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Trial record 19 of 94 for:    SIDS

Effects of Caffeine on Intermittent Hypoxia in Infants Born Preterm

This study has been completed.
Information provided by (Responsible Party):
Carl Hunt, American SIDS Institute Identifier:
First received: June 3, 2013
Last updated: March 16, 2015
Last verified: March 2015
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
Drug: Caffeine citrate 6 mg/kg/day
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
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 Carl Hunt, American SIDS Institute:

Primary Outcome Measures:
  • Episodes of Intermittent Hypoxia Per Hour [ Time Frame: 35, 36, 37, 38 weeks postmenstrual age ]
    Number of episodes of Intermittent hypoxia per hour of pulse oximeter recording less than 90% oxygen saturation

  • Number of Seconds of Intermittent Hypoxia Per Hour [ Time Frame: 35, 36, 37, 38 weeks postmenstrual age ]
    Number of seconds of Intermittent hypoxia per hour of pulse oximeter recording less than 90% oxygen saturation

Enrollment: 98
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 will be compared between the caffeine group and the usual care (no-caffeine) group for each week of physiologic data recordings.

Ages Eligible for Study:   33 Weeks to 37 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01875159

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

Responsible Party: Carl Hunt, Research Professor of Pediatrics, American SIDS Institute Identifier: NCT01875159     History of Changes
Other Study ID Numbers: ASI 01
Study First Received: June 3, 2013
Results First Received: January 14, 2014
Last Updated: March 16, 2015

Keywords provided by Carl Hunt, American SIDS Institute:
Apnea of prematurity
Intermittent hypoxia

Additional relevant MeSH terms:
Signs and Symptoms, Respiratory
Signs and Symptoms
Caffeine citrate
Citric Acid
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Calcium Chelating Agents
Chelating Agents
Sequestering Agents processed this record on May 25, 2017