Clinical trial NCT01875159: Effects of Caffeine on Intermittent Hypoxia in Infants Born Preterm
Official title: Pilot Study of Effects of Caffeine on Intermittent Hypoxia in Infants Born Preterm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypoxia
Keywords: Prematurity
Apnea of prematurity
Intermittent hypoxia
Lead sponsor: American SIDS Institute
Sponsor class: OTHER
First posted: 2013-06-11
Enrollment: 98
Sex: ALL
Minimum age (years): 33
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this pilot study is to document the extent to which intermittent hypoxia persists beyond the age of discontinuing clinical methylxanthine, and will assess the effect of caffeine treatment on the number of intermittent hypoxia episodes and the total number of seconds with a hemoglobin oxygen saturation (HbO2 SAT) below 90%.

Detailed description: Infants with prior clinical treatment with caffeine in the neonatal intensive care unit (NICU) will be enrolled and continuous physiologic data recording of oxygen hemoglobin saturation (HbO2 SAT) and heart rate will begin as early as 33 weeks postmenstrual age (PMA). Randomization will occur when enrolled infants reach a corrected gestational age of at least 34 weeks PMA AND clinical caffeine has been discontinued for at least 5 days. Infants will be randomized to receive caffeine or to continue with usual care. The group randomized to start caffeine will receive an oral loading dose of caffeine citrate of 20 mg/kg on Day #1, followed by a single daily oral maintenance dose of 6 mg/kg starting on Day #2 and continued daily thereafter until 40 weeks PMA. The continuous oximeter recordings will be stopped at the same time. The number of intermittent hypoxia events/hour per week will be compared between the caffeine group and the usual care (no-caffeine) group for each week of physiologic data recordings.

Eligibility criteria: Inclusion Criteria:

1. Gestational age of 25 + 0 to 32 + 0 weeks PMA at birth, and 34 + 0 to 375 + 6 weeks PMA at randomization
2. Prior treatment with caffeine based on routine clinical indications, and clinical caffeine now discontinued ≥5 days before randomization
3. Previously tolerated clinical treatment with caffeine
4. Breathing room air (no current supplemental O2 treatment; may have previously required respiratory support)
5. Parental consent to enroll in pilot study

Exclusion Criteria:

1. Congenital syndrome or other medical diagnosis associated with known risk for neurodevelopmental abnormality, including intraventricular hemorrhage Grade 3 or greater, cyanotic congenital heart disease, confirmed central nervous system infection, or fetal alcohol syndrome
2. Currently receiving supplemental oxygen, ventilatory support, or nasal airflow therapy
3. Clinical decision to restart caffeine prior to completing 5 days of continuous physiologic monitoring after clinical caffeine stopped
4. Anticipated inability to meet protocol requirements

Primary outcomes:
measure: Episodes of Intermittent Hypoxia Per Hour
timeFrame: 35, 36, 37, 38 weeks postmenstrual age
measure: Number of Seconds of Intermittent Hypoxia Per Hour
timeFrame: 35, 36, 37, 38 weeks postmenstrual age
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Uniformed Services University of Health Sciences
state: Maryland
Study officials:
affiliation: American SIDS Instittute
name: Betty McEntire, PhD
role: STUDY_DIRECTOR
References:
citation: Rhein LM, Dobson NR, Darnall RA, Corwin MJ, Heeren TC, Poets CF, McEntire BL, Hunt CE; Caffeine Pilot Study Group. Effects of caffeine on intermittent hypoxia in infants born prematurely: a randomized clinical trial. JAMA Pediatr. 2014 Mar;168(3):250-7. doi: 10.1001/jamapediatrics.2013.4371.