Caffeine citrate after discharge for moderately preterm infants at risk of apnea

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional, phase 4 trial randomizes eligible moderately preterm infants to receive caffeine citrate at 20 mg/kg/day or a matched placebo for 28 days after discharge. The study assesses whether continued caffeine reduces apneic events leading to sick visits and whether it supports better development at 12 months. Dosing is prepared and blinded, with caregivers recording apneic spells and adhering to the diary and dosing schedule. No routine caffeine level monitoring is conducted to maintain masking, and standard post-discharge care continues alongside the trial protocol. The trial is conducted in Lusaka, Zambia, with collaboration between University of Alabama at Birmingham and local partners.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Newborns:

1. 29 0/7 to 33 6/7 weeks GA (or with a birth weight 1.0 to 2.0 kg if pregnancy dating is unreliable) admitted to the UTH NICU,
2. On methylxanthines with plans to discontinue on methylxanthine,
3. Off oxygen therapy for \>48 hours at the time of evaluation for eligibility,
4. Receiving full daily feeds,
5. Deemed stable and ready to go off caffeine as recommended by the Neonatologist
6. 18+ years of age (parent)

Exclusion Criteria:

1. Newborns with neuromuscular conditions affecting respiration,
2. Major congenital malformations and genetic disorders,
3. Unable to obtain parental or guardian consent

Where it's running

• University Teaching Hospital
  Lusaka, Lusaka Province, Zambia Recruiting

Study contacts

• Study coordinator: Albert Manasyan, MD
• Email: Albert.Manasyan@cidrz.org
• Phone: +260 976 448 994

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.