Effects of Targeting Lower Arterial Oxygen Saturations on the Development of Control of Breathing in Very Preterm Infants

University of Manitoba

Status and phase: Completed; Phase 3; Phase 2

Conditions: Development of Control of Breathing

Treatments: Other: Oxygen saturation range

Study type: Interventional

Funder types: Other

Identifiers

NCT00573053

B2007:157

Details and patient eligibility

About

To determine whether targeting lower arterial oxygen saturations from the day of birth alters the early (first 3 months) postnatal development of the control of ventilation and the hypercapnic and hyperoxic responses in very preterm infants.

Full description

To measure the effects of baseline oxygenation in extremely low birth weight preterm infants on:

i) The early (first 5 breaths) and late or steady state (3-5 minutes) ventilatory response to CO2 ii) The immediate (< 1 minute) ventilatory response to hyperoxia iii) The PCO2 apneic threshold iv) The breathing pattern during quiet and REM sleep v) The morphology of periodic breathing cycles vi) The incidence and morphology of sighs

Enrollment: 26 estimated patients

Sex: All

Ages: 21 to 70 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Gestational age 23 0/7 - 27 6/7 weeks
• Enrolled in the COT trial at the Health Sciences Centre and the St. Boniface General Hospital in Winnipeg
• Postnatal age between 21 days and 70 days
• Informed written consent obtained from at least one of the parents.

Exclusion criteria

• Need for mechanical ventilation, NCPAP or O2
• Sepsis or other known causes of apnea.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

26 participants in 2 patient groups

High

Active Comparator group

Description:

Arterial oxygen saturations in the range of 91-95%

Treatment:

Other: Oxygen saturation range

Other: Oxygen saturation range

Low

Experimental group

Description:

Arterial oxygen saturations in the range of 85-89%

Treatment:

Other: Oxygen saturation range

Other: Oxygen saturation range