Effects of Caffeine on Intermittent Hypoxia in Infants Born Preterm

NCT ID: NCT01875159

Last Updated: 2015-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2011-12-31

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.

Conditions

Hypoxia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Caffeine

Caffeine citrate 6 mg/kg/day

Group Type: EXPERIMENTAL

Caffeine citrate 6 mg/kg/day

Intervention Type: DRUG

Comparison of caffeine citrate 6 mg/kg/day versus no caffeine (usual care) on extent of intermittent hypoxia at 35, 36, 37, 38, 39, and 40 weeks postmenstrual age.

Active Comparator: no caffeine

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Caffeine citrate 6 mg/kg/day

Comparison of caffeine citrate 6 mg/kg/day versus no caffeine (usual care) on extent of intermittent hypoxia at 35, 36, 37, 38, 39, and 40 weeks postmenstrual age.

Intervention Type: DRUG

Other Intervention Names

Cafcit

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

• Minimum Eligible Age: 33 Weeks
• Maximum Eligible Age: 37 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American SIDS Institute

OTHER

Sponsor Role: lead

Responsible Party

Carl Hunt

Research Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Betty McEntire, PhD

Role: STUDY_DIRECTOR

American SIDS Instittute

Locations

Uniformed Services University of Health Sciences

Bethesda, Maryland, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 24445955 (View on PubMed)

Other Identifiers

ASI 01

Identifier Type: -

Identifier Source: org_study_id