Comparative Effectiveness Study of Bubble CPAP Devices in the NICU

Respiratory Distress Syndrome Clinical Trial

Official title:

Comparative Effectiveness Study of Bubble CPAP Devices in the NICU

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02392806
• Other study ID #: SLU Protocol # 24949
• Status: Completed
• Phase: N/A
• First received: February 27, 2015
• Last updated: February 9, 2018
• Start date: January 2015
• Est. completion date: August 2016

Study information

• Verified date: February 2018
• Source: St. Louis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Primary outcome: Bubble CPAP failure (re-intubation or use of non-invasive positive pressure ventilation) within 72 hours following extubation Secondary outcome: Number of infants that reach 21% inspired oxygen during initial study period Secondary outcome: Apnea/bradycardia events in the initial study period Secondary outcome: Mean oxygen requirement following initial study period

Population: Infants born at <=1250 grams birth weight but >= 500 grams birth weight

Randomization: Equal allocation stratified by gestational age (<27 weeks, >=27 weeks)

Study diagram:

72h 24h X---------->X1----------->Y2 Y---------->Y1----------->X2 Infants will be randomly assigned to treatment X (BabiPlus, control group) or treatment Y (B&B Bubbler, intervention group). The primary outcome is bubble CPAP failure during the first 72 hours following extubation, measured at time point 1 in the diagram. Bubble CPAP failure is defined as requiring re-intubation or non-invasive positive pressure ventilation (NIPPV), requiring FiO2 of >60% for one hour or a pCO2 measurement of >65 mm Hg. For those infants that remain on CPAP during the initial study period, the number that reach 21% inspired oxygen for >12 consecutive hours will be compared between groups. This difference will also be analyzed using a Chi square test.

Those infants that remain on CPAP following the 72 hour initial study period (e.g., did not meet primary outcome criteria) will be crossed over to the opposite treatment arm for at least 24 hours. The minimum oxygen requirement required to keep the saturations in the ordered range, per standard NICU guidelines, will be recorded and compared between time points 1 and 2.

This study design is complex due to the nature of the disease of these patients. Each day every infant's premature pulmonary disease is evolving. There is no way to control for this.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 100 Days

Eligibility

Inclusion Criteria:

1. Infant delivered at >=500 grams and <=1250 grams birth weight.

2. Infant requires intubation for mechanical ventilation within the first 48 hours following delivery.

3. Infant has received exogenous surfactant during mechanical ventilation.

Exclusion Criteria:

1. Decision by attending physician to redirect to comfort care

2. Congenital condition that precludes the use of CPAP (choanal atresia, diaphragmatic hernia, etc.)

3. Birth weight >1250 grams or <500 grams.

4. Non-English speaking parents. -

Related Conditions & MeSH terms

• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Device:
• Bubble CPAP- BabiPlus, Respiralogics
Infant will be randomized to BabiPlus Bubbler at time of extubation
• Bubble CPAP- B&B Bubbler, B&B Medical devices
Infant will be randomized to B&B Bubbler at time of extubation

Locations

Country	Name	City	State
United States	Cardinal Glennon Children's Hospital	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Marya Strand, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Extubation Failure	Bubble CPAP failure (re-intubation or use of non-invasive positive pressure ventilation) within 72 hours following extubation	Within 72 hours of extubation
Secondary	Oxygenation - Oxygen Saturation Via Pulse Oximetry Recorded Hourly	Number of infants that reach 21% inspired oxygen during initial study period of 72 hours plus the crossover period of 24 hours	96 hours