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Caffeine Citrate in Preterm Infants at Risk of Apnea in Zambia

NCT06518603 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 340

Last updated 2026-04-07

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if caffeine citrate prevents apneic events that result in sick visits in moderately preterm infants after discharge from the hospital. It will also learn if the use of caffeine leads to better developmental outcomes at 12 months of age.

Our research questions are:

1. Does continued treatment of moderately preterm newborns with caffeine citrate after hospital discharge prevent or decrease apneic events that result in sick visits?
2. Will the continued use of caffeine citrate lead to improved developmental outcomes among infants at 12 months of age?

Researchers will compare caffeine citrate to a placebo (a look-alike substance that contains no drug) to see if caffeine citrate prevents apneic spells which result in healthcare visits.

Parents of participants will:

1. Administer caffeine citrate 20mg/kg/day or a placebo (equivalent volume of sterile water) orally every day for up to 28 days after hospital discharge
2. Keep a diary of symptoms and any apneic events
3. Check in with researchers via telephone call once a week
4. Return to clinic for infant physical examination at 28 days
5. Return to the clinic for infant physical examination at 2 months

5\. Return to clinic for infant neurodevelopmental examination with Ages and Stages Questionnaire at 12 months of age

Conditions

  • Premature Infant Disease
  • Apnea of Prematurity
  • Development, Infant

Interventions

DRUG

Caffeine citrate 20mg/kg/day

Caffeine citrate 20mg/kg/day given orally once daily for 28 days

DRUG

Placebo-Sterile water 1ml/kg/day

Placebo-sterile water 1mg/kg/day given orally once daily for 28 days

Sponsors & Collaborators

  • University Teaching Hospital, Lusaka, Zambia

    collaborator OTHER

  • Centre for Infectious Disease Research in Zambia

    collaborator OTHER

  • University of Alabama at Birmingham

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
0 Days
Max Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2027-05-31
Completion
2027-06-30

Countries

  • Zambia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06518603 on ClinicalTrials.gov