CO2 Inhalation as a New Treatment Modality for Apnea of Prematurity

University of Manitoba

Status and phase: Completed; Phase 3; Phase 2

Conditions: Apnea of Prematurity

Treatments: Other: CO2 inhalation; Drug: Theophylline

Study type: Interventional

Funder types: Other

Identifiers

NCT01066728

E98:242

Details and patient eligibility

About

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.

Full 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.

Enrollment: 87 patients

Sex: All

Ages: 27 to 32 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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87 participants in 2 patient groups

Theophylline

Active Comparator group

Description:

Oral loading dose of 6 mg per kilogram of body weight of theophylline followed by a maintenance dose of 2 mg per kilogram every 8 hours plus room air by nasal prongs at 0.5 l/min for 3 days.

Treatment:

Drug: Theophylline

CO2 inhalation

Experimental group

Description:

Equivalent loading and maintenance volume of oral normal saline plus CO2 (3% at the source, approximately 1% inhaled) with room air by nasal prongs at 0.5 l/min for 3 days

Treatment:

Other: CO2 inhalation