Health Trials

Caffeine Citrate in Preterm Infants at Risk of Apnea in Zambia

ConditionsPremature Infant DiseaseApnea of PrematurityDevelopment, Infant
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age0-12
SponsorUniversity of Alabama at Birmingham

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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,

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,

Disqualifiers

Newborns with neuromuscular conditions affecting respiration,

Major congenital malformations and genetic disorders,

Unable to obtain parental or guardian consent

Trial design

Design model

Parallel

Treatments tested in this trial

  • Caffeine citrate 20mg/kg/day

    Drug

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

  • Placebo-Sterile water 1ml/kg/day

    Drug

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

Treatment groups

340 Participants
are divided into 2 treatment groups
Group A: Oral Caffeine Citrate 20mg/kg/dayExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
28 days after discharge
2

Number of visits to healthcare professionals related to apneic events

Documentation or report of sick visit

Time frame
28 days after discharge

Secondary outcomes

1

Number of all-cause sick visits

Documentation or report of sick visit

Time frame
2 months after discharge
2

Percentage of neonatal mortality within 2 months after discharge

Documentation of neonatal death

Time frame
2 months after discharge
3

Infant/Child Developmental Assessment

Score on "Ages and Stages Questionnaire" obtained at clinic visit

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alabama at Birmingham

Lead sponsor

University Teaching Hospital, Lusaka, Zambia

Collaborator

Centre for Infectious Disease Research in Zambia

Collaborator

Source ClinicalTrials.gov
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