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

NCT ID: NCT06972108

Last Updated: 2026-02-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-04-01
• Study Completion Date: 2028-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Caffeine arm

Caffeine at standard doses

Group Type: EXPERIMENTAL

Caffeine citrate

Intervention Type: DRUG

Caffeine citrate loading at 10 mg/kg, followed by daily maintenance of 5 mg/kg PO

Placebo arm

Group Type: PLACEBO_COMPARATOR

Saline (NaCl 0,9 %) (placebo)

Intervention Type: OTHER

Saline PO for loading and daily maintenance

Interventions

Caffeine citrate

Caffeine citrate loading at 10 mg/kg, followed by daily maintenance of 5 mg/kg PO

Intervention Type: DRUG

Saline (NaCl 0,9 %) (placebo)

Saline PO for loading and daily maintenance

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Infants born through meconium-stained amniotic fluid, and

2. Gestational age at or greater than 35+0 weeks at birth, and

3. Postnatal age of 10 to 14 days-old, and

4. Full enteral feeds either at semi-demand with a mix of gavage or oral feeds or at full-demand feeds by oral method, and

5. Stable respiratory condition for 24-48 hours prior to enrolment, and require respiratory support defined as: receiving non-invasive respiratory support including one of the following

1. High flow nasal cannula of less than or equal to 2L/min/Kg and FiO2 <0.25, or

2. Low flow nasal cannula at <100 ml/min

Exclusion Criteria

1. Preterm infants of less than 35+0 weeks gestation, or

2. Postnatal age younger than 9 day-old or older than 15 day-old, or

3. Parenteral nutrition supplementation or full enteral feeds by gavage, or

4. Received caffeine within 5 days prior to enrolment, or

5. Currently, receiving invasive respiratory support or continuous positive airway pressure (CPAP), or

6. During the study period with the administration of study medication, the infant cannot receive steroids including dexamethasone, hydrocortisone and budesonide by intravenous, enteral or inhalational route, or

7. Medical diseases including infections, electrolytes or acid-base imbalances, significant anemia, systematic and metabolic disorders that contribute to respiratory insufficiency other than meconium aspiration syndrome, or

8. Congenital anomalies including but not limited to respiratory tract malformations, congenital heart diseases, and syndromal abnormalities.

• Minimum Eligible Age: 10 Days
• Maximum Eligible Age: 14 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alberta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Po-Yin Cheung

Role: CONTACT

poyin@ualberta.ca

1-780-716-2818

References

Dini G, Ceccarelli S, Celi F, Semeraro CM, Gorello P, Verrotti A. Meconium aspiration syndrome: from pathophysiology to treatment. Ann Med Surg (Lond). 2024 Feb 15;86(4):2023-2031. doi: 10.1097/MS9.0000000000001835. eCollection 2024 Apr.

Reference Type: BACKGROUND

PMID: 38576961 (View on PubMed)

Other Identifiers

Pro00140244

Identifier Type: -

Identifier Source: org_study_id