Effects of Caffeine on Intermittent Hypoxia in Infants Born Preterm

American SIDS Institute

Status and phase: Completed; Phase 3

Conditions: Hypoxia

Treatments: Drug: Caffeine citrate 6 mg/kg/day

Study type: Interventional

Funder types: Other

Identifiers

NCT01875159

ASI 01

Details and patient eligibility

About

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%.

Full 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.

Enrollment: 98 patients

Sex: All

Ages: 33 to 37 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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98 participants in 2 patient groups

Caffeine

Experimental group

Description:

Caffeine citrate 6 mg/kg/day

Treatment:

Drug: Caffeine citrate 6 mg/kg/day

Active Comparator: no caffeine

No Intervention group

Description:

Compare extended use of caffeine citrate 6 mg/kg/day to no caffeine (usual care) in regard to extent of intermittent hypoxia from 35 weeks postmenstrual age (PMA) to 40 weeks PMA.