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Inhalation of Low Concentration of CO2 in Preterm Infants Not Responding to Caffeine for the Treatment of Apnea

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ClinicalTrials.gov Identifier: NCT01911182
Recruitment Status : Terminated (Low recruitment rate)
First Posted : July 30, 2013
Last Update Posted : February 19, 2015
Sponsor:
Collaborator:
Manitoba Institute of Child Health
Information provided by (Responsible Party):
Ruben Alvaro, University of Manitoba

Brief Summary:
In premature infants, apnea of prematurity is one of their major clinical problems. Caffeine is currently a worldwide therapy to reduce the number and severity of these apneas. This practice has shown to be safe on cognitive and neurodevelopmental outcomes at 18 to 21 months of age. However, caffeine is not 100% effective, and may have little effect on hypoxemia and bradycardia. Infants with intractable apneas unresponsive to caffeine treatment may require endotracheal intubation and mechanical ventilation. This procedure is invasive and has been associated with complications and increased risk for chronic lung disease and adverse neurodevelopmental outcome. Therefore, an alternative treatment modality would be preferable if it would prevent the infants from requiring endotracheal intubation. The investigators have been testing the overall hypothesis that small concentrations of inhaled CO2 (~1%) are effective in treating apnea of prematurity. The investigators have completed three studies in preterm infants showing that inhalation of low concentration of CO2, in infants not on caffeine, regularize breathing and decrease apneas significantly. The effects of inhalation of CO2 in infants already on caffeine, are unknown. The hypothesis to be tested is that inhalation of low concentration CO2 (1%) will significantly reduce apnea in infants treated with caffeine. The investigators have three specific aims in this proposal. 1) the investigators want to know if the apnea rate (number of apneas of ≥5 seconds/hour) is decreased with CO2 inhalation in preterm infants already on caffeine for the treatment of apnea of prematurity; 2) the investigators want to know whether inhalation of CO2 can make breathing more regular with less apneic time and whether it decreases prolonged apneas (>20 seconds) in infants already on caffeine for the treatment of apnea of prematurity; 3) the investigators want to assess the effect of inhalation of low concentration of CO2 on the regional oxygen saturation of the brain measured by near-infrared spectroscopy (NIRS) during apneas. This is to see whether CO2, by protecting cerebral blood flow, minimizes the decrease in cerebral oxygenation during apneas. This study entails a new and possibly more physiological method of treating apneas of prematurity that can be added to the present treatment of caffeine. These two treatments together, could minimize the number and severity of apneas and possibly decrease the need for mechanical ventilation in preterm infants.

Condition or disease Intervention/treatment Phase
Apnea of Prematurity Other: Inhalation of low concentration of CO2 Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Controlled Trial of Inhalation of Low Concentration of CO2 in Preterm Infants Not Responding to Caffeine for the Treatment of Apnea of Prematurity
Study Start Date : October 2011
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine

Arm Intervention/treatment
Experimental: Inhalation of low concentration of CO2 Other: Inhalation of low concentration of CO2
Inhalation of 1% CO2 through nasal prongs
Other Name: Inhalatio of biological gas

Active Comparator: caffeine only Other: Inhalation of low concentration of CO2
Inhalation of 1% CO2 through nasal prongs
Other Name: Inhalatio of biological gas




Primary Outcome Measures :
  1. Effect of inhalation of low concentration of CO2 (1%) on the apnea rate (number of apneas of ≥5 seconds/hour) in preterm infants already on caffeine for the treatment of apnea of prematurity. [ Time Frame: 3 hours ]

Secondary Outcome Measures :
  1. Effect of low concentration of CO2 on apneic time in seconds per hour and duration of long apneas in seconds [ Time Frame: 3 hours ]


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Ages Eligible for Study:   up to 60 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • gestational age at birth < 33 weeks
  • on caffeine treatment for apnea of prematurity at a maintenance dose of 5 mg/kg/day
  • having apnea of prematurity (at least 5 self-resolved apneas or 2 apneas requiring intervention/12 hours)

Exclusion Criteria:

  • on mechanical ventilation
  • presence of congenital anomalies, sepsis or other known causes of apnea
  • failure to obtain parental consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01911182


Locations
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Canada, Manitoba
University of Manitoba
Winnipeg, Manitoba, Canada, R3E 0L8
Sponsors and Collaborators
University of Manitoba
Manitoba Institute of Child Health
Investigators
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Principal Investigator: Ruben E Alvaro, MD University of Manitoba

Publications:

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Responsible Party: Ruben Alvaro, Associate Professor of Pediatrics, University of Manitoba
ClinicalTrials.gov Identifier: NCT01911182     History of Changes
Other Study ID Numbers: B2011:072
First Posted: July 30, 2013    Key Record Dates
Last Update Posted: February 19, 2015
Last Verified: February 2015
Keywords provided by Ruben Alvaro, University of Manitoba:
apnea of prematurity
control of breathing
newborn
CO2 inhalation
Additional relevant MeSH terms:
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Apnea
Respiratory Aspiration
Premature Birth
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Pathologic Processes
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Caffeine
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