Environmental or Nasal Cannula Oxygen for Preterm Infants Receiving Oxygen Therapy: a Randomized Cross-over Pilot Study

Completed · Not applicable

Conditions studied: Infant, Newborn, Diseases, Hypoxia

In brief

The purpose of this study is to determine if, in preterm infants \< 37 weeks' gestation at birth receiving oxygen without ventilatory/CPAP support, oxygen environment (OE) compared with nasal cannula oxygen (NC), will decrease the number of episodes with oxygen saturations less than 85% of ≥10 seconds in a 48 hour cross over period on either intervention. This is a randomized cross-over pilot study with a 1:1 parallel allocation of infants to oxygen environment or nasal cannula oxygen using stratified permuted block design. Following a 24 hour period on the first intervention, infants will cross over to a 24 hour period on the second (alternative) intervention before crossing back to the first intervention for a further 24 hours and then back again to the second (alternative) intervention for a further 24 hours.

Key facts

Study ID

NCT02794662

Run by

University of Alabama at Birmingham

People needed

25

Starts

2016-04-01

Expected to finish

2016-09-01

Last updated by the study team

2016-12-01

Who can join

Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Infant requiring supplemental oxygen therapy via oxygen environment (OE) or nasal cannula (NC) with flow rates ≤ 1.0 liter per kilogram per minute
• Off ventilatory support and/or NCPAP for > 48 hours prior to study entry
• Gestational age < 37 weeks' gestation at birth
• Nursed in incubator for thermoregulation
• Parents/legal guardians have provided consent for enrollment

You may not qualify if…

• A major malformation
• A neuromuscular condition that affects respiration
• Terminal illness or decision to withhold or limit support

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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