Influence of Oxygen Target Range on Intermittent Hypoxemia in Preterm Infants

University of Ulm

Status: Unknown

Conditions: Apnea of Prematurity; Intermittent Hypoxemia

Treatments: Drug: Oxygen

Study type: Interventional

Funder types: Other

Identifiers

NCT02743988

ULMNEONIRS05

Details and patient eligibility

About

In this randomized crossover trial, preterm infants with intermittent hypoxemia and need for supplemental oxygen will be randomized to either Sequence of two different oxygen target ranges (low: 85-89%; high: 91-95%) for a total duration of 19 hours. Cerebral oxygenation, cardiac output, arterial oxygenation and heart rate will be measured continuously. Primary outcome is time with arterial oxygen saturation < 80%.

Enrollment: 36 estimated patients

Sex: All

Ages: 21 to 42 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• preterm infant < 29 weeks gestation
• at least 8 hypoxemic events during 8 hours
• requires supplemental oxygen to achieve high SpO2 target range
• parental consent given

Exclusion criteria

• congenital life-threatening malformation
• fatal outcome expected
• airway malformation
• higher grade intraventricular bleeding (grade III or IV according to LA Papile)
• posthaemorrhagic hydrocephalus
• life-threatening disease at the time of study entry

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Low target range

Experimental group

Description:

Low oxygen saturation target range: SpO2 85-89%

Treatment:

Drug: Oxygen

High target range

Active Comparator group

Description:

High oxygen saturation target range: SpO2 91-95%

Treatment:

Drug: Oxygen