Medical device with simethicone and silicon dioxide to reduce inconsolable crying in newborns
Inconsolable crying in newborns not only causes concern among parents, but can also lead to serious consequences, such as increased risk of postpartum depression in mothers and early interruption of breastfeeding. In many cases, mothers suspect breast milk may be the source of discomfort and decide to stop nursing.
Infant colic is characterized by intense, unexplained, and persistent crying episodes in otherwise healthy infants, typically within the first few months of life. It is a major source of stress for families. Diagnosis is based on clinical criteria, particularly the Rome IV Criteria, which are used to classify functional gastrointestinal disorders in both children and adults.
According to the Rome IV Criteria, infant colic is defined by:
- Infant’s age: between 2 weeks and 4 months old.
- Crying and irritability: excessive and not linked to hunger, pain, or illness.
- Duration of crying: at least 3 hours/day, 3 days/week, for at least 1 week.
This is commonly referred to as the “Rule of 3”.
Despite its prevalence, no definitive treatment for infant colic has been established. Parents often turn to a range of remedies hoping to ease their child’s discomfort.
Among these, simethicone-based products are frequently used to relieve colic symptoms by helping gas bubbles coalesce in the stomach and intestines. However, the scientific evidence supporting simethicone’s effectiveness is still limited and conflicting.
Our goal was to evaluate the clinical effectiveness of a medical device combining simethicone and silicon dioxide (Rilefast Ace) in reducing symptoms of infant colic.
Study Design
We conducted a retrospective multicenter evaluation of medical records from 63 infants, aged 2 to 6 weeks, who were treated for 14 days with the oral formulation (Rilefast ACE drops, PJPHARMA) containing simethicone and silicon dioxide.
Pain was assessed using the Neonatal Infant Pain Scale (NIPS) after breastfeeding, before and after treatment. NIPS is a validated multidimensional scale used in both preterm and full-term infants. It evaluates facial expression, crying, breathing, limb movements, and arousal state. Final scores range from 0 to 7, with 7 indicating the highest pain level. (Spence K et al., 2005)
Study Results
NIPS scores after feeding were significantly lower following the 14-day treatment (5.03 ± 1.36 vs. 1.22 ± 1.45, p<0.001). A positive correlation was observed between the absolute NIPS reduction and:
- Pre-treatment NIPS (beta = 0.88, p = 0.001)
- Birth weight (beta = 2.39, p = 0.009)
- Baseline weight (beta = 1.58, p = 0.026)
A negative correlation was observed between formula feeding and symptom improvement (beta = -2.04, p = 0.015).
In conclusion, our findings suggest that the simethicone and silicon dioxide-based formulation in the Class IIb MDR-certified medical device Rilefast ACE may significantly improve infant colic symptoms. Pain duration and crying episodes were notably reduced, especially in newborns with more severe baseline distress.
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