Comparative Effectiveness Study of Bubble CPAP Devices in the NICU

Completed · Not applicable

Conditions studied: Respiratory Distress Syndrome

In brief

Multiple different devices are available to provide Bubble CPAP to preterm and newborn infants. The most significant difference between these devices is the size of the bubble produced by the exhalation limb. This study will determine if one Bubble CPAP device (BabiPlus vs B\&B) is more effective in improving oxygenation and decreasing extubation failure in the extremely low birthweight population.

Key facts

Study ID

NCT02392806

Run by

Marya Strand, MD

People needed

43

Starts

2015-01-01

Expected to finish

2016-08-01

Last updated by the study team

2018-03-09

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Infant delivered at >=500 grams and <=1250 grams birth weight.
• Infant requires intubation for mechanical ventilation within the first 48 hours following delivery.
• Infant has received exogenous surfactant during mechanical ventilation.

You may not qualify if…

• Decision by attending physician to redirect to comfort care
• Congenital condition that precludes the use of CPAP (choanal atresia, diaphragmatic hernia, etc.)
• Birth weight >1250 grams or <500 grams.
• Non-English speaking parents. -

Where it is running

• Cardinal Glennon Children's Hospital — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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