Caffeine Citrate in Preterm Infants at Risk of Apnea in Zambia

NCT06518603 | Not Yet Recruiting Phase 4 DMC

• 3 other identifiers: UAB-300013205UAB Dixon End Chair/3102800000533428-0004
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.Will the continued use of caffeine citrate lead to improved developmental outcomes among infants at 12 months of age?
3. 3.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
4. 4.Keep a diary of symptoms and any apneic events
5. 5.Check in with researchers via telephone call once a week
6. 6.Return to clinic for infant physical examination at 28 days
7. 7.Return to the clinic for infant physical examination at 2 months

Conditions

Premature Infant Disease; Apnea of Prematurity; Development, Infant

Outcome Measures

Primary Outcomes (2)

• Number of apneic events

  Documentation or report of apnea of prematurity \[AoP\], a condition exhibited by cessation of breathing for ≥20 or \<20 seconds accompanied by bradycardia and/or cyanosis

  28 days after discharge

• Number of visits to healthcare professionals related to apneic events

  Documentation or report of sick visit

  28 days after discharge

Secondary Outcomes (3)

• Number of all-cause sick visits

  2 months after discharge

• Percentage of neonatal mortality within 2 months after discharge

  2 months after discharge

• Infant/Child Developmental Assessment

  12 months

Study Arms (2)

Oral Caffeine Citrate 20mg/kg/day

EXPERIMENTAL

Caffeine Citrate 20 mg/kg/day given orally once a day for 28 days. (2mg/ml)

Drug: Caffeine citrate 20mg/kg/day

Placebo

PLACEBO COMPARATOR

Sterile water 1ml/kg/day given orally once a day for 28 days.

Drug: Placebo-Sterile water 1ml/kg/day

Interventions

Caffeine citrate 20mg/kg/day DRUG

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

Oral Caffeine Citrate 20mg/kg/day

Placebo-Sterile water 1ml/kg/day DRUG

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

Placebo

Eligibility Criteria

• Age: 0 Days - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Newborns:
• /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,
• On methylxanthines with plans to discontinue on methylxanthine,
• Off oxygen therapy for \>48 hours at the time of evaluation for eligibility,
• Receiving full daily feeds,
• Deemed stable and ready to go off caffeine as recommended by the Neonatologist
• + years of age (parent)

You may not qualify if:

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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• University Teaching Hospital, Lusaka, Zambia: collaborator
• Centre for Infectious Disease Research in Zambia: collaborator

Study Sites (1)

University Teaching Hospital

Lusaka, Lusaka Province, 10100, Zambia

Location

MeSH Terms

Conditions

Apnea

Interventions

caffeine citrate

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Albert Manasyan, MD

CONTACT

+260 976 448 994; Albert.Manasyan@cidrz.org

Waldemar A Carlo, MD

CONTACT

2059344680; wacarlo@uabmc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Masking will be maintained throughout the study and only the study pharmacists will be aware of the treatment group. The study pharmacist will prepare the 28-day supply of either caffeine citrate or placebo in indistinguishable clear solutions and same vials of equivalent volumes for the infant to continue at home. All other study staff, facility staff, follow-up staff, and family members will be masked to the treatment allocation. Identical vials will be prepared for the placebo arm with only a specific code written on the vials differentiating it from caffeine citrate. This code will be known only to the study pharmacist. Caffeine levels will not be checked routinely and checking levels will be discouraged to optimize masking.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Double blind, placebo-controlled, 1:1 parallel allocation

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: July 24, 2024
• Study Start: April 1, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: January 13, 2026

Record last verified: 2026-01

Locations

ZA (1)