World Health Day Spotlight: Pioneering Pediatric Research for a Healthier Start and Advancing Pediatric Health Through Clinical Trials on Infantile Colic in Newborns
Every year on April 7th, World Health Day draws global attention to pressing health issues and celebrates milestones in healthcare and honor global efforts to improve healthcare access and outcomes.
This year, we shine a light on a crucial yet often overlooked area of medical research: clinical trials involving healthy preterm and full-term newborns, with a special focus on infantile colic, a common but challenging condition for many families.
Understanding Infantile Colic
Infantile colic affects up to 40 % of newborns, it is characterized by episodes of excessive crying in an otherwise healthy baby. It typically begins within the first few weeks of life and is resolved by three to four months of age. While colic is not life-threatening, it can cause significant distress for both parents and caregivers. Despite its prevalence, the causes of colic remain poorly understood, and effective treatments are limited.
Why Pediatric Clinical Trials Matter
The pediatric population, especially newborns, has long been underrepresented in clinical research. Historically, most drugs and treatments have been tested primarily on adults, with little data to guide pediatric use. However, infants, particularly those born preterm, have unique physiological needs and vulnerabilities that must be considered when developing therapies.
Clinical trials that include newborns are essential for:
- Improving safety and efficacy of treatments specifically designed for infants
- Identifying early interventions that can prevent complications associated with pre-term birth or common newborn conditions like colic
- Guiding pediatricians and parents toward evidence-based care
Parents’ cooperation plays a vital role in this process by participating in research and helping to build the evidence base needed for future generations.
1Med recent clinical study: A Focus on Colic
This study managed by 1med involved Healthy infants of both genders, aged ≤ 12 weeks diagnosed with Infant colic, the primary objective was to evaluate the efficacy of Lactobacillus casei in reducing infantile colic.
Ensuring the highest standards of ethical conduct and parental involvement, the study was conducted in collaboration with pediatric clinics in Italy and Romania
The study has shown promising results, particularly in terms of safety and tolerability of a Lactobacillus casei strains which may help regulate gut flora and reduce crying episodes. However, more data is needed to confirm their effective benefits and optimal dosing.
To conclude ….
On this World Health Day, let’s recognize the importance of including our youngest patients in clinical research. By supporting well-designed pediatric trials, we move closer to ensuring that every child, regardless of gestational age, is given the healthiest possible start in life.