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

NCT06972108 | Not Yet Recruiting Phase 2

• 1 other identifier: Pro00140244
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• 24 hours oxygenation- 48-72 hours

  24 hours oxygenation (SpO2) at 48-72 hours before the administration of caffeine or placebo

  48-72 hours before the administration of caffeine or placebo

• 24 hours oxygenation - 72 hours

  24 hours oxygenation (SpO2) at 72 hours after the administration of caffeine or placebo

  72 hours after the administration of caffeine or placebo

Secondary Outcomes (2)

• Baseline point-of-care lung ultrasound (POCUS)

  At baseline

• Post randomization Point-of-care lung ultrasound (POCUS)

  60-84 hours after the administration of caffeine or placebo

Other Outcomes (3)

• Hospital Stay

  Up to 10 weeks

• Duration of respiratory support

  Up to 10 weeks

• Duration of oxygen therapy

  Up to 10 weeks

Study Arms (2)

Caffeine arm

EXPERIMENTAL

Caffeine at standard doses

Drug: Caffeine citrate

Placebo arm

PLACEBO COMPARATOR

Other: Saline (NaCl 0,9 %) (placebo)

Interventions

Caffeine citrate DRUG

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

Caffeine arm

Saline (NaCl 0,9 %) (placebo) OTHER

Saline PO for loading and daily maintenance

Placebo arm

Eligibility Criteria

• Age: 10 Days - 14 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants born through meconium-stained amniotic fluid, and
• Gestational age at or greater than 35+0 weeks at birth, and
• Postnatal age of 10 to 14 days-old, and
• Full enteral feeds either at semi-demand with a mix of gavage or oral feeds or at full-demand feeds by oral method, and
• 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
• High flow nasal cannula of less than or equal to 2L/min/Kg and FiO2 \<0.25, or
• Low flow nasal cannula at \<100 ml/min

You may not qualify if:

• Preterm infants of less than 35+0 weeks gestation, or
• Postnatal age younger than 9 day-old or older than 15 day-old, or
• Parenteral nutrition supplementation or full enteral feeds by gavage, or
• Received caffeine within 5 days prior to enrolment, or
• Currently, receiving invasive respiratory support or continuous positive airway pressure (CPAP), or
• 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
• 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
• Congenital anomalies including but not limited to respiratory tract malformations, congenital heart diseases, and syndromal abnormalities.

Sponsors & Collaborators

• University of Alberta: lead

Related Publications (1)

• 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.

  PMID: 38576961 BACKGROUND

MeSH Terms

Conditions

Meconium Aspiration Syndrome

Interventions

caffeine citrate; Sodium Chloride

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Po-Yin Cheung

CONTACT

1-780-716-2818; poyin@ualberta.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2025
• First Posted: May 14, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Twelve months after the completion of the study
• Access Criteria: The data may be obtained by direct application through the principal investigator of the study. Purpose of the use must be stated.