Effects of Caffeine on Intermittent Hypoxia in Infants Born Preterm

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Carl Hunt, American SIDS Institute
ClinicalTrials.gov Identifier:
NCT01875159
First received: June 3, 2013
Last updated: June 10, 2013
Last verified: June 2013
  Purpose

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%.


Condition Intervention Phase
Hypoxia
Drug: Caffeine citrate 6 mg/kg/day
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study of Effects of Caffeine on Intermittent Hypoxia in Infants Born Preterm

Resource links provided by NLM:


Further study details as provided by American SIDS Institute:

Primary Outcome Measures:
  • Episodes and seconds/hour of intermittent hypoxia [ Time Frame: Baseline and 40 weeks postmenstrual age ] [ Designated as safety issue: No ]
    Intermittent hypoxia: number of episodes per hour of pulse oximeter recording of oxygen saturation to less than 90%, and sec/hour of recording to less than 90%.


Enrollment: 105
Study Start Date: July 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Caffeine
Caffeine citrate 6 mg/kg/day
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.
Other Name: Cafcit
No Intervention: 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.

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 and the frequency/duration of bradycardia will be compared between the caffeine group and the usual care (no-caffeine) group for each week of physiologic data recordings.

  Eligibility

Ages Eligible for Study:   33 Weeks to 37 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01875159

Locations
United States, Maryland
Uniformed Services University of Health Sciences
Bethesda, Maryland, United States, 20814
Sponsors and Collaborators
American SIDS Institute
Investigators
Study Director: Betty McEntire, PhD American SIDS Instittute
  More Information

No publications provided by American SIDS Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Carl Hunt, Research Professor of Pediatrics, American SIDS Institute
ClinicalTrials.gov Identifier: NCT01875159     History of Changes
Other Study ID Numbers: ASI 01
Study First Received: June 3, 2013
Last Updated: June 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by American SIDS Institute:
Prematurity
Apnea of prematurity
Intermittent hypoxia

Additional relevant MeSH terms:
Caffeine
Caffeine citrate
Central Nervous System Agents
Central Nervous System Stimulants
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Phosphodiesterase Inhibitors
Physiological Effects of Drugs
Purinergic Agents
Purinergic Antagonists
Purinergic P1 Receptor Antagonists
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014