Effects of Caffeine on Intermittent Hypoxia in Infants Born Preterm

Hypoxia Clinical Trial

Official title:

Pilot Study of Effects of Caffeine on Intermittent Hypoxia in Infants Born Preterm

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01875159
• Other study ID #: ASI 01
• Status: Completed
• Phase: Phase 3
• First received: June 3, 2013
• Last updated: March 16, 2015
• Start date: July 2010
• Est. completion date: December 2011

Study information

• Verified date: March 2015
• Source: American SIDS Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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%.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 33 Weeks to 37 Weeks

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypoxia

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Uniformed Services University of Health Sciences	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
American SIDS Institute

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. d — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Episodes of Intermittent Hypoxia Per Hour	Number of episodes of Intermittent hypoxia per hour of pulse oximeter recording less than 90% oxygen saturation	35, 36, 37, 38 weeks postmenstrual age	No
Primary	Number of Seconds of Intermittent Hypoxia Per Hour	Number of seconds of Intermittent hypoxia per hour of pulse oximeter recording less than 90% oxygen saturation	35, 36, 37, 38 weeks postmenstrual age	No