Precision drug therapy in neonates [Short Oral Session]

Key Takeaways from the Pharmacology, Neurology & Neonatal Exposures Session

We have reached the end of an incredible day at CEPAS 2026! The final session delivered fascinating insights into pharmacology, the microbiome, and early neuroprotection. We were also thrilled to see one of our very own 99nicu team members take the stage!

Here is the breakdown of the core messages from the final session:

• Neonatal Opioid Safety Attitudes: Türkiye vs. the UK (Esra Ardahan Akgül)

  • A cross-sectional study of 64 healthcare professionals compared knowledge and practices regarding neonatal opioid use.

  • Common Ground: Both countries demonstrated high agreement on the importance of strict monitoring protocols, recognizing opioid-related adverse effects, and maintaining medication safety.

  • Key Differences: Significant discrepancies emerged regarding familiarity with validated neonatal pain assessment tools, knowledge of naloxone use, and perceived adequacy of education.

  • While safety perceptions are generally positive, there is a clear international need for standardized, evidence-based education—particularly concerning the consistent use of validated pain scales.

• Caffeine Exposure & TDM in Preterm Infants (Francesca Chessa)

  • Is routine Therapeutic Drug Monitoring (TDM) necessary for caffeine? The short answer is no.

  • Having a "therapeutic" serum level (>15 mg/L) does not guarantee therapeutic success. Treatment success was independently associated with gestational age, not serum caffeine levels or pharmacokinetic markers like AUC.

  • Universal TDM is not supported by the data. TDM should be strictly targeted—for instance, to rule out caffeine toxicity when a baby presents with unexplained tachycardia.

• Additional Caffeine Doses & Hypoxic Burden (Kelly Storm)

  • For infants experiencing recurrent apneas despite standard maintenance therapy, administering an additional dose of caffeine (typically 5 mg/kg) is highly effective.

  • In the three hours following an additional dose, the hypoxic burden decreased by 43% and the number of desaturations decreased by 21%.

  • Infants with a high baseline frequency of desaturations (the top quartile) experienced the most significant clinical benefit.

• The ALBINO Trial: Early Postnatal Allopurinol (Axel Franz)

  • Allopurinol targets the secondary energy failure and superoxide generation that occurs upon reperfusion in evolving HIE. To be effective, it must be administered within a very tight window: under 45 minutes after birth.

  • The ALBINO trial navigated immense logistical and ethical hurdles across 10 countries and 69 sites to enroll 526 infants, successfully treating 376 within that strict 45-minute window using deferred or two-stage consent.

  • Primary outcome data (death or neurocognitive impairment at 24 months) will be available next year.

• Restoring Gut Microbiota via Maternal FMT (Noora Carpén)

  • Cesarean sections delay the colonization of beneficial maternal bacteria (like Bacteroides) and favor hospital-associated pathobionts.

  • The Secfort study (a double-blind RCT) safely administered a highly controlled Maternal Fecal Microbiome Transfer (FMT)—mixing 0.1g of screened maternal feces with breast milk—to C-section infants.

  • The FMT successfully shifted the microbiome closer to a vaginal-birth profile (higher Bacteroides and E. coli) without increasing adverse infectious events, and even stimulated early immune responses (higher CXCL proteins).

• In Utero Stimulant Exposure (Dotan Shaniv)

  • A huge congratulations to our very own 99nicu team member, Dotan, for a fantastic presentation closing out the day! 👏

  • Analyzing a massive retrospective cohort of over 7,000 pregnancies, the study looked at maternal use of ADHD stimulants (primarily methylphenidate/Ritalin) during pregnancy.

  • Reassuring Safety Profile: There was no increased risk of preterm birth or major congenital malformations.

  • While there was a statistically significant signal for lower birth weight, the actual mean reduction was only ~23 grams—suggesting that the clinical impact on fetal growth is highly uncertain and likely negligible.

What a fantastic end to the scientific program today. Let’s bring these topics back to our own units:

1. Pain Assessment in Practice: The data comparing Türkiye and the UK highlighted significant gaps in the use of validated neonatal pain assessment tools. Which pain scale is standard in your unit, and do you feel your team receives adequate ongoing training to use it effectively when administering opioids?

2. The Caffeine Ceiling: Between Francesca's data showing TDM isn't the answer and Kelly's data showing extra doses work, how does your unit handle apnea of prematurity that doesn't respond to standard dosing? Are you routinely pushing additional 5 mg/kg boluses?

3. Microbiome & Maternal Interventions: Maternal fecal microbiome transfer for C-section infants is a fascinating, expanding frontier. What are your thoughts on the practical and ethical implementation of restoring neonatal gut flora this early in life?

Disclosure: This is an AI-assisted summary of the session, generated from a recording made by our team in attendance. We believe it is as accurate as our own notes would be, but please refer to the speakers’ original work before applying anything in clinical practice.