Clinical trial NCT06327152: Caffeine Use in the Management of Preterm Infants
Official title: Caffeine Use in the Management of Preterm Infants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Apnea of Prematurity
Keywords: Feeding
Caffeine
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2024-03-25
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 40
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized, double-blinded, placebo-controlled trial of 40 preterm infants born at less than or equal to 32 weeks and 0 days gestation. Infants will be randomized to receive either caffeine or placebo for up to maximum of additional four (4) weeks after meeting clinical criteria to come off caffeine.
Primary purpose: TREATMENT

Brief summary: This study aims to assess whether extending the duration of caffeine therapy will help preterm infants achieve full oral feeding faster.

Detailed description: This study is a randomized, double-blinded, placebo-controlled trial. Infants will be randomized to receive either caffeine or placebo for up to maximum of four additional weeks after meeting clinical criteria to discontinue caffeine. Initiation of oral feeding will be based on standard of care as determined by a neonatal occupational therapist and clinical cues. Oral feedings will be advanced by a standardized 5 step oral feeding protocol. The time it takes to achieve full oral feeds between the treatment and control groups will be compared.

Eligibility criteria: Inclusion Criteria:

• Infants born at equal to or less than 32 weeks and 0 days gestational age AND

* Equal to or greater than 34 weeks and 0 days corrected gestation at time of enrollment.
* Off respiratory support for at least 2 days (nasal canula oxygen, high flow nasal canula, continuous positive airway pressure (CPAP), mechanical ventilation).
* On caffeine and meet criteria to discontinue caffeine.
* No significant cardiopulmonary events for at least 5 days (apnea \> 20 seconds, apnea with heart rate (HR) \< 80 beats per minute (bpm), HR \< 80 bpm with desaturation \< 85% or color change).

Exclusion Criteria:

* Infants with critical congenital heart disease.
* Infants with neuromuscular conditions affecting respiration.
* Infants with overt brain injury (i.e. severe Grade 3-4 intraventricular hemorrhage, cystic periventricular leukomalacia) that may affect oral feeding.
* Infants with major genetic disorders.
* Infants with anatomic anomalies that will hinder oral feeding.
* Infants who have already progressed to Step 3 (of 5) of our institution's oral feeding protocol (oral feeds 4 times per day).
* Infants who develop necrotizing enterocolitis after enrollment.
* Failure to obtain consent or declined by parents.

Primary outcomes:
measure: Time to full feeds
timeFrame: From first nutritive oral feed until full oral feeds achieved, up to 6 weeks
Secondary outcomes:
measure: Time to discharge
timeFrame: Randomization until discharge, up to 6 weeks
measure: Post menstrual age (PMA) at time of discharge
timeFrame: Randomization until discharge, up to 6 weeks
measure: Number of significant cardiopulmonary events
timeFrame: Randomization until discharge, up to 6 weeks
measure: Weight change
timeFrame: Randomization until discharge, up to 6 weeks
Other outcomes:
Locations:
city: Orange
country: United States
facility: UC Irvine Medical Center
state: California
Study officials:
affiliation: UC Irvine
name: Cherry Uy, MD
role: PRINCIPAL_INVESTIGATOR
References: