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CO2 Inhalation as a New Treatment Modality for Apnea of Prematurity

Information source: University of Manitoba
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Apnea of Prematurity

Intervention: CO2 inhalation (Other); Theophylline (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: University of Manitoba

Official(s) and/or principal investigator(s):
Ruben E Alvaro, MD, Principal Investigator, Affiliation: University of Manitoba

Summary

The objective of the present proposed study is to discover whether, in the nursery setting, administration of low concentration inhaled CO2 (0. 8%) for a prolonged period (3 days) can make breathing more regular with less apneic time than that observed with administration of theophylline. The hypothesis to be tested is that inhalation of low concentration CO2 (0. 8%) will reduce apnea more effectively and will have fewer adverse side effects than theophylline.

Clinical Details

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: The decrease in total apnea time (duration of all apneic pauses ≥ 5 seconds) during administration of theophylline and carbon dioxide.

Secondary outcome: Decrease in the rate of long apneas (≥ 20 seconds) and the incidence of short term side effects

Detailed description: 1. To discover whether, in the nursery setting, continuous administration of a low concentration of inhaled CO2 (0. 8%) for a prolonged period (3 days) can make breathing in preterm infants more regular with less apneic time than that observed with theophylline. 2. To discover whether inhalation of low CO2 decreases apneas, particularly prolonged apneas (>20 seconds), more effectively than theophylline. 3. To discover whether short term (during hospitalization) and long term (2 years) adverse side effects are less pronounced with CO2 than with theophylline.

Eligibility

Minimum age: 27 Weeks. Maximum age: 32 Weeks. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Infants between 27 and 32 weeks gestational age hospitalized in the neonatal

intensive or intermediate care units

- Significant apnea, defined as 5 or more self-resolved apneas, or 2 or more apneas

requiring intervention over a 12 hr period Exclusion Criteria:

- Already on methylxanthine treatment

- On supplemental oxygen, nasal continuous positive airway pressure (CPAP)

- Had major congenital anomalies, sepsis, or other known causes of apnea

Locations and Contacts

Health Sciences Centre, Winnipeg, Manitoba R3E 0L8, Canada

St Boniface General Hospital, Winnipeg, Manitoba R2H 2A6, Canada

Additional Information

Related publications:

Al-Saif S, Alvaro R, Manfreda J, Kwiatkowski K, Cates D, Qurashi M, Rigatto H. A randomized controlled trial of theophylline versus CO2 inhalation for treating apnea of prematurity. J Pediatr. 2008 Oct;153(4):513-8. doi: 10.1016/j.jpeds.2008.04.025. Epub 2008 Jun 4.

Al-Aif S, Alvaro R, Manfreda J, Kwiatkowski K, Cates D, Rigatto H. Inhalation of low (0.5%-1.5%) CO2 as a potential treatment for apnea of prematurity. Semin Perinatol. 2001 Apr;25(2):100-6.

Schmidt B, Roberts RS, Davis P, Doyle LW, Barrington KJ, Ohlsson A, Solimano A, Tin W; Caffeine for Apnea of Prematurity Trial Group. Long-term effects of caffeine therapy for apnea of prematurity. N Engl J Med. 2007 Nov 8;357(19):1893-902.

Schmidt B, Roberts RS, Davis P, Doyle LW, Barrington KJ, Ohlsson A, Solimano A, Tin W; Caffeine for Apnea of Prematurity Trial Group. Caffeine therapy for apnea of prematurity. N Engl J Med. 2006 May 18;354(20):2112-21.

Bucher HU, Duc G. Does caffeine prevent hypoxaemic episodes in premature infants? A randomized controlled trial. Eur J Pediatr. 1988 Apr;147(3):288-91.

Dunwiddie TV, Masino SA. The role and regulation of adenosine in the central nervous system. Annu Rev Neurosci. 2001;24:31-55. Review.

Xie A, Rankin F, Rutherford R, Bradley TD. Effects of inhaled CO2 and added dead space on idiopathic central sleep apnea. J Appl Physiol (1985). 1997 Mar;82(3):918-26.

Starting date: August 2001
Last updated: March 1, 2010

Page last updated: August 23, 2015

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