Neonatal Medicine
- Pediatric Surgery
- Pharmacology
Background:
- Necrotizing enterocolitis (NEC) is a significant cause of morbidity and mortality in extremely low-birth-weight infants (ELBWIs).
- Previous pilot studies suggested miconazole (MCZ) may prevent NEC morbidity.
- A long-term investigation was needed to re-evaluate MCZ's efficacy over two decades.
Purpose of the Study:
- To investigate the long-term effects of prophylactic miconazole (MCZ) administration on surgical necrotizing enterocolitis (NEC) in extremely low-birth-weight infants (ELBWIs).
- To compare clinical outcomes between ELBWIs who received MCZ and those who did not.
Main Methods:
- A retrospective cohort study analyzed 1169 ELBWIs admitted between April 1998 and March 2020.
- The study compared outcomes for infants with and without MCZ administration, with MCZ protocol initiated in 2002 for high-risk neonates.
- Propensity score-matched analysis was used to control for confounding factors.
Main Results:
- The MCZ protocol was associated with decreased NEC morbidity but did not improve mortality rates.
- MCZ-treated infants experienced a 12-day delay in the onset of surgical NEC and showed increased body weight at surgery.
- Neurological development in language-social and postural-motor domains was not improved, but cognitive-adaptive skills improved by age three.
Conclusions:
- Extending the miconazole (MCZ) dosing period may offer further improvements in outcomes for surgical necrotizing enterocolitis (NEC).
- Prophylactic MCZ demonstrates potential in managing NEC morbidity in ELBWIs, warranting further protocol optimization.
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