NCT06972108

CAffeine Use in Prolonged Oxygen Use in meConium aspIration Syndrome in Neonatal Outcomes (CAPUCINO)

Caffeine for Oxygen Dependent Meconium Aspiration Syndrome

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of Alberta · Academic / Other
• Sex: All
• Age: 10 Days – 14 Days
• Healthy volunteers: Not accepted

Summary

When babies are stressed in the womb, they sometimes pass meconium in the amniotic fluid. When this happens, they may swallow the meconium-stained fluid into their lungs which may cause them to have poor oxygen levels and require resuscitation and significant breathing support in the early hours after birth. This is referred to as Meconium Aspiration Syndrome (MAS). Some babies may recover slowly and require breathing and/or oxygen support for days. Caffeine is a drug that can help improve breathing efforts and is commonly used in premature babies who do not have regular or strong breathing efforts. Caffeine has been used in babies with MAS who recovered slowly (i.e. requiring breathing or oxygen support for a longer period) for several years now. Despite having success in many babies, there is no evidence to examine its effectiveness and mechanism of action. This pilot study proposes to look at the effects of caffeine in babies with MAS who require ongoing breathing and oxygen support. There will also be examination of whether caffeine improves breathing efforts with better lung opening using ultrasound images of the lungs.

Conditions

• Meconium Aspiration Syndrome

Interventions

Type	Name	Description
DRUG	Caffeine citrate	Caffeine citrate loading at 10 mg/kg, followed by daily maintenance of 5 mg/kg PO
OTHER	Saline (NaCl 0,9 %) (placebo)	Saline PO for loading and daily maintenance

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-08-31
• Completion: 2028-12-31
• First posted: 2025-05-14
• Last updated: 2026-02-05